Identification of factors contributing to recurrence of...
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Identification of factors contributing to recurrence of venous leg ulcers PhD Candidate: Kathleen Finlayson, BN, MNurs. Year: 2010 School: School of Nursing & Midwifery Research Centre: Institute of Health and Biomedical Innovation This thesis is submitted to fulfil the requirements for the degree of Doctor of Philosophy at Queensland University of Technology
Transcript of Identification of factors contributing to recurrence of...
Identification of factors contributing to recurrence
of venous leg ulcers
PhD Candidate: Kathleen Finlayson, BN, MNurs.
Year: 2010
School: School of Nursing & Midwifery
Research Centre: Institute of Health and Biomedical Innovation
This thesis is submitted to fulfil the requirements for the degree of Doctor of
Philosophy at Queensland University of Technology
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ABSTRACT
Background and Significance
Venous leg ulcers are a significant cause of chronic ill-health for 1–3% of those
aged over 60 years, increasing in incidence with age. The condition is difficult and
costly to heal, consuming 1–2.5% of total health budgets in developed countries and
up to 50% of community nursing time. Unfortunately after healing, there is a
recurrence rate of 60 to 70%, frequently within the first 12 months after heaing.
Although some risk factors associated with higher recurrence rates have been
identified (e.g. prolonged ulcer duration, deep vein thrombosis), in general there is
limited evidence on treatments to effectively prevent recurrence. Patients are
generally advised to undertake activities which aim to improve the impaired venous
return (e.g. compression therapy, leg elevation, exercise). However, only
compression therapy has some evidence to support its effectiveness in prevention
and problems with adherence to this strategy are well documented.
Aim
The aim of this research was to identify factors associated with recurrence by
determining relationships between recurrence and demographic factors, health,
physical activity, psychosocial factors and self-care activities to prevent recurrence.
Methods
Two studies were undertaken: a retrospective study of participants diagnosed
with a venous leg ulcer which healed 12 to 36 months prior to the study (n=122);
and a prospective longitudinal study of participants recruited as their ulcer healed
and data collected for 12 months following healing (n=80). Data were collected from
medical records on demographics, medical history and ulcer history and treatments;
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and from self-report questionnaires on physical activity, nutrition, psychosocial
measures, ulcer history, compression and other self-care activities. Follow-up data
for the prospective study were collected every three months for 12 months after
healing. For the retrospective study, a logistic regression model determined the
independent influences of variables on recurrence. For the prospective study,
median time to recurrence was calculated using the Kaplan-Meier method and a
Cox proportional-hazards regression model was used to adjust for potential
confounders and determine effects of preventive strategies and psychosocial factors
on recurrence.
Results
In total, 68% of participants in the retrospective study and 44% of participants in
the prospective study suffered a recurrence. After mutual adjustment for all variables
in multivariable regression models, leg elevation, compression therapy, self efficacy
and physical activity were found to be consistently related to recurrence in both
studies. In the retrospective study, leg elevation, wearing Class 2 or 3 compression
hosiery, the level of physical activity, cardiac disease and self efficacy scores
remained significantly associated (p<0.05) with recurrence. The model was
significant (p <0.001); with a R2 equivalent of 0.62. Examination of relationships
between psychosocial factors and adherence to wearing compression hosiery found
wearing compression hosiery was significantly positively associated with
participants’ knowledge of the cause of their condition (p=0.002), higher self-efficacy
scores (p=0.026) and lower depression scores (p=0.009).
Analysis of data from the prospective study found there were 35 recurrences
(44%) in the 12 months following healing and median time to recurrence was 27
weeks. After adjustment for potential confounders, a Cox proportional hazards
regression model found that at least an hour/day of leg elevation, six or more
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days/week in Class 2 (20–25mmHg) or 3 (30–40mmHg) compression hosiery,
higher social support scale scores and higher General Self-Efficacy scores
remained significantly associated (p<0.05) with a lower risk of recurrence, while
male gender and a history of DVT remained significant risk factors for recurrence.
Overall the model was significant (p <0.001); with an R2 equivalent 0.72.
Conclusions
The high rates of recurrence found in the studies highlight the urgent need for
further information in this area to support development of effective strategies for
prevention. Overall, results indicate leg elevation, physical activity, compression
hosiery and strategies to improve self-efficacy are likely to prevent recurrence. In
addition, optimal management of depression and strategies to improve patient
knowledge and self-efficacy may positively influence adherence to compression
therapy. This research provides important information for development of strategies
to prevent recurrence of venous leg ulcers, with the potential to improve health and
decrease health care costs in this population.
Keywords
venous leg ulcer, recurrence, prevention
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Table of Contents
ABSTRACT .............................................................................................................. 3
Background and Significance ........................................................................... 3 Aim .................................................................................................................. 3 Methods ........................................................................................................... 3 Results ............................................................................................................. 4 Conclusions ..................................................................................................... 5
Table of Contents ................................................................................................... 7
List of Publications and Conference Papers Related to the Research ............. 11
Journal Articles Published / In Press ...........................................................11 Conference Presentations ...........................................................................11
List of Figures ....................................................................................................... 13
Acknowledgments ................................................................................................ 14
Chapter 1 INTRODUCTION ................................................................................... 15
Research Problem ..........................................................................................16 Objectives .......................................................................................................18 Research Questions........................................................................................18
CHAPTER 2 LITERATURE REVIEW ..................................................................... 21
Introduction .........................................................................................................21
Search Strategy ..............................................................................................22 Levels of Evidence ..........................................................................................23
Wound Healing....................................................................................................24
Wound Healing at the Molecular Level ............................................................24 Factors Affecting Wound Healing at the Systems Level ..................................25
Physiological factors affecting wound healing .............................................25 Psychosocial factors affecting wound healing .............................................27
Venous Leg Ulcers ..............................................................................................29
Significance and Impact ..................................................................................29 Prevalence ..................................................................................................29 Cost ............................................................................................................30 Pain .............................................................................................................31 Oedema, eczema and exudate ...................................................................32 Reduced mobility and impaired functional ability .........................................33 Social isolation ............................................................................................34 Psychological impact ...................................................................................34 Decreased quality of life ..............................................................................35
Aetiology and Risk Factors ..............................................................................36 Aetiology of venous leg ulcers .....................................................................36 Risk factors for venous leg ulcers ................................................................37
Healing Venous Leg Ulcers .............................................................................39 Physiological factors affecting healing in venous leg ulcers .........................39
Age..........................................................................................................39 Nutrition ...................................................................................................40
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Ulcer size, duration and aetiology ........................................................... 41 Mobility and exercise .............................................................................. 42 Compression therapy .............................................................................. 43 Leg elevation .......................................................................................... 44 Surgery ................................................................................................... 45 Wound dressing ...................................................................................... 45 Additional therapies ................................................................................ 46
Psychological factors affecting healing in venous leg ulcers ....................... 47 Political and socio-economic factors affecting healing in venous leg ulcers 48
Socio-economic factors ........................................................................... 48 Health care systems and policies ............................................................ 49
Recurrence of Venous Leg Ulcers ...................................................................... 52
Recurrence Rates ........................................................................................... 52 Risk Factors for Recurrence ........................................................................... 53 Preventing Reurrence ..................................................................................... 54
Physiological factors influencing recurrence ............................................... 54 Compression ........................................................................................... 54 Surgery for venous incompetence ........................................................... 55 Leg elevation and exercise ..................................................................... 56 Nutrition .................................................................................................. 56
Psychological factors influencing recurrence .............................................. 57 Political and socio-economic factors influencing recurrence........................ 59
Socio-economic factors ........................................................................... 59 Health care system and policies .............................................................. 60
Summary of Literature on Venous Leg Ulcers ..................................................... 62
Conceptual Framework ....................................................................................... 64
Conclusion .......................................................................................................... 72
CHAPTER 3 A retrospective investigation of the impact of physiological variables, psychosocial factors and preventive self-care strategies on recurrence of venous leg ulcers.......................................................................... 75
Introduction ..................................................................................................... 75 Methods .......................................................................................................... 76
Design ........................................................................................................ 76 Research Questions ................................................................................... 76 Sample ....................................................................................................... 77
Inclusion Criteria ..................................................................................... 77 Exclusion Criteria .................................................................................... 77
Data collection and measures ..................................................................... 78 Instruments ............................................................................................. 79
Procedure ................................................................................................... 82 Data management ...................................................................................... 83
Data cleaning and consistency checking ................................................. 83 Data analysis .............................................................................................. 84
Results and Discussion .................................................................................. 86 Conclusion ...................................................................................................... 95
CHAPTER 4 The impact of psychosocial factors on adherence to compression therapy to prevent recurrence of venous leg ulcers. ......................................... 97
Introduction ..................................................................................................... 97
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Methods ..........................................................................................................98 Research Questions ....................................................................................98 Design .........................................................................................................99 Sample ........................................................................................................99 Data Collection and Measures ....................................................................99 Procedure and data management ...............................................................99 Data analysis ............................................................................................ 100
Results and Discussion ................................................................................. 101 Conclusion .................................................................................................... 111
CHAPTER 5 Relationships between preventive activities, psychosocial factors and recurrence of venous leg ulcers: A prospective study. ........................... 113
Introduction ................................................................................................... 113 Methods ........................................................................................................ 114
Design ....................................................................................................... 114 Research Questions .................................................................................. 114 Sample ...................................................................................................... 115 Data collection and measures ................................................................... 115 Procedure ................................................................................................. 116 Data management and cleaning ................................................................ 116 Data analysis ............................................................................................ 117
Results and Discussion ................................................................................. 120 Conclusion .................................................................................................... 155
CHAPTER 6 OVERVIEW AND DISCUSSION ...................................................... 157
Overview of Results and Contribution to Current Knowledge ........................ 157 Overview of results in relation to the research questions ........................... 158
Demographics, health and recurrence ................................................... 158 Physical activity and recurrence ............................................................ 159 Psychosocial variables and recurrence ................................................. 160 Self care activities and recurrence ......................................................... 161 Adherence to self care activities ............................................................ 162
Overall View .............................................................................................. 163 Contribution of Results to Conceptual Framework ........................................ 164 Strengths and Limitations .............................................................................. 168 Recommendations ........................................................................................ 169
Clinical practice ......................................................................................... 169 Education .................................................................................................. 170 Research ................................................................................................... 170
Conclusion .................................................................................................... 171
Appendix A Survey Instruments ........................................................................ 173
Appendix B Statements of Contribution of Co-Authors for Thesis by Published Papers ................................................................................................................. 186
REFERENCES ..................................................................................................... 189
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List of Publications and Conference Papers Related to the Research
Journal Articles Published / In Press
Finlayson, K., Edwards, H., Courtney, M. (2010) Relationships between preventive
activities, psychosocial factors and recurrence of venous leg ulcers: A prospective
study. Journal of Advanced Nursing, accepted subject to minor changes on
10/2/2010, Manuscript ID JAN-2009-0895.
Finlayson, K., Edwards, H., Courtney, M. (2010) The impact of psychosocial factors
on adherence to compression therapy to prevent recurrence of venous leg ulcers.
Journal of Clinical Nursing, 19: 1289 – 1297.
Finlayson, K., Edwards, H., Courtney, M. (2009) Factors associated with recurrence
of venous leg ulcers: A survey and retrospective chart review. International Journal
of Nursing Studies, 46 (8): 1071 – 1078.
Conference Presentations
Finlayson K, Edwards H, Courtney, M. (2010) Preventive activities and risk of
recurrence of chronic venous leg ulcers: A prospective study. Proceedings
Australian Wound Management Association Biennial National Conference, 24 – 27
March 2010, Perth, WA: AWMA, p.49.
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Finlayson K, Edwards H, Courtney M. (2009) Preventing recurrence of chronic leg
ulcers. Proceedings Royal College Nursing Australia Annual Conference, 2-4
September 2009, Melbourne, VIC: RCNA, p.69.
Finlayson K, Edwards H, Courtney M. (2009) Leg elevation and risk of recurrence of
chronic venous leg ulcers – A prospective study. 19th International Congress of the
International Association of Gerontology and Geriatrics, Paris, 5–9 July 2009,
Journal of Nutrition, Health and Aging, 13 (S1): S302.
Finlayson K, Edwards H, Courtney M. (2009) The impact of psychosocial factors on
self-care activities to prevent recurrence of venous leg ulcers. Proceedings of the
Queensland Wound Care Association 2009 Biennial Wound Management
Conference, 13-15 August 2009, Brisbane, Qld: QWCA, p.16.
Finlayson K, Edwards H, Courtney M. (2008) Factors associated with recurring
venous leg ulcers. Proceedings of the Third Congress of the World Union of Wound
Healing Societies, June 4 – 8, 2008, Toronto, Canada, CD PW208.
Finlayson K, Edwards H, Courtney M. (2008) The role of self-care activities in
preventing the recurrence of venous leg ulcers: A cross-sectional survey.
Proceedings of the Australian Wound Management Association 7th National
Conference, Darwin, 7-10 May 2008; pp.93-94. (Best poster award for original
research)
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List of Figures
Figure 1. Popoola’s model for chronic wound management
(Reprinted from Holistic Nursing Practice, Vol 17, Popoola, M., ‘Complementary
therapy in chronic wound management: A holistic caring cast study and praxis
model’, p. 155, 2003, with permission from Wolters Kluwer Health)
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Figure 2. Grey et al.’s Framework for self and family management of chronic
conditions. (Reprinted from Nursing Outlook, Vol 54, Grey et al., ‘A framework for
the study of self-and family management of chronic conditions’, p. 282, 2006, with
permission from Elsevier)
.......................................................................................68
Figure 3. Conceptual framework for recurrence of venous leg ulcers
.....................71
Figure 4 Framework for Assessment and Management of Chronic Venous
Insufficiency .......................................................................................................... 166
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Acknowledgments
I would like to acknowledge the wonderful encouragement, enthusiasm, support,
and guidance provided by my supervisors, Professor Helen Edwards and Professor
Mary Courtney, towards the completion of this thesis and my development as a
researcher. Also, my heartfelt thanks to my husband Peter and my children Clare,
Kate and Cameron for their support and patience in adapting to my time
commitments during this process.
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Chapter 1
INTRODUCTION
Chronic leg ulcers are a significant cause of pain, immobility and decreased
quality of life for older adults in the US, Europe and Australia (Briggs & Closs, 2003),
increasing in incidence with age (Briggs & Closs, 2003; Margolis et al., 2002). The
condition is difficult and costly to heal, with the wounds requiring frequent dressing
and bandage changes for months, or often years of treatment. Once healed, there is
a recurrence rate of approximately 60 to 70% (Abbade et al., 2005; Barwell et al.,
2004), with the highest recurrence rates occurring within 3 months (Moffatt &
Dorman, 1995; Vowden & Vowden, 2005). Up to 50 to 60% recur within the first 12
months after healing (Erickson et al., 1995; Vowden & Vowden, 2005).
Although some clinical conditions have been associated with higher recurrence
rates, such as prolonged duration of the preceding ulcer (Barwell et al., 2000a;
Gohel et al., 2005b) and poor mobility (Vowden & Vowden, 2005), in general little is
known on factors predisposing to recurrence, or on treatments to effectively prevent
recurrence. A systematic review on compression for preventing recurrence of
venous leg ulcers found a small number of studies which demonstrated the use of
some compression was better than none, but there was little evidence on how much
or what type of compression is effective (Nelson et al., 2000). A mixture of
additional strategies are generally recommended to sufferers of venous leg ulcers in
order to prevent recurrence, such as leg elevation, exercise, good nutrition and skin
care, although there have been few investigations to support their effectiveness.
The aim of this study was to identify factors associated with recurrence of chronic
venous leg ulcers in order to provide information for the development of effective
preventive strategies.
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Research Problem
Chronic leg ulcers are associated with prolonged periods of restricted mobility
and decreased functional ability (Brem et al., 2004; Persoon et al., 2004), pain
(Husband, 2001; Nemeth et al., 2003), social isolation (Moffatt et al., 2006; Persoon
et al., 2004), poor psychological health (Ebbeskog & Ekman, 2001; Jones et al.,
2006) and decreased quality of life (Franks et al., 2003; Jull et al., 2004b). The
condition affects 1 – 3 % of the population aged over 60 years in the U.S., U.K.,
Europe and Australia (Briggs & Closs, 2003; Margolis et al., 2002) and prevalence
increases with age, rising from around 0.6% of the general adult population up to
2% - 5.6% of those aged over 65 years (Adam et al., 2003; Araujo et al., 2003;
Bergqvist et al., 1999).
Significant amounts of time and resources are invested in healing chronic venous
leg ulcers, including up to 50% of community nursing time spent managing the
condition (Royal District Nursing Service, 2008; Simon et al., 2004). Developed
countries spend approximately 1 – 2.5% of total health costs on care for chronic leg
ulcers (Nelzen, 1997), with treatment in the U.K. reported to cost £400 million each
year (Harding et al., 2002) and in the U.S.A. over 3 billion $US and the loss of over
2 million workdays a year (McGuckin et al., 2002). The cost to the Australian health
care system associated with chronic leg ulcers was reported to be approximately
$500 million/year in 1996 (Ramstadius, 1997).
Unfortunately, once healed, around 60 – 70% percent of venous leg ulcers recur
(McDaniel et al., 2002), many within the first three months of healing (Moffatt &
Dorman, 1995; Vowden & Vowden, 2005). There is little information available on the
effectiveness of strategies to prevent recurrence of venous leg ulcers or on factors
influencing recurrence. At present, patients are generally advised to wear
compression hosiery, be assessed for suitability for venous surgery, undertake leg
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exercises and leg elevation 3–4 times each day, be observant for signs of imminent
recurrence and maintain a healthy diet and weight, although it is unknown whether
most of these strategies are of any benefit.
There is some evidence that the use of compression therapy is better than no
compression (Franks et al., 1995c; Harper et al., 1999; Moffatt & Dorman, 1995), as
poor compliance with compression is associated with higher rates of recurrence
(Barwell et al., 2000a; Flanagan et al., 2001; Franks et al., 1995c). However there is
little information on the optimal type or level of compression necessary for
prevention (Nelson et al., 2000). In addition, superficial venous surgery has been
shown to help prevent recurrence in patients who do not have deep vein
involvement in their venous insufficiency (Barwell et al., 2004). This is beneficial for
this subgroup of patients, however, many patients are unsuitable or unwilling to
undertake surgery (Warwick et al., 2007).
Levels of activity and exercise are rarely measured in studies of recurrence
(Gethin, 2002). The effectiveness of exercise involving the lower limbs in preventing
recurrence has not been evaluated, although a few small physiological studies have
demonstrated exercise programs can improve calf muscle pump function in patients
with venous insufficiency (Padberg et al., 2004; Yang et al., 1999b). Conflicting
results have been reported on the link between poor mobility and recurrence rates,
with one small study finding reduced recurrence rates in patients who were fully
mobile with full ankle movement (Brooks et al., 2004), while a previous large study
in 2000 found no association between levels of mobility and recurrence rates
(Barwell et al., 2000a).
The impact of psychosocial characteristics such as depression and social support
on the physiological processes involved in acute wound healing has been discussed
in the literature, in addition to the impact of factors such as depression, social
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support and self efficacy on chronic disease self management activities. However,
these areas have not yet been explored in relation to prevention of recurrence of
venous leg ulcers. People with recurring leg ulcers frequently suffer years or
decades of chronic ill-health, social isolation and costly treatments (Baker & Stacey,
1994; Chase et al., 2000; Walshe, 1995). As the population aged over 65 years will
double in the next few decades (Australian Institute of Health & Welfare, 2002),
chronic leg ulcers will become increasingly prevalent. Improving the management of
this chronic disease and reducing recurrence rates are therefore vital.
Objectives
The objective of this research was to identify factors associated with recurrence
of venous leg ulcers in order to provide information for the development of effective
preventive strategies. The studies aimed to determine the association between
venous ulcer recurrence and:
• demographic, health and medical variables,
• venous history and ulcer characteristics,
• level of mobility and exercise,
• psychosocial variables, and
• self care activities related to management of chronic venous insufficiency.
Research Questions
1. Do recurrence rates vary according to demographic, health or venous
history variables in these samples?
2. What was the relationship between recurrence and level of physical
activity?
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3. What was the relationship between recurrence and the psychosocial
variables of depression, self-efficacy and social support?
4. What was the relationship between recurrence and self care activities
relating to chronic venous insufficiency?
5. Did adherence to self-care activities vary according to demographic,
health or psychosocial variables?
6. What were the independent relationships between recurrence and
demographic, health, physical, psychosocial and self care activity
variables after adjusting for all variables and potential confounders in a
multivariable regression model?
This research was undertaken in two stages: In Study 1 a retrospective review of
a sample of participants whose ulcers had healed betwee 12 to 36 months prior to
the study was undertaken; while in Study 2 a prospective study was undertaken of
participants recruited as their ulcer healed and data collected every three months for
12 months following healing.
In Chapter 2 a literature review of current knowledge on venous leg ulcers and
factors influencing recurrence of venous leg ulcers is provided, followed by the
conceptual framework upon which this research as based. Results from the
retrospective study (Study 1) are presented in Chapters 3 and 4. Chapter 3
describes the methods, results and discussion answering the research questions on
relationships between recurrence and demographic, health, physical activity,
psychosocial and self care activity variables (research questions 1, 2, 3, 4 and 6).
Chapter 4 describes the methods, results and discussion from analysis of the
retrospective study data to determine relationships between adherence to the self
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care activity of wearing compression hosiery and demographic, health and
psychosocial variables (research question 5). Chapter 5 describes the methods,
results and discussion from the prospective study, again investigating relationships
between recurrence and demographic, health, physical activity, psychosocial and
self care activity variables. Chapters 3, 4 and 5 are based on published articles, or
articles submitted for publication, which are provided within the chapters. Chapter 6
provides an overview of the results in total from both studies and a discussion on
how these results contribute to current knowledge and to the proposed conceptual
framework. Results from these studies contribute to improved knowledge of the
factors contributing to recurrence, with the potential to provide guidance for
preventive strategies, improve health and quality of life for those with the condition
and decrease costs to the health care system.
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CHAPTER 2
LITERATURE REVIEW
Introduction
Chronic leg ulcers affect 1–3 % of the population aged over 60 years and are
associated with prolonged ill-health, pain, restricted mobility and decreased quality
of life (Baker & Stacey, 1994; Chase et al., 2000; Walshe, 1995). Around 60 to 75%
of lower leg ulcers are venous in origin, developing as a consequence of chronic
venous insufficiency (CVI) from defective valves or obstruction in the venous system
(Nelson et al., 2000). The ulcers often take months or years to heal and frequently
recur, becoming a lifelong chronic condition. Compression therapy has been shown
to be an effective treatment for healing venous leg ulcers, with clinical trials reporting
healing rates of up to 60–80% following 12 to 24 weeks of treatment (Cullum et al.,
2001b). Unfortunately, once healed, as many as 60 to 70% of patients suffer an
ulcer recurrence, with the majority recurring within 12 months of healing (Abbade et
al., 2005; Barwell et al., 2004).
There is little evidence available on effective strategies to prevent ulcer
recurrence. Much of the advice currently provided to patients on prevention revolves
around strategies which aim to improve the impaired venous return (e.g.
compression therapy, leg elevation, exercise and avoiding long periods standing or
sitting), although only compression therapy has some evidence to support
effectiveness in prevention. Problems with compression therapy itself as a lifelong
prevention strategy are well documented, with many patients finding compression
garments uncomfortable, costly and difficult to apply, leading to poor rates of
compliance (Anand et al., 2003; Harker, 2000; Moffatt & Dorman, 1995; Seppanen &
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Livanainen, 2005). In addition, wound healing and breakdown is known to be a
complex process involving many factors, including not only circulation, but age
(Gosain, 2004), coexisting disease processes (Gosain et al., 2006), nutrition (Patel,
2005), psychological factors (Robles et al., 2005) and social influences (Moffatt et
al., 2006).
This literature review will examine current knowledge of wound healing as
relevant to venous leg ulcers, factors associated with recurring leg ulcers and
strategies to prevent recurrence. Areas of need for further research in prevention of
recurrent venous leg ulcers are then identified and a conceptual framework for
further investigation outlined.
Search Strategy
A search of the literature was conducted from 1980 – December 2009 using the
keyword search terms of venous, varicose, stasis, leg, ulcer* and recur*.
Databases searched were Medline, Cinahl, PsychINFO, Academic Search Elite,
EJS E-Journals, Biological Abstracts, Current Contents, ProQuest health databases,
the Cochrane Library Databases, ScienceDirect, Web of Science, Australian Digital
Theses Database, Networked Digital Library of Theses and ProQuest Dissertations
and Theses. In addition conference proceedings were searched from 2000 – 2009
on the websites of the European Wound Management Association, Australian
Wound Management Association, Wound Healing Society, Association for
Advances in Wound Care, Canadian Association of Wound Care, European Tissue
Repair Society and World Union of Wound Healing Societies.
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Levels of Evidence
Research studies identified on interventions to prevent venous leg ulcers or
interventions to heal venous leg ulcers have their level of evidence included
according to the following National Health and Medical Research Council Levels of
Evidence (National Health and Medical Research Council, 2007) for interventions as
follows:
Level I Evidence from a systematic review or meta-analysis of at least
two level II studies
Level II Evidence from a well designed randomised controlled trial (for
interventions), or a prospective cohort study (for prognostic
studies)
Level III-1 Evidence from a pseudo randomised controlled trial (i.e. alternate
allocation or some other method)
Level III-2 Evidence from comparative studies with concurrent controls
(non-randomised experimental trial, cohort study, case-control
study, interrupted time series with a control group)
Level III-3 Evidence from comparative studies without concurrent controls
(historical control study, interrupted time series without a parallel
control group, retrospective cohort study for prognostic studies)
Level IV Evidence from studies with no control or comparison group (case
series with either post-test or pre-test/post-test outcomes)
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Wound Healing
An understanding of normal wound healing processes and the factors influencing
healing in general is necessary before investigating abnormal wound healing.
Wound healing involves a number of complex activities and is influenced by factors
at both the biological microscopic level and at the larger systems level (e.g. mind,
body and social systems), with the circulatory and immune systems playing major
roles.
Wound Healing at the Molecular Level
Once an acute wound has damaged the normal integrity of skin and underlying
tissues, a complex sequence of interactions begins at the molecular level. Initially
the injured cells cause a process of haemostasis to occur, involving vascular
dilation, fibrin clot formation, platelet aggregation and eventually fibrin breakdown
(Faler et al., 2006; Gosain, 2004; Tsirogianni et al., 2006). An immune system
response commences, with the enzymes released from the injured cells activating
the next stage, the inflammatory stage. During the inflammatory stage an intricate
mix of cells such as neutrophils, macrophages and lymphocytes produce proteases,
pro-inflammatory cytokines and oxygen free radicals to break down any damaged or
non-viable tissue and act as agents of infection control (Faler et al., 2006; Gosain,
2004). In addition, the macrophages produce cytokines, growth factors and cell
adhesion molecules to facilitate cell migration and stimulate the following phase of
proliferation (Faler et al., 2006; Schultz et al., 2005). New tissue is then formed in
the proliferative stage, including granulation tissue, angiogenesis, collagen
synthesis, production of new extra-cellular matrix tissue, keratinocyte proliferation
and epithelialisation (Faler et al., 2006; Gosain, 2004; Tsirogianni et al., 2006). The
tissues finally undergo a remodelling phase, with scar formation and the return of
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tissue with normal strength and function (Blakytny & Jude, 2006; Schultz et al.,
2005; Tsirogianni et al., 2006).
Research indicates that the healing process in most chronic wounds seems to be
arrested in the inflammatory or proliferative phase and unable to progress normally
(Enoch & Price, 2004). An exaggerated inflammatory response has been found in
chronic wounds, with higher numbers of inflammatory cells and subsequent
increased levels of proteases, which break down new tissue and/or or denature the
growth factors needed for healing (Faler et al., 2006; Schultz et al., 2005).
Factors Affecting Wound Healing at the Systems Level
Progress through the biological stages of normal wound healing is reliant on a
number of interrelating factors from physiological, psychological and socioeconomic
systems. These factors directly or indirectly impact the normal healing pathways,
e.g. poor psychological health affects the functioning of the immune system, which
in turn disrupts the normal inflammatory response and growth factor production at
the wound site (Norman, 2003).
Physiological factors affecting wound healing
Physiological factors reported to influence the general wound healing process
include circulation, exercise, nutrition and the ageing process. The circulatory
system is required to provide an adequate flow of oxygen and nutrients to damaged
tissue and removal of toxic waste products for wound healing to occur (Patel, 2005).
Deficiencies in either the arterial supply or flow of venous return are known to result
in development of leg ulcers and impaired wound healing (Cullum et al., 2001b).
Exercise may be one method to improve circulation and Emery et al. (2005) found
significantly faster healing rates in artificially induced wounds in a sample of older
adults who commenced a program of exercise one month before the biopsy was
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taken [II]. The authors suggest the improved healing could be related to either
increased circulation and/or the benefits of exercise on the immune and endocrine
system. Further research is needed to determine the possible benefits of exercise
on wound healing, as this was a small randomised controlled trial restricted to
healthy older adults with an acute wound.
In contrast, the link between nutrition and wound healing has been frequently
discussed in the literature and tested in laboratory environments. Deficiencies in
Vitamin C and poor protein intake have been observed to be associated with wound
breakdown in the laboratory and clinical environment (Patel, 2005) and low serum
levels of zinc have been associated with delayed healing in hospitalised patients
(Wilkinson & Hawke, 1998a; Zorrilla et al., 2006). One study of residents with
chronic wounds in an aged care seting found participants with higher haemoglobin
levels were more likely to heal (Takahashi et al., 2009).
Unfortunately, although laboratory studies have shown that protein and vitamins
A, E, K and C are important in the wound healing process and deficiencies are
associated with delayed healing or wound breakdown, studies in the clinical
environment of nutritional supplements of proteins and/or vitamins have generally
shown no improvement in healing rates (Arnold & Barbul, 2006; Patel, 2005).
Similarly, although topical zinc pastes are a popular current treatment and have
been in use for skin problems for over 3,000 years (Patel, 2005), a Cochrane review
on the use of oral zinc supplements for patients with chronic wounds found little
evidence to support the use of oral zinc to improve wound healing in chronic leg
ulcers [ I ] (Wilkinson & Hawke, 1998b).
The ageing process affects many physiological activities and is implicated in
delayed wound healing. Studies have found ageing is associated with decreased
circulation to the skin and lymphatic drainage, slower immune responses and
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inflammatory response, reduced dermal thickness and slower rates of cell
proliferation, cell turnover and migration during the healing process (Enoch & Price,
2004; Gosain, 2004). In addition, advanced age is often associated with a number of
coexisting systemic diseases and multiple medications, many of which are likely to
impede wound healing. Complications related to ageing are particularly significant in
the study of chronic leg ulcers, with the average age of patients with leg ulcers
reported as around 75 years (Moffatt et al., 2006).
Psychosocial factors affecting wound healing
A number of psychosocial factors have been reported as important in the healing
process. Stress, depression and anxiety have been linked with delayed wound
healing and suppression or abnormal functioning of the immune system (Kiecolt-
Glaser & Glaser, 2002; Robles et al., 2005).
Reviews have found that stress or negative emotions can lead to prolonged
production of pro-inflammatory cytokines, which impact on the normal immune
response to infection and injury and cause disruption of wound healing processes,
including regulation and production of cytokines and growth factors (Kiecolt-Glaser
& Glaser, 2002; Norman, 2003; Robles et al., 2005). However, Norman (2003) notes
that the impact on immune system functioning has been reported mostly from
animal studies and further research is needed to determine the effects of
psychological factors on wound healing in real life situations.
A small number of studies have investigated the impact of stress, depression
and/or anxiety on wound healing in acute surgical or biopsy wounds in the hospital
environment. Cole-King and Harding (2001) and Doering et al. (2005) found a
significant association between patients with higher depressive symptom scores and
delayed wound healing (Doering et al., 2005) or higher Hospital Anxiety and
Depression Scale scores and impaired wound healing (Cole-King & Harding, 2001).
28
However, a smaller study by McGuire et al. (2006) found delayed healing was
significantly associated with the stressor of higher post-surgical pain scores, while
depressive symptoms had no effect on healing rates.
Closely tied to psychological influences are the effects of social stressors on
wound healing. The level of available social support is reported to be a factor in
mediating the effect of a stressor such as living with a chronic disease (Fisher &
Weihs, 2000; Gallant, 2003). Kiecolt-Glaser et al.’s (2002) review suggests the
presence of positive social support from close personal relationships may be one
method to prevent the disruptive impact of negative emotions on immune system
functioning. Laboratory studies have shown delayed wound healing in mice after
being separated from their mate and Kiecolt-Glaser et al.’s later (2005) research on
marital relationships and pro-inflammatory cytokines found decreased cytokine
production and delayed wound healing (in acute artificially inflicted wounds) after
marital conflict interactions in comparison to couples receiving a social support
intervention (Kiecolt-Glaser et al., 2005). Although there appears to be an absence
of studies examining the wound healing process in relation to socioeconomic
factors, low socioeconomic status is well known to be linked to poorer health and
Sapolsky (2005) points out that the poor generally have greater psychosocial
stressors and less social support available to deal with them. These factors are
likely to impact on immune system functioning and subsequently on wound healing,
although further research is required to support this argument.
29
Venous Leg Ulcers
Significance and Impact
Chronic leg ulcers are a world wide problem, with articles reporting estimates of
prevalence from the United Kingdom, France, Germany, Poland, Switzerland,
Slovakia, Italy, Spain, Portugal, Russia, Sweden, Denmark, the Netherlands, South
Africa, Tunisia, Saudi Arabia, Hong Kong, China, U.S.A., Canada and Brazil. The
majority (approximately 70%) of leg ulcers are venous (Nelson et al., 2000) and
affect approximately 1 – 3 % of the population aged over 60 years (Baker & Stacey,
1994; Briggs & Closs, 2003; Margolis et al., 2002). The long term nature of the
disease and extensive wound care requirements result in significant costs to health
care systems, estimated at approximately 1 - 2% of the total health care budget in
the UK and USA (Abbade & Lastoria, 2005; Anand et al., 2003). In addition to cost
of care, chronic leg ulcers are associated with prolonged ill health, decreased quality
of life, pain, restricted mobility, emotional distress and social isolation (Baker &
Stacey, 1994; Chase et al., 2000; Walshe, 1995).
Prevalence
Estimates of overall annual prevalence from Europe, the U.K. and Australia
range from 0.63% to 1.9% of the general population (Bergqvist et al., 1999; Briggs &
Closs, 2003; Graham et al., 2003; Johnson, 1995; Lees & Lambert, 1992; Margolis
et al., 2002); while point prevalence estimates range from 0.11% to 1.1% of the
general population (Adam et al., 2003; Baker & Stacey, 1994; Briggs & Closs, 2003;
Eberhardt & Raffetto, 2005; Graham et al., 2003; Lorimer et al., 2003a; Nelzen,
1997; Pina et al., 2005). However, prevalence is reported to increase sharply with
age (Adhikari et al., 2000; Baker & Stacey, 1994; Bergqvist et al., 1999; Clarke-
Moloney et al., 2006; Cullum et al., 2001b; Margolis et al., 2002; Moffatt et al., 2004;
O'Brien et al., 2000; Pina et al., 2005), so that estimates rise from around 0.6% of
30
the general adult population up to 2 – 5.6% of those aged over 65 years (Adam et
al., 2003; Araujo et al., 2003; Bergqvist et al., 1999; Lindholm et al., 1992). A study
of prevalence in Finland over a 20 year timeframe found the average patient age
had increased from 71 years to 75.7 years and an increasing prevalence of leg
ulcers over that time (Hjerppe et al., 2006).
Prevalence is slightly higher in females in comparison to males (Clarke-Moloney
et al., 2006; Johnson, 1995; Moffatt et al., 2004; O'Brien et al., 2000), but gender
differences even out as age rises (Moffatt et al., 2004). It has been suggested that
the prevalence is low in Asian populations (Carpentier & Priollet, 1994; Franks et al.,
1997) and Franks et al. (1997) found a significantly lower proportion of the Asian
population in an area of London required treatment for leg ulcers. However, Hobbs
et al.’s (2003) prospective study on a similar population found that although Asians
were less likely to present for treatment of chronic venous insufficiency, the ones
who did consult health professionals were younger with greater severity of illness,
suggesting they had a similar prevalence but were less likely to access general
health care services for the condition.
Cost
It has been estimated that developed countries spend approximately 1 – 2.5% of
total health costs on caring for chronic leg ulcers (Abbade & Lastoria, 2005; Anand
et al., 2003) and treatment in the U.S. costs over 3 billion $US and the loss of over 2
million workdays a year (McGuckin et al., 2002). Similarly, Harding quotes a cost of
£400 million each year in the U.K. (Harding et al., 2002). The cost to the Australian
health care system associated with chronic leg ulcers was reported to be $500
million/year in 1996 (Ramstadius, 1997). This cost is likely to rise significantly in the
future, as the incidence of leg ulcers increases with age and the mean age of
Australians is progressively rising (Australian Institute of Health & Welfare, 2002). In
31
addition to the substantial costs associated with months or years of purchasing
wound dressings and compression bandages, it is reported that up to 22 – 70% of
community nurses’ time is spent managing the problem (Hampton, 2003; Simon et
al., 2004). Flaherty (2005a) estimated that if time between healing and recurrence
was extended by even one month, community nursing time on chronic leg ulcers
would drop by 8%.
Chronic leg ulcers are associated with significant hidden financial burdens on the
community along with the direct costs to the health care system. The condition
contributes to significant levels of depression, anxiety and social isolation (Baker &
Stacey, 1994; Persoon et al., 2004; Simon et al., 2004). The pain, ill-health and
extensive bandaging associated with the condition commonly result in loss of
mobility, decreased ability to attend to activities of daily living and loss of
participation in the workforce and society (Husband, 2001; Wissing et al., 2002). An
Australian study, for example, found 45% of patients with leg ulcers were completely
housebound (Baker & Stacey, 1994). Additional costs are thus associated with lost
productivity, provision of social support systems necessary for people with limited
mobility and health complications resulting from prolonged immobility.
Pain
Chronic leg ulcers are associated with significant levels of pain (Brown, 2005a;
Edwards, 2003; Husband, 2001; Nemeth et al., 2003; Ryan et al., 2003). Prevalence
of pain is reported as ranging from 48 – 54% (Nemeth et al., 2003) up to
approximately 81% (Edwards et al., 2005b; Hareendran, 2005) of patients.
Moderate to severe pain is reported as experienced by 19% (Chase et al., 2000) to
46% (Edwards et al., 2005b) of patients; with as many as 17 – 65% of people with
venous leg ulcers reporting severe or continuous pain (Briggs & Nelson, 2003).
Although a number of pain relieving interventions for use during wound debridement
32
have been evaluated (Agrifoglio et al., 2000; Lok et al., 1999; Rosenthal et al.,
2001), a systematic review found no studies addressing the persistent pain in
people with venous leg ulcers between dressing changes (Briggs & Nelson, 2003).
A number of literature reviews have found pain is identified as one of the major
limitations on quality of life and lifestyle of sufferers of leg ulcers and frequently
appears to be inadequately managed (Heinen et al., 2004; Herber et al., 2007;
Nemeth et al., 2003; Persoon et al., 2004; Wilson, 2004). Leg ulcer pain is reported
to decrease energy levels (Ebbeskog & Ekman, 2001; Persoon et al., 2004),
interrupt sleep (Ebbeskog & Ekman, 2001; Edwards et al., 2005b), affect mood
(Edwards et al., 2005b), decrease quality of life (Guarnera et al., 2007), restrict
mobility (Brown, 2005b; Chase et al., 2000) and socialisation (Baker & Stacey,
1994; Ebbeskog & Ekman, 2001; Walshe, 1995), and decrease ability to manage
normal daily work or activities (Ebbeskog & Ekman, 2001; Edwards et al., 2005b;
Heinen et al., 2004).
Oedema, eczema and exudate
In addition to pain, venous ulcers are associated with a number of symptoms
resulting from chronic venous insufficiency which may cause extreme discomfort
and irritation. These include continual itching, scaling and inflammation of the skin in
the lower limbs associated with venous eczema (Hareendran, 2005) and the
discomfort and inconvenience of lower leg oedema associated with venous
hypertension (Brown, 2005b). The excess fluid in oedematous legs often results in
drainage of large amounts of exudate from venous ulcers, resulting in further
discomfort from wet bandages (Edwards, 2003) and embarrassment associated with
leakage and odour (Baker & Stacey, 1994; Hyde et al., 1999). Jones et al. (2008)
found odour and excessive exudates led to feelings of disgust, self-loathing and low
self-esteem.
33
Reduced mobility and impaired functional ability
As a result of pain, oedematous legs and the need to wear bulky, multi-layered
bandages, patients with chronic leg ulcers frequently report restricted mobility and
impaired ability to manage normal daily activities and work (Abbade & Lastoria,
2005; Brown, 2005b; Hareendran, 2005; Heinen et al., 2007a; Herber et al., 2007;
Persoon et al., 2004; Wissing et al., 2002). It is estimated that as many as half of all
patients with leg ulcers suffer moderate to severe restrictions in mobility, with Baker
and Stacey (1994) reporting 45% of patients completely housebound due to their
ulcers. Similarly, 54% (Lorimer et al., 2003a) to 61% (Edwards et al., 2005a) of
patients with leg ulcers are reported to require physical aids or assistance for
mobility, and 57% of Brem et al.’s (2004) sample reported severe limitations to
mobility.
The restrictions to mobility impact on independence in activities of daily living and
productivity. Abbade et al. (2005) found 49.2% of patients had a functional disability
impacting on daily activities and work and Persoon et al.’s (2004) review of 37
studies reported restraints in work and leisure activities as one of the major
limitations imposed by leg ulcers. Chase (2000), Hyland, Ley and Thomson (1994),
Phillips et al. (1994) and Hareendran (2005) also report moderate to severe
limitations in functional ability and productivity.
One small study investigated reasons for low levels of physical activity and found
limited knowledge, low self-efficacy and social support influenced participants’ levels
of activity in addition to their pain and multi-morbiditiy (Heinen et al., 2007b).
Interestingly, voluntary restrictions in activities even after ulcer healing has occurred
have also been reported, as patients are wary of exposing their legs to the risk of
trauma and the possibility of initiating a new ulcer, therefore avoiding shopping,
34
crowded places or being around children or animals (Brown, 2005b; Hyland et al.,
1994).
Social isolation
The pain, limited mobility and embarrassment of exudate leakage associated with
leg ulcers often leads to social isolation (Ebbeskog & Ekman, 2001; Herber et al.,
2007; Persoon et al., 2004; Walshe, 1995). Moffatt et al. (2006) found 37% of leg
ulcer patients were housebound, and an Australian study reported 45% of patients
were completely housebound (Baker & Stacey, 1994). Brown’s (2005b)
phenomenological study found participants described social disconnectedness and
isolation as a result of restricted mobility and fear of damaging their legs. Younger
working patients describe lost work time, loss of employment and financial problems
(Chase et al., 1997; Phillips et al., 1994), also contributing to limitations in their usual
social activities.
Psychological impact
The combination of pain, restricted mobility, social isolation and chronicity of the
disease contributes to negative impacts on psychological health (Ebbeskog &
Ekman, 2001; Herber et al., 2007; Jones et al., 2006; Persoon et al., 2004).
Psychological effects have been reported in 27% (Jones et al., 2006), 33% (Hyland
et al., 1994), 67% (Hareendran, 2005) and 68% (Phillips et al., 1994) of patents with
chronic leg ulcers and encompass negative emotions (Ebbeskog & Ekman, 2001;
Phillips et al., 1994), sleep disturbances (Hareendran, 2005; Persoon et al., 2004),
worries and frustrations (Chase et al., 1997; Persoon et al., 2004; Phillips et al.,
1994), cognition (Wissing et al., 2002) and depression and anxiety (Jones et al.,
2006; Phillips et al., 1994). The nature of the condition i.e. large, long-lasting
weeping wounds, can also result in problems with body image (Chase et al., 1997;
Ebbeskog & Ekman, 2001; Phillips et al., 1994) or altered appearance (Hareendran,
35
2005; Hyde et al., 1999) and embarrassment (Hyde et al., 1999; Hyland et al.,
1994). As many ulcers take years to heal, followed by recurrence shortly after, the
long term nature of the disease can lead to uncertainty, disappointment, loss of
hope, or despair (Chase et al., 1997; Ebbeskog & Ekman, 2001; Hareendran, 2005).
Chase et al. (Chase et al., 2000; 1997) have also reported problems with poor
understanding of the cause and treatment of the condition, leading to feelings of
powerlessness, lack of ownership and apathy with regard to management
strategies.
Decreased quality of life
Measures of quality of life in patients with chronic leg ulcers have generally found
significantly lower quality of life scores than in the general population (Andreozzi et
al., 2005; Brem et al., 2004; Franks et al., 2003; Jull et al., 2004b; Persoon et al.,
2004; Wissing et al., 2002). Using the Medical Outcomes Study SF36, Franks et al.
(2003) found significantly lower scores in the role-emotional domain, social
functioning, role-functioning, role-physical and pain domains than normative scores,
while Jull et al. (2004b) found significantly lower scores across all eight domains of
the survey than both a control group and normative scores. Quality of life scores
tend to improve significantly following compression treatment (Andreozzi et al.,
2005; Franks & Moffatt, 2001) and healing (Franks et al., 2003; Franks & Moffatt,
2001) and worsen in patients with multiple comorbidities (Schmidt et al., 2000), a
lack of social support (Schmidt et al., 2000), pain and non-healing ulcers
(Hareendran, 2005).
36
Aetiology and Risk Factors
Aetiology of venous leg ulcers
The majority of chronic leg ulcers are caused by venous pathophysiology, with
rates of ulcers with a pure venous origin reported as ranging from 43 – 87%
(Abbade & Lastoria, 2005; Adam et al., 2003; Araujo et al., 2003; Briggs & Closs,
2003; Clarke-Moloney et al., 2008; Fassiadis et al., 2002b; Iglesias et al., 2004;
Klode et al., 2009; McGuckin et al., 2002; Moffatt et al., 2004; Nemeth et al., 2003;
Pina et al., 2005; Rayner, 2007; Shai & Halevy, 2005). Ten to nineteen percent are
reported to have a mixed venous and arterial cause (Adam et al., 2003; Bergqvist et
al., 1999; Klode et al., 2009; Musgrove et al., 1998; Naik et al., 2000; Pina et al.,
2005), 6% from diabetes (Bergqvist et al., 1999) and 2 – 16% from arterial aetiology
(Klode et al., 2009; Moffatt et al., 2004; Musgrove et al., 1998; Naik et al., 2000;
O'Brien et al., 2000; Pina et al., 2005; Rayner, 2007).
The physiological aetiology of venous leg ulcers has not yet been fully
determined, but the condition commonly arises following a failure in the venous
return mechanisms in the lower limbs, either due to faulty valves or trauma in the
vessels (eg. post deep vein thrombosis) or genetic weakness. Venous reflux occurs
in the damaged veins, leading to a sustained increase in pressure in the venous
system in the lower limb (venous hypertension), causing capillary dilation and
leakage of plasma, proteins, white blood cells and red blood cells into the
surrounding tissues (Angle & Bergan, 1997; Brem et al., 2004).
The precise links between venous hypertension and the development of ulcers
are still unknown (Faler et al., 2006). Theories for the subsequent development of
leg ulcers include the Fibrin Cuff Theory, where it is suggested that the leakage of
fibrin into the tissues forms a cuff around the dermal capillaries, obstructing the
blood flow of oxygen and nutrients into the skin (Elder & Greer, 1995); and the
37
Leucocyte Trap Theory, which suggests that the trapped leucocytes release
inflammatory substances which damage the local tissue and trap growth factors and
cytokines necessary for normal wound healing (Angle & Bergan, 1997; Brem et al.,
2004). It is suggested that prolonged venous hypertension causes leucocyte
activation, which itself damages the vessel endothelium and leads to chronic local
tissue inflammation (Smith, 2006). Compression therapy aims to improve the
impaired venous return, restore normal vascular function and reduce the venous
hypertension and capillary leakage which leads to ulcer formation (Coleridge Smith,
2002). Venous leg ulcers are often slow to heal and indicators of a prolonged
inflammatory state leading to alteration of normal healing processes have been
found in analysis of tissue samples (Harding et al., 2005), such as prolonged
expression of matrix matalloproteinases (Beidler & Et al., 2008; Moor et al., 2009)
and degradation of fibronectin (Moor et al., 2009).
The problem may occur in the superficial veins of the lower leg, deep veins,
perforating veins or a combination of all. Patients with only superficial venous
incompetence are more likely to have a better prognosis for healing (Bjellerup &
Akesson, 2002). It is reported that approximately 43 – 53% of venous incompetence
is superficial only (Adam et al., 2003; Barwell et al., 2004; Bergqvist et al., 1999;
Ghauri et al., 1998a; Magnusson et al., 2001; Naik et al., 2000), 13 – 53% have
mixed incompetence (Adam et al., 2003; Barwell et al., 2004; Bergqvist et al., 1999;
Danielsson et al., 2004; Magnusson et al., 2001) and 4 – 47% are reported with
deep venous incompetence (Adam et al., 2003; Barwell et al., 2004; Danielsson et
al., 2004; Magnusson et al., 2001; Naik et al., 2000).
Risk factors for venous leg ulcers
A number of risk factors are known to be associated with the development of
chronic venous insufficiency and venous leg ulcers. These include conditions which
38
place extra stress on the venous system, such as obesity (Abbade et al., 2005;
Adhikari et al., 2000; Danielsson, 2003; Ganov et al., 2006; Jawien, 2003;
Robertson et al., 2009), multiple pregnancies (Abbade et al., 2005; Berard et al.,
2002; Ganov et al., 2006; Jawien, 2003), activities requiring prolonged periods
standing or sitting (Adhikari et al., 2000; Bawakid et al., 2005; Fowkes et al., 2001;
Ganov et al., 2006; Jawien, 2003; Nelzén et al., 1991), vigorous strenuous exercise
or labour (Berard et al., 2002; Ganov et al., 2006); and conditions resulting in an
impaired venous system, such as a deep vein thrombosis (Berard et al., 2002;
Bergqvist et al., 1999; Robertson et al., 2009; Walker et al., 2003), trauma (Walker
et al., 2003), or a family history of varicose veins (Abbade & Lastoria, 2005; Adhikari
et al., 2000; Bawakid et al., 2005; Bergqvist et al., 1999; Fowkes et al., 2001;
Jawien, 2003). Impaired mobility has also been associated with an increased risk of
leg ulcers (Dix et al., 2003; Moffatt et al., 2006; Robertson et al., 2009). Other risk
factors include age (Adhikari et al., 2000; Bawakid et al., 2005; Fowkes et al., 2001;
Gohel et al., 2005b; Jawien, 2003; Naik et al., 2000); race (Danielsson et al., 2002;
Moffatt et al., 2006) and gender, with a slightly higher prevalence recorded in
females (Adhikari et al., 2000; Moffatt et al., 2006; Naik et al., 2000; O'Brien et al.,
2000).
Social class has been suggested as a risk factor, although Nelzen (1997) and
Callam et al. (1988) with a sample of 600 patients found no higher risk present for
ulceration dependent on social class. However, Abbade et al. (2005) reported that
90% of a sample of patients with venous leg ulcers were living on or below the
poverty line; and Bergzvist et al. (1999) found a sample of 78 patients with venous
leg ulcers had a significantly lower income than a control group of 270. Moffatt et al.
(2006) also recently found a significantly increased risk of leg ulcers associated with
the lower social classes and renting, in addition to a link between poor social
support and an increased risk of leg ulcers.
39
Healing Venous Leg Ulcers
The healing process in venous leg ulcers is typically one of long duration,
although considerable variation in healing rates have been described. Researchers
have reported median ulcer durations ranging from six months (Lorimer et al.,
2003a), eight months (Moffatt et al., 2006), 11 months (Edwards et al., 2005b) up to
64 months (Abbade et al., 2005).
Healing rates are reported as ranging from:
• 12% (Ghauri et al., 1998b), 47% (Ghauri et al., 2000), 23-56% (Harrison et
al., 2005), 34-54% (O'Brien et al., 2003), 64% (Vowden et al., 1997) and
69% (Franks et al., 1995b) healed after 12 weeks of treatment;
• After six months of treatment: 29% (Ghauri et al., 1998b), 53% (Salaman &
Harding, 1995), 68% (Ghauri et al., 1998b), 72 – 74% (Barwell et al., 2000b),
75% (Guest et al., 1999; Musgrove et al., 1998), 76% (Gohel et al., 2005b),
83% (Franks et al., 1995b) and 84% (Vowden et al., 1997) healed; to
• 55% (Bello et al., 2000; Scriven et al., 1998), 64% (Bitsch et al., 2005), 73%
(Bello et al., 2000) up to 88% (Scriven et al., 1998) healed at twelve months.
A number of factors have been identified as influencing progress in healing in
venous leg ulcers. As with general wound healing, these can be grouped under
physiological, psychological, political and socio-economic issues.
Physiological factors affecting healing in venous leg ulcers
Age
Advancing age has been identified as a risk factor associated with slower healing
rates in leg ulcers (Barwell et al., 2000a; Gibson, 2007; Meaume et al., 2005; Taylor
40
et al., 2002; Wicke et al., 2009). This has been supported by a large study with
1,186 patients where Gohel et al. (2005b) found age was a significant independent
risk factor for delayed ulcer healing.
Nutrition
The effect of nutritional deficiencies on healing in chronic leg ulcers is relatively
unknown, although it has been observed that this population is likely to be at high
risk of malnutrition due to their age, restricted mobility and requirements for help to
shop and prepare food (Gerry & Edwards, 2003; Heinen et al., 2004; Wipke-Tevis &
Stotts, 1998). In addition, the extra nutritional demands for wound healing and loss
of nutrients via wound exudate further suggest a possible risk of inadequate nutrition
(Demling, 2000; Flanagan & Fletcher, 1997). Significant relationships have been
identified between both a low BMI and poor healing (Collins et al., 2005), and a high
BMI and the risk of delayed healing in venous leg ulcers (Meaume et al., 2005; Milic
et al., 2009b; Taylor et al., 2002), suggesting the need for further investigation into
the possibility of poor nutritional status in this group.
Wissing and Unosson (1999) and Szewczyk et al. (Szewczyk et al., 2008) found
patients with leg ulcers were at higher risk of scoring at-risk of malnutrition or being
malnourished, while Rojas and Phillips (1999) and Toban et al. (Toban et al., 2008)
found patients with leg ulcers had significantly lower vitamin A, protein and/or zinc
levels. However, there are mixed findings on relationships between nutrition and
progress in wound healing. No relationships were found between the nutritional
status of patients, the duration of leg ulcers and/or healing rates by Wissing &
Unossan (1999) and Wipke-Tevis and Stotts (1998). In contrast, a prospective study
found protein deficiency was associated with poor healing (Legendre et al., 2008).
Zinc has been implicated as important in wound healing in laboratory studies
(Arnold & Barbul, 2006; Patel, 2005) and a small number of trials of oral zinc
41
supplements for patients with chronic leg ulcers have been undertaken. However, a
systematic review of these trials found no significant benefit from the supplements
for healing leg ulcers [ I ] (Wilkinson & Hawke, 1998b), and a later review in 2003
found no new evidence supporting its use [ I ] (Gray, 2003). Gray’s (2003) review of
vitamin A or vitamin E supplements on ulcer healing also found no experimental or
quasi-experimental studies to provide any evidence of benefit [III]. Similarly, a study
of two differing nutritional supplements found no difference in wound healing rates
(Collins et al., 2005).
Ulcer size, duration and aetiology
Both ulcer size and duration have been identified as risk factors for delayed
healing. In general, the larger the ulcer, the more delayed the healing process, as
reported in a large number of studies (Chaby et al., 2006a; Franks et al., 1995b;
Guest et al., 1999; Iglesias et al., 2004; Margolis et al., 2004; Meaume et al., 2005;
Phillips et al., 2000; Stacey et al., 1997; Taylor et al., 2002; Vowden et al., 1997). An
ulcer size of over 10 cm2 has been recognised as being at significantly greater risk
of delayed healing (Franks et al., 1995b; Margolis et al., 2004; Meaume et al.,
2005).
Significant associations between the duration of the ulcer and likelihood of
healing have also been found by a number of researchers (Barwell et al., 2000a;
Chaby et al., 2006a; Gohel et al., 2005b; Margolis et al., 2004; Meaume et al., 2005;
Moffatt et al., 2010; Phillips et al., 2000; Ukat et al., 2003). Meaume et al. (2005)
specified an ulcer duration over three months as associated with prolonged healing;
Franks et al. (1995b) found a duration over six months was inversely associated
with healing and Margolis et al. (2004) reported that ulcers over 10cm2 in size and
lasting over 12 months had a 78% chance of not healing after 24 weeks of
treatment. In addition, specific aetiological factors, such as the presence of deep
42
vein insufficiency (Barwell et al., 2000a), arterial involvement (Chaby et al., 2006a;
Margolis et al., 1999), a history of venous surgery (Margolis et al., 1999), or a history
of a deep vein thrombosis (Chaby et al., 2006a; Guest et al., 1999; Moffatt et al.,
2010) have been associated with delayed ulcer healing.
Mobility and exercise
Restricted mobility is seen as both an outcome of chronic ulceration and as a
possible contributor to delayed ulcer healing. Disability, poor calf muscle pump
function or poor mobility in general has been reported as a significant risk factor for
delayed healing by Chaby et al. (2006a), Simka (2007), Franks et al. (1995b) and
Vowden (1997); poor limb joint mobility by Franks et al. (1995b); and poor ankle
mobility as a significant risk factor by Barwell et al. (2001), Iglasius et al. (2004) and
Milic et al. (2009b). However, in a study of patients with current leg ulceration,
Clarke-Moloney et al. (2007) found the amount of time spent mobilising or resting
did not influence ulcer healing [IV].
Physiological and histology studies have found the presence of venous
insufficiency and subsequent venous hypertension may lead to calf muscle changes
such as muscle fibre atrophy (Qiao et al., 2005), abnormal gait (Brem et al., 2004;
Van Uden et al., 2005), and reduced strength and functioning of the calf muscle
(Brem et al., 2004; Orsted et al., 2001; Qiao et al., 2005; Van Uden et al., 2005;
Yang et al., 1999a). Brem (2004) suggests that walking with a painful ulcer may
cause change in gait, leading to calf muscle atrophy from disuse.
In light of these findings, it has been suggested that exercise programs
concentrating on strengthening calf muscle and improving venous return may
improve healing rates, maintain ankle flexibility and prevent the development of
venous ulcers (Brem et al., 2004; Steins & Junger, 2000). Limited studies have been
reported in this area. One small study examining changes in venous function
43
following an exercise program found conflicting results on venous volume and
venous filling indexes in patients with venous insufficiency (Zajkowski et al., 2006).
Yang, Vandongen and Stacey (1999b) and Padberg, Johnston and Sisto (2004)
evaluated exercise programs in small groups of patients with venous insufficiency
and both studies found significant improvements in calf muscle pump function,
although the level of reflux or venous insufficiency severity was not changed in
either study [III-3, Yang et al.], [II, Padberg et al.]. However, neither study included
patients with active ulcers to measure effect on healing or measured recurrence
rates.
Compression therapy
A systematic review in 2009 found compression therapy significantly improved
healing rates of venous leg ulcers, the use of multilayered high compression
systems is more effective than single layered low compression systems, and
multilayered systems including an elastic component were more effective than non-
elastic [ I ] (O'Meara et al., 2009b). Multilayered compression systems are reported
to heal up to 88% of patients (Moffatt et al., 2003) after 6 months of treatment [II].
O’Brien (2003) obtained a 54% healing rate at 3 months in patients receiving a 4
layer compression system, in comparison to 34% healed in a control group receiving
‘usual care’, where only 5 of 100 participants received some kind of compression [II].
Debate exists on the optimal type and level of compression systems, and multiple
trials comparing various systems have been undertaken with conflicting results.
McGuckin et al. (2001) [III-3], Scriven et al. (1998) [II], Franks et al. (2004) [II],
Iglasius et al. (2004) [II], and Partsch et al. (2001) [II] found no difference in healing
rates between participants treated with short stretch systems compared to those in
multi-layered long stretch systems. However, Ukat et al. (2003) [II] found patients in
a 4 layer system healed significantly faster than those in a short stretch system and
44
Nelson et al. (2004) reported that after adjusting for risk factors, regression analysis
found patients in a short stretch system were less likely to heal as quickly as those
in a four layer long stretch system [II]. A recent meta-analysis and systematic review
confirmed that patients in a four layer system were likely to heal more rapidly
(O'Meara, 2009; O'Meara et al., 2009a) [ I ].
Comparisons of other systems are less frequently reported. Moffatt et al. (2003)
found patients randomised to a 4 layer long stretch system had improved healing
rates at 12 weeks in comparison to those in a 2 layer long stretch system, although
the differences were non-significant by 24 weeks [II]. Another comparison with a
newer two layer system and a 4 layer system found no differences in healing rates
between the systems (Moffatt & et al., 2008) [II]. Higher healing rates have been
reported from compression hosiery in comparison to short stretch compression
systems [ I ] (O'Meara et al., 2009b), while Polignano et al. (2004) found no
difference in healing rates between a 4 layer system and the Unna’s Boot system,
although the 4 layer was found easier to apply [II]. Further investigation is required
to determine the optimal types and level of compression systems to promote ulcer
healing.
Leg elevation
Patients are frequently advised to rest with legs elevated to improve their venous
return and reduce complications of venous insufficiency. However, there appears to
be little evidence supporting this advice. One small study has examined the
frequency and effect of leg elevation in patients with venous leg ulcers, and found
that although posture changes improved venous flow and reduced venous
pressures, median leg elevation time was measured at only 53 minutes per day in
the sample and there was poor correlation between ulcer healing and leg elevation
[IV] (Dix et al., 2005). Heinen et al.’s (2004) review of interventions for venous leg
45
ulcer patients found some evidence that elevation during bed rest may improve
circulation in the area, but no studies have measured the effect of elevation on
healing.
Surgery
Superficial venous surgery in patients with superficial insufficiency has not been
found to improve ulcer healing rates in comparison to compression therapy alone [II]
(Barwell et al., 2004; Barwell et al., 2000b; Gohel, 2007; Guest et al., 2003),
although reduced rates of recurrence have been reported [II] (Barwell et al., 2004;
Gohel, 2007). Evaluations of surgical techniques to improve deep vein
incompetence have been reported (eg. (Hardy et al., 2004b; Lane et al., 2003;
Tripathi et al., 2004), but a Cochrane review (Hardy et al., 2004c) found only a few
small trials and concluded there was insufficient evidence to recommend the
treatment at present [ I ]. A systematic review of skin grafts for venous leg ulcers
also found difficulties in making a conclusion, although two trials indicated that a
bilayer artificial skin used in conjunction with compression bandaging increased the
chance of healing [ I ] (Jones & Nelson, 2007). A more recent study also found
inclusive results [III] (Jankunas et al., 2007). Regular surgical debridement has been
reported as promoting improved healing outcomes [III] (Cardinal et al., 2009).
Wound dressing
Despite the many recent advances in wound dressing technology, healing of
venous leg ulcers has not yet been shown to improve with any one type of wound
dressing. A large number of trials have compared different wound dressings and
found no difference in healing rates (Andersen et al., 2002; Bale, 1998; Charles et
al., 2002; Franks et al., 2007; Jull et al., 2008a; Moffatt et al., 1992); and two
systematic reviews of effectiveness of dressings for healing venous leg ulcers have
found no differences between dressing type in terms of healing rates, reduction in
46
wound size [ I ] (Bouza et al., 2005) or numbers of ulcers healed [ I ] (Palfreyman et
al., 2006). One randomised trial restricted to venous leg ulcers with over 50%
sloughy surface area found that use of Manuka honey improved healing rates [II]
(Gethin & Cowman, 2009), however a systematic review of honey found it did not
increase healing time [ I ] (Jull et al., 2008b). An analysis of two studies found some
evidence that cadexomer iodine was associated with improved healing [II] (O'Meara
et al., 2008). Silver dressings are frequently prescribed at the current time, however,
a recent randomised controlled trial [II] (Michaels et al., 2009) and an earlier
systematic review have found no evidence to support their use [ I ] (Chambers et al.,
2007).
Additional therapies
Other therapies which have been evaluated for their impact on healing venous
leg ulcers include intermittent pneumatic compression pumps, hyperbaric oxygen
therapy, growth factors, dermal replacements, larval therapy, laser therapy,
therapeutic ultrasound, electrotherapy, electromagnetic therapy, negative topical
pressure and the use of phlebotonic drugs. Unfortunately, there is very little
evidence to support most of these treatments.
A Cochrane systematic review of intermittent pneumatic compression in 2008
found inadequate evidence of effectiveness in healing [ I ] (Nelson et al., 2008), in
agreement with an earlier review in 2003 [ I ] (Berliner et al., 2003). However,
Rowland’s (2000) study found that although there was no difference in healing rates
between use of a compression pump or compression bandaging [II], patients found
the compression pump easier to use, which may improve compliance rates in the
future.
A systematic review of hyperbaric oxygen therapy found only one study with
patients with venous leg ulcers with no improvement in healing rates [II] (Gray &
47
Ratliff, 2006; Roeckl-Wiedmann et al., 2005). Similarly, reviews of laser therapy,
therapeutic ultrasound, larval therapy and electrotherapy have not found sufficient
evidence of benefit in healing venous ulcers [ I ] (Al Kurdi et al., 2008; Cullum et al.,
2001a; Dumville et al., 2009; Ravaghi et al., 2006). A more recent trial of electrical
stimulation confirmed those findings with no difference in healing rates [ II ] (Junger
et al., 2008). However, a recent systematic review of electromagnetic therapy found
some evidence for its effectiveness in healing [ I ] (McGaughey et al., 2009). One
study of vacuum-assisted closure also found a faster time to healing [II] (Vuerstaek
et al., 2006).
Laboratory studies suggest the application of various types of growth factors and
dermal replacements may promote healing, but clinical studies have generally not
shown any benefit in healing (Akopian et al., 2006). Reviews on the use of drugs to
improve chronic venous insufficiency have conflicting results. A randomised trial of
use of mesoglycan [ II ] (Arosio et al., 2001) and a meta-analysis of use of
micronized purified flavonoid fraction [ I ] (Coleridge-Smith et al., 2005) found they
both accelerated healing in conjunction with compression therapy. However, a
Cochrane systematic review on phlebotonic drugs in 2005 concluded there was
insufficient evidence to support their effectiveness for venous insufficiency (Martinez
et al., 2005). A systematic review evaluating only pentoxifylline concluded that
pentoxifylline was more effective than a placebo [ I ] (Jull et al., 2007).
Psychological factors affecting healing in venous leg ulcers
Although depression and anxiety have been shown to delay acute wound healing
(Cole-King & Harding, 2001; Doering et al., 2005), there is an absence of research
on the relationship between poor mental health and healing in venous leg ulcers.
Despite this lack of research, the findings from some studies in patients with venous
leg ulcers suggest that depression may contribute to poor healing rates. It is known
48
that a significant number of patients with leg ulcers have problems with depression
and anxiety. Chase et al. (1997), Hareendran (2005), Jones et al. (2006), Persoon
et al. (2004) and Yamada and de Gouveia Santos (2005) found significant
correlations between patients’ psychological and spiritual well being and the number
of venous ulcers experienced. Moffett et al. (2009a) found patients with leg ulcers
were more likely to be depressed and have less social networks than matched
controls without leg ulcers. Wong and Lee (2008) found there was a signifiant
correlation beween patients with better emotional status and a higher likelihood of
healing.
Patients with chronic leg ulcers have also indicated that depression is a barrier to
self care behaviours (eg. wearing compression garments or bandages) aimed at
healing the ulcers (Nelson, 2005) and a review of studies on concordance with
compression therapy found aesthetic factors may play a role (Moffatt et al., 2009b).
Difficulties with patients’ knowledge of their leg ulcers and treatments have been
reported (Brown, 2005b; Edwards et al., 2002; Moffatt et al., 2009b). Similarly, Jull
et al. (2004a) noted that the belief that wearing compression was worthwhile was
related to adherence to wearing compression. Edwards et al. (2002) surveyed 101
patients with chronic venous leg ulcers and found the majority of patients’
understanding of the condition was poor. This was also demonstrated in a
hermeneutic study which described a lack of understanding, leading to
disempowerment, apathy and poor concordance with treatment regimes (Chase et
al., 2000; Edwards, 2003).
Political and socio-economic factors affecting healing in venous leg ulcers
Socio-economic factors
It has been reported that patients with leg ulcers are more likely to come from the
lower socioeconomic classes (Abbade et al., 2005; Franks et al., 1995a; Moffatt et
49
al., 2006). However Callum et al. (1988) studied 600 patients and found no
difference in incidence of leg ulcers, but rather the leg ulcers in this group were
more likely to be recurrent and take longer to heal. Franks et al. (1995a) found
significant associations between ulcer healing and social class, central heating and
being male and single, although only central heating remained significant when
controlling for other factors. Similarly, although not looking at healing rates, Moffatt
et al.’s (2006) recent study supported findings of significant associations between
the presence of leg ulcers and lower social class, living in rented housing, being
single and poorer levels of social support. Further investigation in this area is
required to determine the impact of social class and social support on healing in
chronic leg ulcers.
Health care systems and policies
Although health care for chronic leg ulcers has traditionally taken place via
individual visits to the GP or community nurse visits to each patient’s home,
significantly higher healing rates have been reported when health care for patients
with venous leg ulcers has been organised in dedicated leg ulcer clinics (Ghauri et
al., 2000; Morrell, 1998; Oien & Ragnarson Tennvall, 2006; Simon et al., 1996).
Comparisons of healing rates between leg ulcer clinic patients and control groups
include 42% healed following the introduction of a community leg ulcer clinic in
comparison to 20% in a control area [III-2] (Simon et al., 1996); 34% of clinic
patients healed by 12 weeks in comparison to 24% in a control group [II] (Morrell,
1998); 56% healed at 12 weeks after the introduction of a dedicated service in
comparison to 23% healed before the service commenced [III-3] (Harrison et al.,
2005); and 47% healed at 12 weeks after the introduction of a specialised leg ulcer
service compared to 12% prior to the new clinic [III-2] (Ghauri et al., 2000). There
are difficulties interpreting these results, as the studies above have either not been
randomised, or the groups being compared in the studies have not received the
50
same treatment (e.g. four layer compression bandaging by an experienced clinician
in a clinic versus a variety of ‘usual care’ treatments in the home).
Debate exists on whether the improved healing rates are due to the provision of
consistent care by specialist health professionals and improved access to
appropriate treatments within these clinics, or whether the same results could be
achieved by simply following consistent, evidence based guidelines and treatments
whether in a clinic or in the home. Inconsistent treatment for chronic leg ulcers is a
well reported problem. Researchers have noted that health care services for leg
ulcer patients are spread over multiple settings, with multiple providers, and are
often poorly coordinated (Flanagan et al., 2001; Harrison et al., 2005). Gaps
between evidence for care of leg ulcers and actual care provided have been
reported by Lorimer et al. (2003b), McIassac (2005), McMullen (2001), Sadler et al.
(2006), Moffatt and Franks (2004), Woodward (2002) and Coyer (Coyer et al.,
2005). As a consequence, surveys have found an amazing range of treatments,
such as 28 different dressings used on 35 ulcers (Ribu et al., 2003), 35 different
types of dressings in a study by Lees and Lambert (1992), and 136 different
treatments found in a study of 241 patients with venous leg ulcers (Walker et al.,
2002).
McGuckin et al. (2002) argue that experienced, well trained district nurses
following consistent treatment guidelines can obtain equally good healing rates
without investing in the resources needed to set up a community clinic and reported
results of 65% healed at 12 weeks following introduction of guidelines, from 40%
healed prior to guideline introduction [III-3]. Similarly, Harrison et al. (2008) found no
difference in healing rates when patients were cared for by trained staff providing
consistent evidence based care, whether in the home or in a clinic [II]. Evaluations
of ulcer care following the introduction of evidence based guidelines and education
on assessment and appropriate treatment have reported increases in appropriate
51
assessment [III-3] (Moffatt & Franks, 2004), increased use of compression
bandaging [III-3 – IV] (Clarke-Moloney et al., 2008; McGuckin et al., 2001; Moffatt &
Franks, 2004), improved healing rates [III-3 – IV] (McGuckin et al., 2001; Moffatt &
Franks, 2004; Olson et al., 2009) and improved quality of life measures [III-3]
(Moffatt & Franks, 2004). Phillips et al. (2000) also demonstrated that consistent
treatment with a clearly defined system of care was associated with a high
percentage (55%) of healing in large ulcers of long duration [III-3]. However, a large
randomised trial to evaluate an education program associated with the introduction
of the Scottish Intercollegiate Guidelines for patients with leg ulcers for community
nurses providing home care for leg ulcers found no differences between healing
rates at baseline to healing rates in the following two years after the intervention, or
between areas where nurses had received the training and the control areas [III-1]
(Brown et al., 2002). In addition, a randomised controlled trial by Edwards et al.
(2005b) compared groups receiving the same evidence based treatment protocols
either in the home or in a community Leg Club environment, and found improved
healing rates of 64% in the group environment in comparison to 40% of patients in
the home environment [II]. This study suggests a group environment may have
advantages other than just the provision of consistent, evidence based care.
Evaluations of community leg ulcer clinics have identified a number of important
benefits apart from improvements in healing rates. The clinics provide social
benefits, peer support and empathy (Chaloner & Noirit, 1997; Lindsay, 2000; Russell
& Bowles, 1992). Improvements in quality of life, enthusiasm and motivation for
treatment, increased knowledge and understanding, improved self-esteem,
decreased depression, decreased anxiety and hostility and a reduction in pain have
also been reported (Chaloner & Noirit, 1997; Dorman et al., 1995; Edwards et al.,
2009; Franks & Moffatt, 2006; Franks et al., 1994; Lindsay, 2000). Some authors
have noted that community leg ulcer clinics, being less formal than other forms of
52
care, encourage more people to attend for preventative care and/or treatment and/or
may promote increased adherene to treatment recommendations (Moffatt &
Oldroyd, 1994; Russell & Bowles, 1992).
Recurrence of Venous Leg Ulcers
Recurrence Rates
Although recurrence rates of venous leg ulcers vary considerably in the literature,
rates are generally high, with half to two-thirds of patients expected to return with a
recurring ulcer. It has been estimated that even if the average time to recurrence
was extended by one month, the costs associated with community nursing time
spent on chronic leg ulcers would drop by 8% (Flaherty, 2005a).
The most frequently stated long term (two to five years post healing) recurrence
rates for patients without any preventive interventions are around 60 – 70% (Abbade
et al., 2005; Baker & Stacey, 1994; Barwell et al., 2004; Bonham, 2003; Christensen
& Yeager, 2001; McDaniel et al., 2002; Moffatt & Dorman, 1995). Twelve month
recurrence rates are reported as ranging from 46 to 72 percent (Christensen &
Yeager, 2001; Ghauri et al., 2000; Lees & Lambert, 1992). Even within the first three
months following healing, recurrence rates from 10 – 30% have been reported
(Kjaer et al., 2005; Monk & Sarkany, 1982), and rates of 10 – 50% by six months
(Fassiadis et al., 2002a; Iglesias et al., 2004). Vowden and Vowden (2006) and
Moffatt and Dorman (1995) noted that the highest rates of recurrence were within
the first three months after healing.
Lower recurrence rates of 17 – 34% at 12 months have been reported with the
consistent use of compression hosiery after healing (Abbade et al., 2005; Barwell et
al., 2004; Barwell et al., 2000b; Franks et al., 1995c; Iglesias et al., 2004; Moffatt &
Dorman, 1995; Vandongen & Stacey, 2000); and low rates of 11 – 17% at 12
53
months have also been reported in studies following patients with superficial venous
insufficiency who were suitable for venous surgery (Barwell et al., 2004; Barwell et
al., 2000b; Gohel et al., 2005a). Longer term recurrence rates after four years
reported for patients using compression were 51%, in comparison to 31% of patients
who underwent surgery for superficial venous reflux in addition to wearing
compression (Gohel et al., 2007).
Risk Factors for Recurrence
A number of risk factors have been identified as associated with high recurrence
rates, many of which are indicative of the severity of venous disease and similar to
the factors associated with delayed healing of venous leg ulcers. They include a
larger previous ulcer size (Moffatt & Dorman, 1995; TenBrook et al., 2004),
specifically if over 10cm2 (Franks et al., 1995c; Vowden & Vowden, 2005); number
of previous ulcerations (Nelson et al., 2006) and prolonged ulcer duration of the
previous ulcer(s) (Barwell et al., 2000a; Gohel et al., 2005b; Magnusson et al., 2006;
Nelson et al., 2006). Other medical risk factors are a history of deep vein thrombosis
(Abbade & Lastoria, 2005; Franks et al., 1995c; McDaniel et al., 2002; Moffatt &
Dorman, 1995), lipodermatosclerosis (Nelson et al., 2006) and presence of deep
vein insufficiency (Barwell et al., 2004; Gohel et al., 2005b; McDaniel et al., 2002).
Comorbidities such as rheumatoid arthritis and diabetes have been associated with
higher recurrence rates in a couple of studies (Barwell et al., 2000a; Ghauri et al.,
2000), although earlier studies have found the presence of diabetes had no
significant effect on time to recurrence (Erickson et al., 1995; Franks et al., 1995c).
A large study by Barwell et al. (2000) found no association between patient
mobility scores and either healing or recurrence, as also noted by Franks et al.
(1995). However, patient mobility and/or restricted ankle movement were
significantly related to recurrence rates in studies by Brooks et al. (2004), Vowden
54
and Vowden (2005) and Nelson et al. (2006), suggesting a need for further research
in this area. It has also been reported from a study of 600 patients that
disadvantaged social groups are more likely to have recurrent ulcers (Callam et al.,
1988).
Preventing Reurrence
There is little evidence available on effective strategies to prevent venous leg
ulcer recurrence. The prevention strategies currently recommended are based on
factors known to be associated with improved venous ulcer healing or decreased
venous insufficiency, i.e., strategies aimed at improving venous return and general
health, such as maintaining good skin condition, wearing compression garments, leg
elevation, maintaining optimal nutrition, and obtaining regular follow up and
monitoring. However many authors have noted that apart from compression, there is
little evidence to support the advice given to patients on self care preventive
strategies (Kelechi & Edlund, 2005; Nelson, 2001; Peters, 1998; Royal College of
Nursing, 2006).
Physiological factors influencing recurrence
Compression
Life long compression therapy is one strategy with evidence of effectiveness in
preventing recurrence, although data on the optimal level and type is limited.
Systematic reviews of compression therapy have found that although compression
was effective for healing venous leg ulcers, there have been no ‘dose related’
studies to identify the the amount needed to prevent reccurence [ I ] (Cullum et al.,
2001b; Nelson et al., 2000). There is some evidence that the use of compression
hosiery is more effective than no compression in preventing recurrence [II] (Franks
et al., 1995c; Harper et al., 1999), but difficulties with patient compliance in wearing
55
compression hosiery has limited generalisations from the findings of some of these
studies. Since the review in 2000 a randomized controlled trial of class two and
class three compression hosiery has been published, which found no significant
difference in recurrence rates between the two levels of compression, however,
patients in class three hosiery were less compliant with wearing their hosiery [II]
(Nelson et al., 2006).
Surgery for venous incompetence
Superficial venous surgery plus compression in patients with superficial
insufficiency has been found to significantly reduce recurrence rates, for example,
12% recurrence rate at 12 months for patients following surgery plus compression,
in comparison to 28% of patients in compression alone [ II ] (Barwell et al., 2004);
27% recurrence at 4 years following surgery in comparison to 67% for those in
compression alone [IV] (McDaniel et al., 2002); and 31% at 4 years following
surgery in comparison to 56% for those in compression alone [ II ] (Gohel et al.,
2007). A study of outcomes from combining superficial venous surgery with
perforator surgery also reported low recurrence rates of 18% at five years from
surgery [IV] (Nelzén & Fransson, 2007).
It is therefore recommended that patients with superficial venous incompetence
be referred for venous surgery. Unfortunately, only around 10 – 50% of patients
have superficial insufficiency alone (Adam et al., 2003; Arcelus & Caprini, 2002;
Barwell et al., 2004; Magnusson et al., 2001; Naik et al., 2000) and many patients
are unsuitable for surgery due to their age and comorbidities (Arcelus & Caprini,
2002). Davies et al. (2004) noted that of 759 patients with venous leg ulcers, only 75
were able to be randomised for surgery, due mainly to problems with either no
superficial insufficiency, or the presence of comorbidities restricting patients’
suitability for surgery. A systematic review of surgery techniques for deep vein
56
incompetence found insufficient evidence of effectiveness to recommend its use [ I ]
(Hardy et al., 2004a). This population therefore requires the addition of alternative
strategies for prevention of recurring ulcers.
Leg elevation and exercise
Measures of activity, exercise or time spent with legs elevated are rarely reported
in studies of recurrence (Gethin, 2002). Elevation of the affected legs above the
level of the heart and regular walking and ankle exercises are recommended to
prevent recurrence in best practice guidelines for caring for patients with venous leg
ulcers (Arrol et al., 1999; Registered Nurses' Association of Ontario (RNAO), 2004;
Royal College of Nursing, 2006; Stacey et al., 2002), although reviews in 1998
(Peters) and 2001 (Nelson) note that these strategies are supported only by expert
opinion. However, physiological studies of calf muscle pump function following
exercise in patients with venous insufficiency have found improved strength and calf
muscle pump function (Padberg et al., 2004; Yang et al., 1999b), suggesting a need
for further investigation in this area. In addition, a recent study with 50 patients found
significantly reduced recurrence in an intervention group who spent greater time with
legs elevated than the control group [III-2] (Brooks et al., 2004).
Nutrition
Poor nutrition and a high BMI have been suggested to delay healing in venous
leg ulcers (Iglesias et al., 2004; Meaume et al., 2005; Taylor et al., 2002). A small
study by Wissing, Ek and Unosson (2001) found patients with recurrent ulcers had
decreased Mini-Nutritional Assessment scores over time [IV], however in general
there has been little research investigating the association between poor nutrition
and leg ulcer recurrence and further research is indicated in this area.
57
Psychological factors influencing recurrence
Depression, stress and anxiety have been associated with delayed healing in
acute wounds (Cole-King & Harding, 2001; Doering et al., 2005; McGuire et al.,
2006) and depression has been reported in a significant number of patients with
chronic leg ulcers (Hareendran, 2005; Jones et al., 2006; Persoon et al., 2004).
However, there were no studies found investigating the relationships between
depression, stress or anxiety and recurrence rates of chronic leg ulcers.
As well as a direct effect on the immune system and normal healing processes,
depression may also have an indirect effect on recurrence by impacting on self care
activities to prevent recurrence. Close relationships between depression, self
efficacy and health promoting activities have been reported in evaluation studies of
self management programs for other chronic conditions (Brody et al., 2006;
Buszewicz et al., 2006; Jeon & Kim, 2006). Strategies to prevent recurring leg ulcers
are based on acceptance of the condition as a lifelong chronic disease requiring
permanent modifications to lifestyle. Adherence to self care activities aimed at
preventing recurrence is therefore reliant on understanding and agreement with the
proposed prevention regimen. Difficulties in both these areas have been reported in
patients with chronic leg ulcers.
Compression therapy is the major preventive strategy recommended to patients
with chronic leg ulcers (Arrol et al., 1999; Registered Nurses' Association of Ontario
(RNAO), 2004; Royal College of Nursing, 2006; Stacey et al., 2002). Unfortunately,
compliance with wearing compression garments is notoriously inconsistent (Anand
et al., 2003; Arcelus & Caprini, 2002; Field, 2004; Flanagan et al., 2001; Graham et
al., 2001), with compliance rates reported as ranging from 12% (Raju et al., 2007),
32% (Erickson et al., 1995), 35% (Seppanen & Livanainen, 2005), 47% (Samson &
58
Showalter, 1996), 52% (Jull et al., 2004a) to 61% (McDaniel et al., 2002) for wearing
compression every or nearly every day.
Investigations into reasons for non-compliance with wearing compression
garments have found some patients have practical problems with their physical
ability to apply compression garments (Flaherty, 2005b; Flanagan et al., 2001;
Franks et al., 1995c; Nelson, 2005), although Jull et al.’s (2004a) results found
difficulty in applying stockings was not associated with stocking use. However,
patients have reported compression garments are a bother, uncomfortable, painful,
hot, irritating to the skin, cause difficulties with footwear and adversely affect their
lifestyle (Anand et al., 2003; Edwards, 2003; Flaherty, 2005b; Franks et al., 1995c;
Jull et al., 2004a; Raju et al., 2007). Franks et al. (1995c) found of 166 patients,
15% could not put their stockings on at all and another 26% only with great difficulty.
Patients have expressed concern that health professionals do not understand the
difficulties associated with compression and the impact of their problems, leading to
disempowerment and disagreement with treatment regimens (Chaby et al., 2006a).
In addition, they have reported feelings of guilt and blame related to adherence with
self care activities and recurrence (Flaherty, 2005a; Flanagan et al., 2001).
Studies of patients’ understanding of their condition and treatment have generally
shown poor levels of knowledge and a need for further education (Brown, 2005b;
Edwards, 2003; Edwards et al., 2002; Flanagan et al., 2001; Heinen et al., 2006).
Poor understanding has been identified as a barrier to self care activities and
patients have reported confusion at apparently conflicting advice (eg. to exercise
regularly but also rest with legs elevated) without an understanding of the reasoning
behind the recommendations (Flanagan et al., 2001; Heinen et al., 2006). However,
improved knowledge alone may not influence compliance rates, as shown by an
evaluation which found no improvement in compliance with compression following
59
implementation of an education program on prevention of recurrence [III-2] (Brooks
et al., 2004).
Consideration of patients’ health beliefs has also been discussed in the literature,
with authors noting that some patients are not interested in healing (Brown, 2003;
Flanagan et al., 2001), or believe various folk tales that suggest they will die if their
ulcer heals (Lindsay, 2000). The need to wear compression garments for the rest of
their lives can be perceived as a daunting prospect (Gethin, 2002), and many
patients express a belief in the inevitability of recurrence and disbelief in the
effectiveness of wearing compression to prevent recurrence (Brown, 2003; Flaherty,
2005b; Flanagan et al., 2001; Harker, 2000; Raju et al., 2007). The belief that
wearing compression hosiery was worthwhile in preventing recurrence has been
found in a couple of studies to distinguish patients who are compliant with wearing
compression hosiery from those who are not (Flaherty, 2005b; Jull et al., 2004a);
while Flaherty (2005b) described a range of patient beliefs regarding compression
hosiery, from those who felt safer with stockings on as protection, to those who
believed they shouldn’t require permanent treatment and reliance on artificial
support such as hosiery would weaken their legs or worsen the condition.
Political and socio-economic factors influencing recurrence
Socio-economic factors
Research into socio-economic factors and recurrence of leg ulcers is limited. A
relationship between socioeconomic class and the presence of leg ulcers has been
found (Moffatt et al., 2006), and an early study (Callam et al., 1988) found leg ulcers
were more likely to be recurrent in patients from lower socioeconomic classes. The
costs associated with care (including preventive care) for chronic leg ulcers are
known to be high, both to society and to the patient. As the patient group is elderly,
60
costs of treatment are likely to have a significant impact on their self care practices.
However, only a couple of studies have examined the issue, with conflicting results.
Samson and Showalter (1996) found cost was a major reason for non-compliance
with wearing of compression hosiery to prevent recurrence, however Jull et al.
(2004a) found cost did not influence the decision to purchase compression
stockings.
Social support has been identified as a significant influence on health promoting
behaviours and self management of chronic disease (Heinen et al., 2006; Morgan et
al., 2004; Sousa et al., 2004)). The presence of leg ulcers has been significantly
associated with being single and poorer levels of social support (Moffatt et al.,
2006), but in general there have been few studies on the impact of social support on
prevention of recurrence. A small study by Wissing et al. (2001) noted that patients
whose leg ulcers did not recur scored significantly higher on measures of social
interaction than patients whose ulcers did not heal or recurred. However, the
measures were not taken prior to recurrence so it is difficult to determine whether
the decreased social interaction was present before recurrence or deteriorated as a
result of the current ulcer. On another angle, Nelson (2005) found that having a role
as a care provider for another member of the household was one factor encouraging
self care activities for chronic leg ulcers.
Health care system and policies
Guidelines for care of patients with chronic venous leg ulcers from the U.K.
(Royal College of Nursing, 2006), Canada (Registered Nurses' Association of
Ontario (RNAO), 2004) and New Zealand (Arrol et al., 1999) suggest prevention of
recurrence of leg ulcers requires regular follow up care, education on preventive
measures and strategies to promote self management of chronic venous
insufficiency, based on expert consensus. However, authors from a number of
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countries and health care systems have described confusion over who owns
responsibility of care and the difficulties faced by chronic leg ulcer patients in
obtaining health services which provide consistent long term preventive and chronic
disease management care (Flaherty, 2005b; Flanagan et al., 2001; Persoon et al.,
2004). The majority of leg ulcer patients are community living and access health
care through a mixture of acute, general, specialist and community health care
services, requiring complex communication and organisation to achieve continuity of
care between services. Problems with poor communication between health
professionals and poor integration of health care services have been described
frequently in the literature (Flanagan et al., 2001; Ghauri et al., 2000; Graham et al.,
2001; Harrison et al., 2005).
To overcome these difficulties and provide regular follow up and preventive care,
a number of dedicated clinics for regular leg ulcer follow up care and/or education
programs to prevent recurrence have been established and evaluated (Bentley,
2001; Erickson et al., 1995; Fassiadis et al., 2002a; Flaherty, 2005a; Ghauri et al.,
2000; Poore et al., 2002; Ruane-Morris et al., 1995). These studies have generally
reported relatively low recurrence rates, for example, 5% [IV] (Flaherty, 2005a) and
23.7% [IV] (Fassiadis et al., 2002a) at six months after healing, 16% [IV] (Bentley,
2001) to 17% at 12 months [III-2] (Ghauri et al., 2000), and 22% at 24 months [IV]
(Poore et al., 2002). The clinics provided regular monitoring and referral for
specialist treatment as appropriate and education on skin care, early signs and
symptoms to encourage early intervention, leg elevation, exercise, nutrition and
compression (Flaherty, 2005a; Poore et al., 2002). However, only one of these
studies had a control group and further research into the relative effect or
importance of each of the various elements of the follow-up programs would be
beneficial. Some of these evaluations report improved or high rates of compliance
with wearing compression hosiery [III-2 – IV] (Bentley, 2001; Ghauri et al., 2000;
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Poore et al., 2002). In contrast, Erickson et al. (1995) found only 32% of patients
were compliant with the treatment regimen within their program [IV].
A recent review of studies on interventions to promote compliance with ulcer
treatment found no conclusive evidence that any healthcare system interventions
increased compliance (Van Hecke et al., 2008). One education program combining
cognitive, behavioural and affective components was shown to have a positive effect
on leg elevation, although not on compliance with compression therapy [III-2]
(Brooks et al., 2004). Another program reported in the literature incorporated a
monthly support group to promote self-care of their condition and patient interviews
indicated a positive response, however, there were no measurements of health
outcomes (Freeman et al., 2007).
Summary of Literature on Venous Leg Ulcers
Chronic venous leg ulcers are associated with pain, restricted mobility and
decreased quality of life. The average leg ulcer takes around six months to heal and
once healed, there is a 60 – 70% chance of recurrence. There is limited evidence
available on effective measures to prevent recurrence. Most currently recommended
strategies concentrate on measures to improve the impaired venous return and
reduce venous hypertension, such as use of compression therapy, leg elevation,
lower limb exercise and maintaining a healthy weight. Of these strategies, only the
use of compression therapy has been demonstrated to be associated with lower
recurrence rates and there is limited information on the optimal type and level of
compression required. In addition, the wearing of compression garments is a
problematic long term strategy, associated with discomfort, restrictions in lifestyle,
difficulties in application and poor rates of adherence.
63
Wound healing and breakdown is known to be a complex process involving many
factors, including not only circulation, but age, coexisting disease, nutrition,
psychological influences and socioeconomic factors. Many of these areas have not
yet been explored with regard to recurring leg ulcers. Previous research on
recurrence has concentrated on demographic and/or medical risk factors for
recurrence and a small number of studies have investigated the effect of
compression and/or surgery on recurrence rates. In recognition of the problems with
compression therapy, exploratory studies of reasons for non-compliance with
compression therapy have also been undertaken and results point to the
multifactorial difficulties associated with this strategy for prevention. Further
investigation into alternative measures to reduce venous hypertension, such as
exercise and leg elevation, is necessary. Other areas for consideration when
examining recurrence include the possible effects of depression and stressors on
healthy tissue physiology; and the potential impact of psychosocial factors such as
depression, self efficacy and social support on patients’ preventive and chronic
disease self management activities. Few studies have taken a systematic
comprehensive approach to research in this area by including a combination of
these physiological, psychological and socioeconomic variables to determine direct
and indirect influences on recurrence. This study therefore plans to utilize a
conceptual framework encompassing these areas to investigate relationships
between ulcer recurrence and demographic variables, compression, physical
activity, leg elevation, nutrition, depression, general self efficacy, self-care activities,
quality of life and social support in this group after ulcer healing.
64
Conceptual Framework
Findings from this literature review indicate that a combination of factors from
physiological, psychological, social and political systems may influence the absence
or frequency of recurring leg ulcers. To explore the relative impact and interactions
of these factors on the development of recurring ulcers, a broad framework is
required which guides investigation into both direct influences on leg ulcer
recurrence (e.g. physiological factors such as exercise) and indirect influences on
recurrence (e.g. psychological, social and economic factors affecting self care
activities and chronic disease management). Published theories of wound healing
are primarily concentrated on direct biological and physiological processes involved
in acute wound healing. Many aspects of these theories are relevant to prevention of
ulcer recurrence (e.g. maintaining normal circulation) and should be included in a
framework for research into recurrence. However, the area of leg ulcer recurrence is
focused on prevention rather than wound healing, and involves self management of
chronic venous insufficiency; therefore theories of chronic disease management,
health behaviours and health promotion are also applicable.
A small number of conceptual models of wound management have been
developed, including models primarily based on physiological principles of wound
care (Schultz et al., 2003) and a couple with a broader focus for management of
clients with chronic wounds (Morison et al., 2007; Popoola, 2003b). The latter two
models (Morison et al., 2007; Popoola, 2003b) have included the physiological
aspects of wound healing within a holistic framework of physiological, psychological,
social, cultural and political influences relevant to care of a client with a chronic
wound. As these models have been developed for the assessment and
management of active wounds rather than for preventive activities, self management
and preventive health activities are not a major focus. However, many of the factors
identified as influencing chronic wound management have been identified in this
65
literature review as potentially relevant to prevention of leg ulcer recurrence after
healing. In order to modify these models to be appropriate for research into
prevention of recurrence, a combination of aspects from chronic wound
management models and chronic disease management theories is proposed to
provide a framework for this study.
Two conceptual frameworks have been identified from the literature, one specific
to chronic wound management (Popoola, 2003a), the other designed for study into
management of chronic conditions (Grey et al., 2006). Popoola developed a model
for chronic wound management using a holistic view of health, where a holistic plan
of care is defined as “an active, interactive and collaborative process between
patient and (health care) provider” (Popoola, 2003a, p. 156). The model was
designed following a review of the literature of factors influencing chronic wound
management and a subsequent study with 60 health professionals with wound care
expertise on their perceptions of the relative importance of factors from
physiological, psychological, economic, spiritual and political spheres on chronic
wound management strategies and outcomes.
Using theories from holistic, caring and systems nursing theorists (including
Leninger, 1991; Newman, 1992 & Watson, 1979) as a basis for the framework, the
model nominates five categories which impact on the client with a chronic wound
and thus influence management of chronic wounds: physical, psychosocial, spiritual,
political and economic categories. Within each of these categories, variables
specific to clients with chronic wounds are identified, such as circulation and
nutrition within the physiological category; and depression and knowledge within the
psychological category (see Figure 1). These variables were nominated and
confirmed from the results of the survey of wound care experts. The five categories
all influence the client with a chronic leg wound (represented in the centre of the
diagram in Figure 1) and recognition is made of the reciprocal
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relationships between categories with bi-directional arrows. The interactions of
categories, variables and client with a chronic wound are combined within a circle
which leads to an overall goal of caring and healing of the chronic wound as shown
in the base of the model (Popoola, 2003b). The broken lines between
categories,variables and client with a chronic wound indicate a gap in available
knowledge and the need for further research on the strength and nature of
relationships between these factors (Popoola, 2003b).
Figure 1. Popoola’s model for chronic wound management
Reprinted from Holistic Nursing Practice, Vol 17, Popoola, M., ‘Complementary
therapy in chronic wound management: A holistic caring cast study and praxis
model’, p. 155, 2003, with permission from Wolters Kluwer Health)
67
In addition, as research into influences on recurrent leg ulcers includes
investigation of chronic disease management and preventive self care activities,
concepts from Grey et al.’s (2006) self-management of chronic conditions
framework are also proposed to be included in a framework for this study. Grey et
al. (2006) developed a conceptual framework to guide research and development of
theory into self and family management of chronic conditions. The framework was
developed from a review of theories related to self management of chronic disease,
including aspects from social cognitive theory and the concepts of self care, health
beliefs and self efficacy (Grey et al., 2006). Social cognitive theory focuses on the
complex, dynamic relationships between the individual, health behaviours and their
environment, where all elements interact and influence each other within reciprocal
relationships (Nutbeam & Harris, 2004). The individual’s expectations, beliefs and
level of self efficacy are considered important determinants of health behaviours, but
it is recognised that behaviours are also influenced by environmental factors, such
as the social and political context. Social cognitive theory has been widely used and
tested successfully with health promotion interventions, including interventions for
management of chronic disease (Motl, 2006; Oliver, 2005) and health promoting
behaviours in older adults (Richeson, 2006; Shields et al., 2006).
Grey et al.’s framework for management of chronic conditions proposes four
categories of variables which act as risk or protective factors influencing self
management practices and their outcomes, whilst the self management practices
themselves also influence the risk and protective factors and outcomes. The four
categories of risk and protective factors are:
• the effects of health status or chronic condition specific factors (e.g.
severity of disease and treatment regimen);
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• individual and psychosocial factors (e.g. age, depression, knowledge);
• family factors (e.g. socio-economic status, supportive relationships); and
• environmental factors (e.g. community, health care system).
(Grey et al., 2006), see Figure 2.
Figure 2. Grey et al.’s Framework for self and family management of chronic
conditions. (Reprinted from Nursing Outlook, Vol 54, Grey et al., ‘A framework
for the study of self-and family management of chronic conditions’, p. 282, 2006,
with permission from Elsevier)
It is proposed to include aspects from both the above models to provide a
framework to guide this study into factors influencing leg ulcer recurrence. Many
category variables from Popoola’s model overlap with the risk and protective factors
69
from Grey et al.’s model. For the purpose of this study, some of the factors which
are not relevant to research into prevention of recurrent leg ulcers will be omitted
and the relevant overlapping factors combined in a new model for prevention of leg
ulcer recurrence (see Figure 3). The relevant factors to leg ulcer recurrence
influencing outcomes from Popoola’s and Grey et al.’s models are listed below in
Table 1, alongside the related factors which are proposed for inclusion in the model
for prevention of leg ulcer recurrence. As in Grey et al.’s framework, self
management of chronic disease is included as both an outcome and as an
influencing factor on outcomes of self care activities (recurrence) in this framework
for prevention of recurring leg ulcers. However, for the purpose of this study, the
main outcome of interest will be limited to recurrence of leg ulcers.
The framework (Figure 3) displays hypothesised relationships between:
• physiological, psychological and self management factors directly
influencing recurrence of leg ulcers (e.g. compression prevents
recurrence, depression affects tissue functioning/breakdown and self care
activities may prevent recurrence)
• physiological, psychological and socioeconomic/political factors
influencing self care activities and chronic disease management
(e.g. comorbidities affect ability to apply compression garments, family
support affects motivation to continue self care activities, health care
system policies affect access and affordability of compression garments)
• physiological, psychological and socioeconomic/political factors
themselves influencing each other (e.g. severity of venous disease or
comorbidities may affect self efficacy, knowledge and depression may
affect activity levels, socioeconomic status may affect nutrition and access
to health care)
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Table 1. Variables influencing outcomes from Popoola’s Chronic Wound Management Model, Grey et al.’s Management of Chronic Conditions
Framework and the proposed framework for prevention of recurrence of venous leg ulcers
Popoola’s Chronic Wound Management Model
Grey et al.’s Management of Chronic Conditions Framework
Framework for prevention of recurrent leg ulcers
Category Variable Risk/Protective Factor groups
Variable Category Variable
Physiological environment
Circulation Health status & chronic condition specific factors
Severity of condition Physiological factors
Venous disease and ulcer variables
Health status Physical activity
Nutrition Nutrition
Chronic illness Co morbidities / age
Psychosocial & spiritual environment
Depression Individual factors & psychosocial factors
Depression Psychological factors
Depression
Self drive / hope Self efficacy Self efficacy
Knowledge Knowledge
Support system Support Social support
Compliance Self management Individual self management
Self care activities
Compression
Leg elevation
Economical environment
Transportation
Accessibility
Costs of products
Family factors Socio-economic status
Resources
Socio-economic and deomgraphic factors
Socio-economic status
Health care system organisation
Political environment Reimbursement Environmental context Community
Policies Health care system
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Figure 3. Conceptual framework for recurrence of venous leg ulcers A. Direct influence on recurrence B. Indirect influence on recurrence via influence on self care activities
PHYSIOLOGICAL FACTORS: Comorbidities
Venous history
Physical activity
Nutrition
SOCIODEMOGRAPHIC FACTORS: Gender / age SES / income Health care system
PSYCHOSOCIAL FACTORS: Social support Self-efficacy Depression Knowledge
Self care activities:
Compression
Leg elevation
Recurrence
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Conclusion
This chapter provided a review of the literature relating to recurrence of venous
leg ulcers and a conceptual framework to guide the research. Current knowledge on
prevention of recurrence of venous leg ulcers is limited to awareness of the high
rates of recurrence, the significant impact of the disease on health and quality of life,
and some evidence on the effectivenesss of compression therapy and surgery (for
patients with superficial venous insufficiency) in preventing recurrence. In
recognition of the problems with compression therapy, exploratory studies of
reasons for non-compliance with compression therapy have also been undertaken
and results point to the multifactorial difficulties associated with this strategy for
prevention. There is little or no evidence to support many of the commonly
recommended strategies to prevent recurrence, such as reducing weight, eating a
nutritious diet, leg elevation and lower limb exercises.
Wound healing and breakdown is known to be a complex process involving many
factors, including not only pathophysiology, but psychological influences and
socioeconomic factors. Many of these areas have not yet been explored with regard
to recurring leg ulcers. Few studies have taken a systematic comprehensive
approach to research in this area by including a combination of these physiological,
psychological and socioeconomic variables to determine direct and indirect
influences on recurrence. This study therefore plans to utilise a conceptual
framework encompassing these areas to investigate relationships between ulcer
recurrence and demographic variables, compression, physical activity, leg elevation,
nutrition, depression, general self efficacy, self-care activities, quality of life and
social support in this group after ulcer healing.
73
A conceptual framework has been developed to guide research with participants
suffering from chronic venous insufficiency and recurring venous leg ulcers. This
framework is based on previously published models specific to chronic wound
management (Popoola, 2003a) and management of chronic conditions (Grey et al.,
2006). The proposed framework (Fig. 3) includes aspects from both models as
research into influences on recurrent leg ulcers includes investigation of factors
specific to chronic wounds and those relating to chronic disease management and
preventive self care activities.
Results from the retrospective study (Study 1) are presented in Chapters 3 and 4.
Chapter 3 describes the methods, results and discussion answering the research
questions on relationships between recurrence and demographic, health, physical
activity, psychosocial and self care activity variables (research questions 1, 2, 3, 4
and 6).
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75
CHAPTER 3
A retrospective investigation of the impact of physiological variables,
psychosocial factors and preventive self-care strategies on recurrence
of venous leg ulcers.
Introduction
The review of the literature on leg ulcer recurrence found there was limited
information available on strategies to prevent recurrence and how physical and
psychosocial factors may influence recurrence. The focus of the overall research
was therefore explorative in nature. Two studies were undertaken based on
quantitative explorative designs: the first was a retrospective medical record review
and cross-sectional survey; the second was a prospective longitudinal study with
patients who were recruited upon healing of their venous leg ulcer and followed up
regularly for 12 months after healing.
This chapter describes the methods, results and discussion of findings from the
retrospective study related to determining relationships between strategies to
prevent recurrence, physiological variables, psychosocial factors and recurrence of
venous leg ulcers. The aims, results and discussion of findings are primarily
reported in the published article ‘Factors associated with recurrence of venous leg
ulcers: A survey and retrospective chart review’, International Journal of Nursing
Studies, Vol. 46(8): 1071–1078, which is reproduced in this chapter. However, as
the methods section in the journal article was necessarily succinct to meet the
journal’s word limit, the full details of methods are provided in the following section.
76
Methods
Design
A survey and retrospective medical record review was undertaken of patients
previously diagnosed with a venous leg ulcer which had healed between 12 to 36
months prior to the survey, to determine relationships between ulcer recurrence and
demographic variables, comorbidities and medical variables, general health and
physical activity levels, psychosocial variables and self care activities to prevent
recurrence.
Research Questions
1. Do recurrence rates vary according to demographic, health or venous history
variables?
2. What was the relationship between recurrence and level of physical activity?
3. What was the relationship between recurrence and the psychosocial
variables of depression, self-efficacy and social support?
4. What was the relationship between recurrence and self care activities relating
to chronic venous insufficiency?
5. Does adherence to self-care activities (specifically wearing compression
hosiery) vary according to demographic, health or psychosocial variables?
6. What are the independent relationships between recurrence and
demographic, health, physical activity, psychosocial and self-care activity
variables after adjusting for all variables and potential confounders in a
multivariable regression model?
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Sample
All patients who had previously received care during 2004 – 2007 at the leg ulcer
clinics at Princess Alexandra Hospital, Royal Brisbane & Women’s Hospital or
Spiritus community nursing service and who met the inclusion and exclusion criteria
listed below were sent an information and consent package, the survey, and a letter
of invitation to participate via post.
Sample size calculations prior to commencement of the study found a sample of
150 clients would be required, based on the following parameters: 90% power; 95%
significance level; able to detect significant clinical differences between groups
based on results from previous work in this area (e.g. a 20% difference in
proportions) and allowing for a 25% non-response rate.
Inclusion and exclusion criteria included the following:
Inclusion Criteria
• Clients with a previous leg ulcer of venous aetiology (diagnosed as
venous by the clinician in charge of the leg ulcer clinic)
• Ankle Brachial Pressure Index over 0.8 and less than 1.3
• The previous ulcer was completely healed (full epithelialisation maintained
for at least two weeks) between 12 to 36 months prior to the survey
Exclusion Criteria
• Clients unable to mobilise at all i.e. completely bed or wheelchair bound
• Ankle Brachial Pressure Index ≤0.8 or ≥1.3
• Clients who were unable to understand English
• Clients with a diagnosed cognitive impairment
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Data collection and measures
Information on demographic and medical history, ulcer variables (size and
duration), ulcer treatments, preventive treatments prescribed following healing
(including level, type and length of time of compression), recurrence and length of
time to recurrence was obtained from medical records. The postal survey gathered
data relating to recurrence which may have been missing from medical records (e.g.
recurrences and time to recurrence may have been recorded at other health care
providers, or the patient may not have attended any health care provider), in
addition to updated information since discharge from the clinics. The survey also
included instruments to measure physical activity levels, nutrition, health-related
quality of life, depression, self-efficacy, social support and self care activities to
prevent recurrence.
Data were collected on:
• Socio-demographic data (age, gender, socio-economic status using the
Australian SEIFA codes, income source, employment, living
arrangements)
• medical history (comorbidities, medications)
• venous history and ulcer characteristics (including history of past deep
vein thrombosis, previous venous surgery, varicose veins, venous
eczema, ankle and leg oedema, ulcer size, ulcer duration, ulcer
treatments, date of healing)
• level of mobility and exercise (including the Yale Physical Activity Survey
• nutrition (weight, height, Short-Form Mini-Nutritional Assessment)
• health related quality of life (SF-12)
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• depression (Geriatric Depression Scale)
• social support (Medical Outcomes Study Social Support Scale)
• self efficacy (General Self-Efficacy Scale)
• self care activities related to prevention of ulcer recurrence (level, type
and length of time in compression, frequency and duration of leg
elevation, frequency and duration of ankle or calf muscle exercises, skin
care activities)
Instruments
A copy of the instruments and chart audit tool is provided in Appendix A.
The Yale Physical Activity Survey (YPAS) (Dipietro et al., 1993b) consists of 36
items designed to assess physical activity levels in older adults. The items cover the
amount of time spent during a typical week undertaking exercise, household and
recreational activities. There are two sections, with the first section measuring the
amount of time spent on normal activities, housework and exercise over a typical
week and the second section asking about frequency and duration of exercise,
walking, standing and sitting activities. Moderate to high validity and reliability have
been established in a number of studies (Harada et al., 2001; Kolbe-Alexander et
al., 2006; Washburn, 2000). The YPAS has been validated with measures of weekly
energy expenditure (r = 0.47, p = 0.01), hours spend sitting daily (r = 0.53, p = 0.01)
and oxygen consumption (VO2 max, r = 0.58, p = 0.004) in early development
studies (Dipietro et al., 1993a); while later studies have found associations with
YPAS and the SF-36 and performance measures (r ranging from 0.44 – 0.68,
Harada et al. 2001); criterion validity with comparisons to accelerometer data
reported as ranging from 0.31 – 0.54 (Kolbe-Alexander et al., 2006); and
comparisons of YPAS energy expenditure to energy expenditure calculated from
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dietary intake (r = 0.94, p = 0.002, Campbell et al. 1997). Tests of reliability have
reported correlations of 0.42 – 0.65 (Dipietro et al., 1993a) and 0.44 – 0.8 for men
and 0.59 – 0.99 for women (Kolbe-Alexander et al., 2006).
The Short-Form Mini-Nutritional Assessment (MNA-SF) (Rubenstein et al., 2001)
is a 6 item tool to screen for nutritional status in the geriatric population. It was
developed from the longer well-validated MNA tool to provide a practical, rapid tool
to identify those at risk for malnutrition or malnourishment (Murphy, 2000). Reliability
and validity of the MNA has been extensively tested and significant associations
with Body Mass Index, serum albumin, total cholesterol, mid-arm circumference and
morbidity have been reported (Bauer, 2005; Gazzotti, 2000; Kuzuya, 2005;
Söderhamn, 2002). The Short-Form MNA has been tested with a predominantly
community dwelling older population and validity and correlation measures with
serum albumin and the MNA have been reported (r = 0.945), along with sensitivity of
97%, specificity 100% and diagnostic accuracy of 98.7% for predicting under
nutrition (Rubenstein et al., 2001). Kuzuya also compared the Short-Form with the
full MNA and reported the Short-Form’s sensitivity and specificity for predicting
under nutrition as 0.859 and 0.840 respectively (Kuzuya, 2005).
The Short Form-12 Health Survey Questionnaire (SF-12) (Ware et al., 1996):
The SF-12 is a 12 item version of the SF-36, developed to measure health related
quality of life. The tool covers measures of health, physical functioning, physical role
limitation, mental role limitation, social functioning, mental health and pain (Bowling,
1997). This shorter version has been reported to reproduce 90% of the variability of
the SF-36 and test-retest reliability has been 0.86 - 0.89 (Ware et al., 1996). The
SF-36 and SF-12 have both been used in populations of leg ulcer patients and been
found to be useful to detect changes in condition in this group, including changes in
pain, mental health, physical role, emotional role and vitality (Franks et al., 2003;
Iglesias et al., 2005; Walters et al., 1999).
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Geriatric Depression Scale (Short Form) (Brink & Yesavage, 1982): This
screening scale was designed to be easily completed by older people in an
outpatient setting. The self-rating item scale uses a yes/no answer format and an
abbreviated 15-item scale avoids problems of fatigue. Studies in varying settings
have shown good reliability and high sensitivity (84%) and specificity (95%) among
cognitively intact elderly people (Brink & Yesavage, 1982; McDowell & Newell,
1996). Internal consistency is reported at α = 0.88 - 0.94, test-retest reliability 0.05 –
0.98 and inter-rater reliability of 0.85 (McDowell & Newell, 1996).
Medical Outcomes Study Social Support Survey (Sherbourne, 1992): This
instrument was designed for chronically ill patients and contains 19 items measuring
the availability of four dimensions of social support: 1) tangible support (material aid
or behavioural assistance); 2) affectionate support; 3) positive social interaction; and
4) emotional /informational support (empathetic understanding, advice guidance &
feedback). Good evidence exists for its reliability and validity (McDowell & Newell,
1996). Internal consistency is reported as being high (α = 0.97) with strong
correlations (0.72 – 0.90) for item-scale correlations (Sherbourne, 1992).
General Self Efficacy Scale (GSE): The revised GSE scale consists of 10 items
to determine confidence in ability to cope with challenging situations. Good
reliability, stability, validity has been reported in a number of studies (Luszczynska et
al., 2005a; Luszczynska et al., 2005b). In a study of 5,796 participants over five
countries, GSE was positively associated with optimism, self-regulation and self-
esteem, and negatively associated with depression and anxiety across cultures and
samples (Luszczynska et al., 2005a) Leganger et al. (2000) reported satisfactory
factor structure, internal consistency (ά = 0.82, Guttman’s Coefficient 0.72),
construct validity and test-retest reliability (r = 0.82) for the GSE.
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Self Care Activity Questionnaire: A short questionnaire was developed on self
care activities related to prevention of venous leg ulcers. The questions were
developed following a review of the literature and consultation with clinical experts in
the field and clients who have experienced leg ulcers. The questions cover the
areas of compression therapy, physical measures to improve venous return, skin
care, the client’s knowledge and understanding of the condition and open questions
for comments and for nomination of any other preventive measures undertaken. The
questionnaire was pilot tested with clients and clinicians in the area and minor
modifications made in layout and wording.
The majority of these instruments are in the public domain, with the exception of
the SF-12, for which a license agreement for use of the tool was obtained.
Procedure
Ethical approval for the study was obtained from the QUT Human Research
Ethics Committee, Royal Brisbane & Women’s Hospital Human Research Ethics
Committee, Princess Alexandra Hospital Human Research Ethics Committee and
Spiritus Human Research Ethics Committee.
This was a follow-up study of patients who had agreed to participate in previous
studies which aimed to improve healing of their venous leg ulcers. All patients
admitted for care of a leg ulcer at either the Princess Alexandra Hospital leg ulcer
clinic, the Royal Brisbane and Women’s Hospital leg ulcer clinic or one of the
Spiritus Care Services community leg ulcer clinics, and diagnosed with a venous leg
ulcer by the attending clinician (and with an Ankle Brachial Pressure Index of > 0.8
and < 1.3) were invited to participate in the previous studies.
Patients identified as treated for venous leg ulcers in the previous studies, fitting
the inclusion and exclusion criteria, and who healed between 12 to 36 months prior
83
to the survey were contacted by mail with a letter of introduction and invitation to
participate, the survey and an Information Sheet and Consent Form to ask
permission to participate in the study, including permission to access their medical
records from the leg ulcer clinics and to fill in a single questionnaire. Participants
were offered the opportunity to answer the survey via telephone or in person if
preferred, or if disabilities made it difficult to fill in or return a postal survey.
The medical records of consenting patients with venous leg ulcers whose ulcer
had healed between 12 to 36 months prior to the survey were accessed. Information
was obtained using the Chart Audit Tool from records at the leg ulcer clinics held by
Spiritus (Community Nursing Service), the Royal Brisbane & Women’s Hospital and
the Princess Alexandra Hospital.
Data management
Data were entered into a SPSS database and the original surveys were stored in
a locked filing cabinet. A random sample of cases was selected to verify accuracy
of data entry.
Data cleaning and consistency checking
Frequency distributions and histograms of all variables were run in SPSS to
check for invalid, missing and inconsistent values. Continuous variable values (age,
BMI, ulcer area, ulcer duration, days/week in compression, minutes/day undertaking
leg elevation, minutes/day undertaking ankle exercises, Geriatric Depression Scale
totals, General Self Efficacy scale totals, MOS Social Support Scale totals, YPAS
totals) were checked they were within range.
The pattern of missing data was checked by testing differences between cases
with missing data and cases with no missing data and no significant differences
were found. Missing values were detected in BMI scores, and some items of the
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Geriatric Depression Scale (GDS) and MOS Social Support Scale. Two cases had
more than 5% of cases missing in both the GDS and MOS social support scale and
were removed from analysis. Missing values in the other cases were replaced with
the mean or median values.
Outliers were checked against the raw data for accuracy. There was wide
variation in ulcer areas, with a few very large ulcers, thus ulcer area was log
transformed to reduce skewness and kurtosis and obtain a more normal distribution.
Outliers in other variables were checked for accuracy and retained with their values
altered to the mean or median to reduce the deviance and thus any impact on
causing errors (Tabachnick & Fidell, 2007).
Data analysis
Data were analysed with SPSSv15 (SPSS Inc., Chicago Il). Scale total scores
were calculated from the scale items for the MNA-SF, SF-12v2, Geriatric
Depression Scale, MOS Social Support Survey, General Self-Efficacy scale and the
three YPAS subscales (Total Time Index, Energy Expenditure Index, Total Activity
Index). A variable to indicate those who scored ‘at-risk’ of nutritional deficiency
(scores of 11 or less) was calculated from the MNA-SF scores (Rubenstein et al.,
2001). Body Mass Index (BMI) was calculated from weight and height measures.
Some variables were grouped for analysis, for example, BMI scores were
grouped to those >25, those from 21 – 25, and those ≤20, as it was more clinically
appropriate to group the scores as normal, overweight or underweight to aid
understanding and applicability of results. In addition, the Class 2 and Class 3
compression hosiery groups were combined as the small number of participants
wearing Class 3 hosiery (n=8) did not allow comparisons between Class 2 and
Class3 compression hosiery. Therefore comparisons were made between
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participants not wearing any compression hosiery, participants wearing Class 1
hosiery and those wearing Class 2 or Class 3 hosiery.
Frequency histograms, normal probability plots and detrended expected normal
probability plots were run in SPSS on all continuous variables to check for normality
of distribution and homoscedasticity and to guide descriptive and bivariate analyses.
As logistic regression has no assumptions on distribution, linearity of relationships or
equal variance, variables were generally not transformed if they were not normally
distributed. An exception was ulcer area, which had an extreme range of values and
a number of outliers, and was subsequently log transformed for the initial
multivariable analysis.
Descriptive analyses were undertaken for all variables. Bivariate relationships
were tested with Chi-squared tests, independent t-tests or Mann-Whitney U tests to
examine relationships between recurrence and demographic, medical, venous,
compression, physical activity, psychosocial and self-care activity variables. As this
study had a binary outcome (recurrence yes/no) and a mixture of continuous and
categorical predictor variables, a multivariable logistic regression model was used to
analyse the variables’ independent influence on recurrence and determine
relationships between ulcer recurrence and predictor variables. The data were
checked for fit with the assumptions of logistic regression. There was adequacy of
expected frequencies and there was independence in responses of different cases.
Multicollinearity checks were undertaken using a correlation matrix and examining
Pearson or Spearman coefficients. As the YPAS summary indices and mobility
variable were significantly correlated and there was a risk of collinearity, only the
YPAS Total Activity Index subscale was entered in the model. Linearity in the logit
was tested with the Box-Tidwell approach (Tabachnick & Fidell, 2007) and no major
violations were found. Residuals from the model were checked for outliers and
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outliers with standardised residuals higher than 3 (two cases) were removed from
the analysis.
All variables significantly associated with recurrence (p<0.05 level) or previously
identified in the literature as influencing recurrence were simultaneously entered into
a multivariable logistic regression model to determine their independent influences
on recurrence. Goodness of fit tests were used to eliminate unnecessary variables
and determine the final parsimonious regression model that retained strong
prediction, as recommended by Tabachnick and Fidell (2007). Significance tests,
parameters and odds ratios were calculated for the predictor variables to determine
the degree of influence each independent variable had on recurrence outcomes.
Results and Discussion
The first article published from the retrospective study – ‘Factors associated with
recurrence of venous leg ulcers: A survey and retrospective chart review’,
International Journal of Nursing Studies, Vol. 46(8): 1071–1078, reports results
answering the research questions related to recurrence outcomes (Chapter 1,
questions 1, 2, 3, 4 and 6). A copy of the published article is provided in the
following section. Overall the regression model was significant - goodness of fit of
the model: χ2 = 57.7, p <0.001; and the R2 equivalent Nagelkerke R2 = 0.62.
Classification rates for not recurring were 69%, and 92% for recurrence. This article
discusses the investigation of relationships with recurrence shown in the conceptual
model outlined in Chapter 2 (Figure 3).
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Conclusion
This study aimed to determine relationships between the risk of leg ulcer
recurrence and demographic, health, physical activity, depression, self-efficacy,
social support and self care activity variables; and to determine the independent
relationships between recurrence and these predictive factors after adjusting for all
variables and potential confounders in a multivariable regression model.
Overall the model was significant (p <0.001), explained 62% of the variance and
correctly predicted 69% of those who did not recur and 92% of recurrences. With
regards to demographic and health variables, although a number of significant
bivariate relationships were found, only the comorbidity of cardiac disease remained
significantly associated with recurrence in the multivariable model, and the presence
of a large confidence interval limits the strength of this relationship. In contrast,
strong relationships remained between self efficacy, physical activity and the
preventive activities of leg elevation and wearing compression hosiery.
In addition to exploring the proposed relationships with recurrence outcomes
from the conceptual model, data from this study were analysed to determine the
proposed relationships with self care activities in the conceptual model -
physiological, psychological and socioeconomic factors influencing self care
activities for chronic venous insufficiency. The self care activity chosen for
investigation was wearing compression hosiery, as this is the most commonly
recommended preventive activity and the only preventive strategy at the current
time with evidence to support its effectiveness. The methods, results and
discussion from this analysis are described in Chapter 4.
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CHAPTER 4
The impact of psychosocial factors on adherence to compression
therapy to prevent recurrence of venous leg ulcers.
Introduction
An essential aspect of effective chronic disease management is adherence to
self care activities to prevent complications, such as wearing compression hosiery in
order to prevent leg ulcers resulting from chronic venous insufficiency. While
physiological variables, psychosocial factors and preventive self-care activities may
directly influence the likelihood of recurrence of leg ulcers, a number of studies have
found that various psychosocial factors have an impact on self management of
chronic disease (Brody et al., 2006; Jeon & Kim, 2006; Sousa et al., 2004) and thus
may indirectly influence outcomes such as recurring leg ulcers.
To explore these possible influences, the second part of study one examined the
relationships between psychosocial factors and self-care activities to prevent
recurrence was undertaken from data collected in the retrospective study. This
chapter describes the methods, results and discussion of findings from an analysis
of data to determine relationships between psychosocial factors and adherence to
wearing compression hosiery.
The aims, results and discussion of findings are primarily reported in the article
‘The impact of psychosocial factors on adherence to compression therapy to prevent
recurrence of venous leg ulcers’, published in the Journal of Clinical Nursing
(Finlayson K, Edwards H, Courtney M. 2010. Journal of Clinical Nursing, 19: 1289–
1297) and reproduced in this chapter. However, as noted in Chapter 3, the methods
section in the journal article was relatively brief to meet the journal’s word limit,
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therefore details of methods not elsewhere reported are provided in the following
section.
Methods
Research Questions
Research Question No. 5 (Chapter 1, p. 17) asked:
5. Did adherence to self-care activities vary according to demographic, health
or psychosocial variables?
This question was expanded into the following components to be explored in this
study:
i. What knowledge do participants’ have of their chronic condition and which
self-care activities were undertaken by this sample to prevent recurrence?
ii. Does adherence to wearing compression hosiery vary according to
demographic and/or health variables?
iii. What are the relationships between adherence to wearing compression
hosiery and the psychosocial variables of depression, self-efficacy, social
support and health-related quality of life?
iv. What are the independent relationships between adherence to wearing
compression hosiery and demographic, health and psychosocial variables
after adjusting for all variables and potential confounders in a
multivariable regression model?
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Design
This study was undertaken with data collected from the cross-sectional survey
and retrospective medical record review described in Chapter 3. Wearing
compression hosiery was chosen as the self care activity to examine as wearing
compression is one of the few strategies with some evidence to support its
effectiveness (Nelson et al., 2000) and is the gold standard treatment for prevention
of venous leg ulcers as recommended in best practice guidelines for chronic venous
insufficiency (Registered Nurses Association of Ontario, 2004; Robson et al., 2008;
Royal College of Nursing, 2006).
Sample
Details of the sample were described in Chapter 3. The sample size obtained for
the retrospective study (n = 122) was adequate for a multiple regression with a
required sample size of 112 cases as calculated for α = 0.05 and β = 0.20
(Tabachnick & Fidell, 2007). Although 90% power would have been preferable, the
time available for recruiting and difficulty retaining members of this population for
long term follow-up studies limited the numbers available for analysis.
Data Collection and Measures
Data collection details are described in the published article. The self-report
questionnaire is provided in Appendix A and the instruments used have been
described in detail in Chapter 3.
Procedure and data management
The study procedure and data management, checking and data cleaning
procedures were described in Chapter 3.
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Data analysis
Quantitative data were analysed with SPSSv15 (SPSS Inc., Chicago Il). Scale
total scores were calculated from the scale items for the SF-12v2, Geriatric
Depression Scale, MOS Social Support Survey and General Self-Efficacy scale.
Frequency histograms, normal probability plots and detrended expected normal
probability plots were run in SPSS on all continuous variables to check for normality
of distribution and homoscedasticity. Outliers and skewed data were transformed or
adjusted as described in Chapter 3. In addition, as the output variable (days/week
wearing compression hosiery) was negatively skewed, a logarithmic transformation
of this variable was undertaken. Multicollinearity checks were undertaken using a
correlation matrix and examining Pearson or Spearman coefficients. A scatter plot of
standardised residuals against standardised predicted values was generated to re-
check for normality, homoscedasticity and linearity assumptions.
Descriptive analyses were undertaken for all variables. Bivariate relationships
were tested with Pearson or Spearman correlations, independent t-tests or Mann-
Whitney U tests to examine relationships between the time spent wearing
compression hosiery and the independent variables. A linear multiple regression
model was used to analyse the relationships between the number of days per week
wearing compression hosiery (as the dependent variable) and demographic and
psychosocial variables as the independent variables.
A thematic analysis was undertaken with the qualitative data. Key themes were
identified from responses to open-ended questions regarding participants’
understanding of their condition and treatments and grouped for descriptive
analysis.
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Results and Discussion
An article has been published from this study – ‘The impact of psychosocial
factors on adherence to compression therapy to prevent recurrence of venous leg
ulcers’, Journal of Clinical Nursing, 19: 1289 – 1297. A copy of the published version
is provided in the following section. Whereas the main study (and results reported in
the first article in Chapter 3) investigated the direct relationships between
physiological, psychological and self care activities influencing recurrence of venous
leg ulcers, the results in this article report findings from analysis of the proposed
relationships between demographic, health and psychosocial factors influencing self
care activities for chronic venous insufficiency.
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Conclusion
The data analysed in this chapter from study one aimed to identify relationships
between adherence to the self-care activity of wearing compression hosiery and
demographic and psychosocial variables. The findings from the study contribute to
knowledge of the proposed relationships in the conceptual model between
adherence to self care activities and demographic, health and psychosocial
variables, confirming that knowledge, depression and self efficacy had a significant
relationship with adherence to wearing compression hosiery in this sample of clients
with chronic venous insufficiency. In contrast, demographic and health variables had
little influence after adjusting for the psychosocial variables.
The results described in Chapter 3 and Chapter 4 from the first study, a cross-
sectional survey and retrospective review, provide valuable information on factors
influencing recurrence in patients with chronic venous insufficiency. These results
informed the second study, a prospective study of patients who were followed up
regularly for 12 months from the time of healing of a venous leg ulcer. The methods,
results and discussion from the prospective study are described in Chapter 5.
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CHAPTER 5
Relationships between preventive activities, psychosocial factors and
recurrence of venous leg ulcers: A prospective study.
Introduction
The review of research evidence on leg ulcer recurrence found there was limited
information available on how self-care activities, health and psychosocial factors
influence recurrence. Two studies were therefore undertaken based on quantitative
explorative designs. Findings from the first retrospective study are described in
Chapters 3 and 4. The second study undertaken was a prospective longitudinal
study with patients who were recruited upon healing of their venous leg ulcer and
followed up regularly for the first 12 months after healing. Investigating relevant
factors (as suggested from findings of the first study) in a prospective design has the
advantage of providing the opportunity to obtain baseline measures of health,
psychosocial factors and self-care activities while the patients were healed and prior
to any recurrence. In addition, as data were collected every three months for the 12
months following healing, there was less likelihood of error in relying on participants’
memory with regard to the date of recurrence, length of time remaining healed and
the number of recurrences.
This chapter describes the methods, results and discussion of findings from the
prospective study which aimed to identify relationships between self care activities
to prevent recurrence, physiological variables, psychosocial factors and length of
time to recurrence of venous leg ulcers. The aims, results and discussion of findings
are primarily reported in the article ‘Relationships between preventive activities,
psychosocial factors and recurrence of venous leg ulcers: A prospective study’,
Journal of Advanced Nursing, (accepted subject to minor revisions 5/02/2010,
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Manuscript ID JAN-2009-0895) and reproduced in this chapter. As noted in the
previous chapters, a full description of methods is not covered in the methods
section of the journal article due to space requirements, therefore details of methods
not elsewhere reported are provided in the following section.
Methods
Design
A prospective longitudinal study was undertaken of patients diagnosed with a
venous leg ulcer who were recruited when their leg ulcer healed, to determine
relationships between time to ulcer recurrence from healing and demographic and
health variables, physical activity levels, psychosocial variables and self care
activities to prevent recurrence. Data were collected at baseline (upon healing of the
ulcer), then follow-up data were collected every three months for 12 months
following the date of healing.
Research Questions
1. Did the time to recurrence vary according to demographic, health or
venous history variables?
2. What is the relationship between time to recurrence and level of physical
activity?
3. What is the relationship between time to recurrence and depression, self-
efficacy and social support?
4. What is the relationship between time to recurrence and self care
activities (specifically compression therapy and leg elevation) relating to
chronic venous insufficiency?
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5. What are the independent relationships between time to recurrence and
demographic, health, physical activity, psychosocial and self-care activity
variables after adjusting for all variables and potential confounders in a
multivariable regression model?
Sample
All patients who had received care during 2006 – 2009 at the leg ulcer clinics at
Princess Alexandra Hospital, Royal Brisbane & Women’s Hospital or Spiritus
community nursing service and who met the inclusion and exclusion criteria listed
below were invited to participate. This was a follow-up study of patients who had
participated in research studies to evaluate the effect of different types of
compression on healing rates of venous leg ulcers. Upon healing of their leg ulcer,
patients were sent an information and consent package via post and invited to
participate in the follow-up study.
As recommended by Collet (2003), a sample size calculation was undertaken
which found a sample of 100 participants would be required, using the following
parameters: an estimated probability of recurrence of 0.5 at 12 months, 80% power;
95% significance level; able to detect significant clinical differences between groups
based on results from previous work in this area (e.g. a 0.2 difference in proportions)
and allowing for a 20% early drop-out rate.
Inclusion and Exclusion Criteria are reported in the following article.
Data collection and measures
Details on data collection and measures are provided in the following article. A
copy of the instruments, patient survey and chart audit tool is provided in Appendix
A. This study utilised the same measures and instruments as those in the
retrospective study, including the Yale Physical Activity Survey (YPAS) (Dipietro et
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al., 1993b); the Short-Form Mini-Nutritional Assessment (MNA-SF) (Rubenstein et
al., 2001): the Short Form-12 Health Survey Questionnaire (SF-12) (Ware et al.,
1996); Geriatric Depression Scale (Short Form) (Brink & Yesavage, 1982); Medical
Outcomes Study Social Support Survey (Sherbourne, 1992); General Self Efficacy
Scale (GSE); and Self Care Activity Questionnaire. A detailed description of these
instruments is provided in Chapter 3.
Procedure
Ethical approval for the study was obtained from the QUT Human Research
Ethics Committee, Royal Brisbane & Women’s Hospital Human Research Ethics
Committee, Princess Alexandra Hospital Human Research Ethics Committee and
Spiritus Human Research Ethics Committee.
All patients attending the identified leg ulcer clinics, diagnosed with a venous leg
ulcer and fitting the inclusion and exclusion criteria were eligible to participate in the
study. Upon healing of their leg ulcer, all eligible patients were sent an information
and consent package via post and invited to participate in the follow-up study.
Participants were offered the opportunity to answer the survey via telephone or in
person if preferred, or if disabilities made it difficult to fill in or return a postal survey.
Two participants (2.5%) chose to answer the questionnaire via the telephone and
one (1.2%) via email rather than filling out the form and posting back, because of the
convenience (n = 2) or vision disabilities (n = 1). Follow-up surveys were undertaken
at 3 months, 6 months, 9 and 12 months from the time of healing.
Data management and cleaning
Data management and cleaning procedures were conducted primarily as
described in Chapter 3. Missing values were detected in one BMI score, and some
items of the Yale Physical Activity Survey, Geriatric Depression Scale (GDS), and
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MOS Social Support Scale. Overall, there were less than 5% of data points missing
and missing values were replaced with the mean or median values.
In survival analysis, survival time (in this study, time to recurrence) is not known
for all participants at the end of the follow-up data collection period, either because
of failure of the event to occur (i.e. the ulcer did not recur), or because of loss to
follow-up (e.g. deterioration in health requiring withdrawal from the study). Cases
who had not suffered an ulcer recurrence prior to their final data collection or who
had withdrawn or were lost to follow-up from the study prior to 12 months were
censored. Characteristics of participants who were censored prior to the 12 month
study duration and those of participants who did withdraw prior to completion of the
study were compared and no significant differences were found.
Univariate outliers were checked against the raw data for accuracy. Ulcer area
and ulcer duration were log transformed to reduce skewness and kurtosis and
obtain a more normal distribution. Extreme outliers in other variables were checked
for accuracy and retained with their values replaced with median values to reduce
the deviance and thus any impact on causing errors (Tabachnick & Fidell, 2007).
Data analysis
Data were analysed with SPSSv15 (SPSS Inc., Chicago Il). Scale total scores
were calculated from the scale items for the MNA-SF, SF-12v2, Geriatric
Depression Scale, MOS Social Support Survey, General Self-Efficacy scale and the
three YPAS subscales (Total Time Index, Energy Expenditure Index, Total Activity
Index). A variable to indicate those who scored ‘at-risk’ of nutritional deficiency
(scores of 11 or less) was calculated from the MNA-SF scores (Rubenstein et al.,
2001). Body Mass Index (BMI) was calculated from weight and height measures.
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A number of continuous variables were grouped for analysis to enable easier
interpretation of results. As before, BMI scores were grouped to those >27, those
from 23 – 27, and those ≤2 2, i.e. overweight, normal or underweight groups to aid
understanding and applicability of results. Duration of the previous ulcer was
grouped into ulcers of less or more than 24 weeks duration, as ulcers of over 24
weeks duration have been reported in previous research studies to be a significant
predictor of healing and recurrence (Chaby et al., 2006b; Franks et al., 1995b). The
Class 2 and Class 3 compression hosiery groups were combined as the small
number of participants wearing Class 3 hosiery (n=10) did not allow comparisons
between Class 2 and Class 3 compression hosiery, therefore comparisons were
made between participants not wearing any compression hosiery, participants
wearing Class 1 hosiery and those wearing Class 2 or Class 3 hosiery. With regard
to adherence to wearing compression, the data were grouped into those who wore
compression for more or less than five days per week, based on data from the
retrospective study.
Frequency histograms, normal probability plots and detrended expected normal
probability plots were run in SPSS on all continuous variables to check for normality
of distribution and homoscedasticity, to guide descriptive and bivariate analyses.
Although survival analysis does not have assumptions about distributions,
multivariate normality, linearity and homoscedasticity may improve power
(Tabachnick & Fidell, 2007). A test for Mahalanobis distances was undertaken in
SPSS for multivariate outliers, and scores ranged from 2.2 – 19.9, which were less
than the critical value of Chi squared with 8 degrees of freedom (26.125).
The Cox proportional hazards regression model assumes proportionality of
hazards and absence of multicollinearity. To test for proportionality of hazards, plots
of the survival curves for each covariate were computed to allow a visual check that
the curves were approximately parallel. In addition, the assumption was tested
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within SPSS by computing a time variable and examining whether relationships
between time and survival rate remained similar for each level of the covariates
(Tabachnick & Fidell, 2007). Tests for all covariates entered in the model found the
assumption was met.
Multicollinearity checks were initially undertaken using a correlation matrix and
examining Pearson or Spearman coefficients, and checking squared multiple
correlations among covariates. As the three YPAS summary indexes were highly
correlated, only the YPAS Total Activity Index was included in the model. The
highest correlation from the remaining variables was between self efficacy and
social support (Pearson correlation = 0.63).
Descriptive analyses were undertaken for all variables. A survival analysis
approach was taken to determine relationships between preventive activities,
psychosocial factors and recurrence. Survival analysis techniques examine the
length of time to an event (in this case, ulcer recurrence) and can determine
relationships between predictor variables and the time to recurrence (Tabachnick &
Fidell, 2007). It has been recommended that all studies assessing leg ulcer
recurrence utilise survival rate analysis methods (Nelson et al., 2000). Median time
to recurrence was calculated using the Kaplan-Meier method and log-rank test.
A Cox proportional hazards regression model was used to adjust for potential
confounders and analyse the variables’ independent influence on recurrence. Model
fit statistics, significance tests, regression coefficients and hazard ratios were
calculated for the covariates to determine the degree of influence each variable had
on recurrence outcomes.
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Results and Discussion
An article reporting results from the prospective study has been submitted and
accepted subject to minor revisions – ‘Relationships between preventive activities,
psychosocial factors and recurrence of venous leg ulcers: A prospective study’,
Journal of Advanced Nursing, accepted subject to minor revisions 5/02/2010,
Manuscript ID JAN-2009-0895. A copy of the submitted article is provided in the
following Section. As with the first article from the retrospective study (Chapter 3),
this article discusses relationships between physiological, psychosocial and self
care activities influencing recurrence of venous leg ulcers, this time within a
prospective study design. Overall the model was significant - goodness of fit of
model: χ2 = 97.9, p <0.001; with an R2 equivalent = 0.72. A copy of the submitted
article is provided in the following Section.
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Conclusion
This study aimed to determine relationships between the risk of leg ulcer
recurrence and demographic, health, physiological, psychosocial and preventive
strategy variables. With regards to demographic and health variables, only gender
and a history of a previous deep vein thrombosis remained significantly associated
with time to recurrence in the survival regression model. However, there were strong
relationships between recurrence and the psychosocial factors of self efficacy and
social support, in addition to the preventive activities of leg elevation and wearing
compression hosiery. The findings from the study provide information on the
proposed relationships between the independent variables and recurrence shown in
the conceptual model in Chapter 2 (Figure 3). A comparison of results from Study
One and Study Two and their contribution to the conceptual model are discussed in
Chapter Six.
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CHAPTER 6
OVERVIEW AND DISCUSSION
This chapter will review the results obtained from both the retrospective and
prospective studies and discuss their contribution to current knowledge and to the
conceptual model for management of chronic venous insufficiency.
Overview of Results and Contribution to Current Knowledge
The aim of this research was to determine the relationships between leg ulcer
recurrence and demographic, health, physiological, psychosocial and self-care
activity variables. The study was undertaken in two stages: a retrospective study of
participants whose ulcers had healed from 12 to 36 months previously; and a
prospective study of participants recruited as their ulcer healed and followed for 12
months. The over-arching research questions were:
1. Do recurrence rates vary according to demographic or health variables?
2. What is the relationship between recurrence and level of physical activity?
3. What is the relationship between recurrence and psychosocial variables?
4. What is the relationship between recurrence and self care activities
(specifically compression therapy and leg elevation)?
5. Does adherence to self-care activities (specifically wearing compression
hosiery) vary according to demographic, health or psychosocial variables?
6. What are the independent relationships between recurrence and
demographic, health, physical, psychosocial and self-care activity variables
after adjusting for all variables and potential confounders in multivariable
regression models?
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Overview of results in relation to the research questions
Demographics, health and recurrence
After mutually adjusting for all independent variables and potential confounders,
analysis of data from the retrospective study did not find any significant relationships
between demographic variables and recurrence; however, the prospective study
found that men were significantly more likely to recur than women. This may have
been an artefact relating to the smaller sample available for the prospective study.
There were no significant differences found in the reported levels of self-care
activities or psychosocial characteristics between men and women in the
prospective study sample. However, not statistically different but approaching
significance, a greater proportion of men in the prospective study sample were
employed compared to the women, who were more likely to be on a pension. This
factor may have impacted on their self-care activities and/or time spent on their feet.
Differences in recurrence rates according to gender have generally not been
reported previously in the literature, although Margolis et al.’s (2002) prevalence
study found incidence rates for venous leg ulcers were higher in men in the over 85
years age groups.
Only a couple of health or comorbidity variables were found to be significantly
related to recurrence after adjustment for all variables. These were not consistent
between the two studies: a history of cardiac disease was related to recurrence in
the retrospective study; while in the prospective study a history of a deep vein
thrombosis was a significantly related with recurrence. The finding that a previous
deep vein thrombosis is related to higher rates of recurrence is consistent with the
literature on risk factors for recurrence (Abbade & Lastoria, 2005; Franks et al.,
1995c; McDaniel et al., 2002; Moffatt & Dorman, 1995). A history of cardiac disease
as a risk factor for recurrence has not been reported in the literature and this factor
159
was not significant in the prospective study results. However, it is known that
patients with poor cardiac function often have dependent oedema in their lower
limbs, which is likely to exacerbate any oedema resulting from venous insufficiency
and lead to a greater likelihood of recurrence. The difference in results may be
related to participant sample demographic characteristics. Although both the
retrospective study sample and prospective study sample had similar numbers of
participants with cardiac disease (27% and 30% respectively), the median age for
the retrospective study was somewhat older than the participants in the prospective
study, thus it is possible that participants in the retrospective study sample may
have had greater severity of cardiac disease.
Physical activity and recurrence
The level of physical activity was found to be independently significantly related
to the risk of recurrence in the retrospective study, and approached statistical
significance in the prospective study. Both studies found an important clinical
difference in recurrence rates for participants who had high levels of physical activity
in comparison to those with low levels. Foot and calf muscle exercises are often
recommended to prevent venous leg ulcer recurrence, although there is little
evidence to support the strategy or to guide the optimal amount or type of exercise.
There have been conflicting reports on the impact of physical mobility on recurrence
(Barwell et al., 2000a; Brooks et al., 2004; Vowden & Vowden, 2005), however, a
randomised trial found restricted ankle movement was a risk factor for recurrence
(Nelson et al., 2006), and it has been found in previous studies that impaired
mobility is associated with a greater risk of occurrence of venous leg ulcers (Dix et
al., 2003; Moffatt et al., 2006) and of not healing in active venous leg ulcers (Barwell
et al., 2001; Chaby et al., 2006b; Iglesias et al., 2004; Milic et al., 2009a; Vowden et
al., 1997).
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The measure of physical activity in the studies reported in the literature has been
broad, looking at whether the participants were physically disabled or not, or
whether there was restricted range of ankle movement. This study has been able to
provide for the first time a measure of the level of physical activity undertaken prior
to recurrence (i.e. hours of physical activity/week, and type of physical activities, as
provided in the YPAS measures), evidence to suggest physical activity can assist in
the prevention of recurrence, and an indication of how much increased activity was
undertaken by the participants who did not recur in comparison to those who did
recur. This information will be valuable to guide future recommendations on the level
of physical activity required to prevent recurrence.
Psychosocial variables and recurrence
With regard to the relationships between psychosocial variables and recurrence,
self-efficacy (as measured with the General Self-Efficacy scale) was found to be
strongly independently related to recurrence in both the retrospective and
prospective studies. There are no reports in the literature of relationships between
self-efficacy and recurrence in patients with chronic venous insufficiency, and the
lack of a disease specific self-efficacy tool possibly plays a part in the lack of
knowledge in this area. Results from this research program contribute to the
currently available literature on factors influencing outcomes in this population and
suggest that self-efficacy should be considered for inclusion in both future studies in
the area and in interventions for management of chronic venous insufficiency.
Social support was also found to be a significant independent influence on
recurrence in the prospective study, although not in the retrospective study. There
was wide variation in social support scores in the retrospective study which may
explain the lack of a statistically significant difference, although participants who did
not recur still recorded higher average scores (more social support) than those who
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did recur. Poor social support has been previously identified as associated with the
presence of chronic leg ulcers (Moffatt et al., 2009a; Moffatt et al., 2006), and a
small study by Wissing et al. (2001) found patients with higher social interaction
scores were less likely to suffer recurrence. The results from the prospective study
support their findings.
Self care activities and recurrence
Both the retrospective and prospective studies found the self care activities of leg
elevation and wearing compression hosiery were significantly related to preventing
recurrence after adjusting for all variables in the models. Compression hosiery is
currently the primary strategy to prevent recurrence of venous leg ulcers and the
studies’ findings support Nelsen et al.’s systematic review (2000), which found weak
evidence to support the use of compression for prevention, although there was little
information available on the optimal type or level. A more recent trial found no
difference in recurrence rates between those wearing Class 2 or Class 3
compression hosiery (Nelson et al., 2006). The current study adds to knowledge in
this area by providing information on recurrence rates according to differing levels of
compression and information on the optimal number of days/week wearing
compression hosiery.
Leg elevation was the second self care activity which was significantly related to
recurrence in both the retrospective and prospective studies, and was the variable
accounting for the largest proportion of variance in both studies. Although regular
leg elevation (above the level of the heart) is recommended in current best practice
guidelines for patients with chronic venous insufficiency (Arrol et al., 1999;
Registered Nurses' Association of Ontario (RNAO), 2004; Royal College of Nursing,
2006; Stacey et al., 2002), there is very little evidence of its effectiveness in
preventing recurrence in the literature, with the exception of one study of an
162
educational intervention, which found significantly reduced recurrence rates in the
group reporting greater time spent with legs elevated (Brooks et al., 2004). This
study is able to contribute further support for the value of leg elevation in preventing
recurrence and also provide a measure of the average time/day of leg elevation
associated with lower rates of recurrence.
Adherence to self care activities
As self care activities were found to be strongly related to recurrence, an analysis
of the relationships between demographic, health and psychosocial variables and
adherence to self care activities was undertaken to gain a broader understanding of
factors impacting on recurrence. The self care activity chosen for this exploration
was wearing compression hosiery, as this is the most widely accepted and
recommended strategy to prevent recurrence. After controlling for potential
confounders, analysis found no significant relationships between the time spent
wearing compression hosiery and demographic, health or social variables, however,
knowledge, depression and self-efficacy were significantly related to the number of
days/week participants wore compression hosiery.
The findings on depression and knowledge are consistent with previous studies
on compression treatment and venous leg ulcers, where one or both of these factors
are reported as influencing concordance with treatment, including compression
therapy (Chase et al., 2000; Edwards, 2003; Flanagan et al., 2001; Moffatt et al.,
2009b; Nelson, 2005). Self efficacy has generally not been examined in studies of
patients with chronic venous insufficiency, however, self efficacy has been reported
as strongly related to self care activities for other chronic diseases (Brody et al.,
2006; Buszewicz et al., 2006; Jeon & Kim, 2006; Sousa et al., 2004) and this study
adds new information on the importance of self efficacy in self management of
chronic venous insufficiency.
163
Overall View
Looking at the overall results, there were four consistent predictors which were
significantly related to recurrence in the results from both studies: leg elevation,
compression therapy, self efficacy and physical activity. These four variables
explained the greatest amount of variance in both studies, with leg elevation and self
efficacy the strongest predictors. Importantly, analysis of data from the two studies
identified similar results, with the four variables above strongly related to recurrence
in both studies. The regression models in both studies were highly significant and
accounted for approximately 60 – 70% of the variance.
Previously, there has been an absence of studies that combine both
physiological and psychosocial factors when examining recurrence. Results from
these research studies highlight the fact that psychosocial factors such as self
efficacy and social support are as equally important to recurrence outcomes as
physiological factors. Contributions to current knowledge in this area include new
information on the significant relationships between self efficacy and recurrence, leg
elevation and recurrence, the level and frequency of compression therapy and
recurrence, the level and type of physical activity and recurrence, and the
relationships between adherence to compression therapy and depression,
knowledge and self efficacy. Importantly, the primary predictors of recurrence in
these models – self efficacy and the self care activities of leg elevation, compression
and exercise - are amenable to clinical interventions. This information is valuable for
patients and health professionals in providing guidance for programs to prevent
recurrence in patients with chronic venous insufficiency.
164
Contribution of Results to Conceptual Framework
The conceptual framework described in Chapter 2 (Figure 3) was developed by
combining aspects of a model of chronic wound management (Popoola, 2003a); and
a model of chronic disease management (Grey et al., 2006), based on social
cognitive theory. Social cognitive theory examines the concepts of self care
behaviours, self efficacy and environmental impediments and/or facilitators to study
relationships between individuals, health behaviours and their environment
(Bandura, 2004; Nutbeam & Harris, 2004). Individual factors, behaviours and
environmental factors are believed to be all interacting and continually influencing
each other (Bandura, 1989).
Within the network of possible interactions in the proposed conceptual framework
(Fig. 3), the focus of this research was contained to: a) explore the relationships
between recurrence of venous leg ulcers and demographic, physiological,
psychosocial and self care activity variables; and b) explore the impact of
demographic and psychosocial factors on self care activities, specifically wearing
compression hosiery, to prevent recurrence. The model proposed relationships
between a number of physiological, socio-economic/demographic, self care
activities, psychological factors and leg ulcer recurrence, in addition to relationships
between physiological, socio-economic/demographic and psychological factors and
self care behaviours.
Results support the proposed associations between recurrence and a number of
physiological factors, psychosocial factors and self care activities, as shown in
Figure 4. Surprisingly, many of the proposed relationships between demographic
and socio-economic variables were not supported by the results of these studies,
with the exception of a relationship between gender and recurrence in the
prospective study. Some of the socio-economic variables were complex to measure,
165
which may explain the lack of association. For example, although the Australian
Socio-Economic Indexes for Areas (SEIFA) codes were used to look at socio-
economic status, it is difficult to detect SES differences in a population of older
people where occupation and education measures are not always appropriate. The
source of income was examined in relation to recurrence and a difference in
outcomes was suggested at the bivariate level, however, the numbers in some
groups of this variable (e.g. those in employment) were very small and excluded the
variable from inclusion in the regression model. Similarly, the type of health care
was also recorded, i.e. the frequency of follow-up visits to health professionals after
healing and the type of health service or health professional visited, and a difference
noted at the bivariate level on the frequency of follow-up care and adherence to
wearing compression hosiery. However, it was not feasible to test this in the
regression models due to the number of variables.
The proposed relationships between self care behaviours and physiological,
socio-economic/demographic and psychological factors were also examined.
Results supported the importance of self efficacy, knowledge and depression in
relation to adherence to the self care activity of wearing compression hosiery (see
Figure 4). There was no support for relationships between adherence to wearing
compression hosiery and demographic, socio-economic and physiological factors,
despite participants’ reports of physical impairments limiting their ability to apply
compression. It is possible that participants with limited mobility and/or multiple
comorbidities were more likely to receive help in application of their hosiery from
community nurses or carers.
166
Figure 4 Framework for Assessment and Management of Chronic Venous Insufficiency
A. Direct influence on recurrence B. Indirect influence on recurrence via influence on self care activities
DEMOGRAPHICS: Gender
PSYCHOSOCIAL FACTORS: Social support Self-efficacy Depression Knowledge
Self care activities:
Compression
Leg elevation
Recurrence
PHYSIOLOGICAL FACTORS: Cardiac disease
Deep vein thrombosis
Physical activity
167
Self efficacy is believed to be an important determinant of health behaviour in
social cognitive theory (Bandura, 2004) and results from this research support this
theory with regard to self care behaviours for management of chronic venous
insufficiency. Analyses from both studies found self efficacy had both a direct
association with recurrence and a mediating effect through its influence on self care
activities, highlighting the importance of self efficacy in the management of this
chronic disease (Fig. 4). Personal and situational impediments are also considered
to influence health behaviours, such as the presence of depression, which was also
found to be significantly related to self care behaviours in this study. Other
determinants of health care behaviours, such as outcome expectations or beliefs,
were not measured in this study as the primary focus was on recurrence outcomes
and sample size constraints limited the number of variables.
The conceptual framework based on social cognitive theory was thus found to be
appropriate for study of recurrence outcomes in adults with chronic venous
insufficiency, as the framework’s proposed relationships between self efficacy,
individual psychosocial and physiological factors, self care behaviours and chronic
disease outcomes were supported by the results from both the retrospective and
prospective studies. Use of the framework has demonstrated that in addition to
wound specific variables known to be risk factors for recurrence (e.g. previous ulcer
duration, size, history of deep vein thrombosis), many physical, psychosocial and
self care activity factors are extremely important in the prevention of recurrence of
venous leg ulcers.
168
Strengths and Limitations
The strengths of the research include the following elements. There have been
no previous studies controlling for psychosocial factors and level of physical activity
in addition to demographic and health variables when looking at the relationships
between preventive activities and recurrence of leg ulcers. The two designs ensured
results from the retrospective study were available to guide selection of variables for
the regression model tested in the prospective study. It is rare to find a combination
of retrospective and prospective studies in this area. A good response rate for the
retrospective study and adequate samples sizes for both the retrospective and
prospective studies were achieved. Again in this area of study, sample sizes are
often small which compromises the ability to undertake multivariate analyses. In
addition, the studies used validated instruments to measure physical activity and
psychosocial factors and participants were recruited from multiple settings, including
hospital outpatient departments, community clinics and community home settings, to
provide a representative sample. The recruitment strategies also ensured that the
sample was representative of those who receive treatment for venous leg ulcers.
There are also a number of limitations associated with these studies. Due to
funding and health system constraints, data were unavailable on the type or degree
of venous insufficiency, which may also influence recurrence. Measures of physical
activity, psychosocial scales and self-care activities were obtained from self-report
questionnaires, with the possibility of response bias. Small numbers in some
variable categories (i.e. source of income, some comorbidities) limit the reliability of
results for those variables. The limitations of a retrospective study design are
associated with the first study, i.e. reliance on participants’ memory of events and
the possibility of recall bias, and the questionnaire data for the retrospective study
recorded psychosocial measures at the time of the survey rather than prior to any
169
recurrences. However, this limitation was reduced by conducting the prospective
study which then enabled data triangulation between the two studies.
Recommendations
Clinical practice
Results from these studies provide information for clinicians on risk factors for
recurrence and potential strategies for prevention of recurrence in patients with
chronic venous insufficiency. The findings highlight the importance of chronic
disease self care behaviours and the factors which influence these behaviours,
suggesting that patients with chronic venous insufficiency should be treated and
managed with a holistic perspective in a similar manner to other chronic conditions
(e.g. diabetes), rather than with a narrow focus on the venous disease itself.
Patients with venous leg ulcers are frequently treated until the ulcer is healed,
provided with compression hosiery and then discharged. This research highlights for
clinicians the importance of comprehensive long term management and preventive
treatment for this condition.
As the highest rates of recurrence were found within the first three to six months
from healing, patients may benefit from close follow-up care over this time period.
Findings suggest that patients with a past history of a deep vein thrombosis, a
comorbidity of cardiac disease and/or male patients may be at greater risk of
recurrence and therefore require careful follow-up care and close monitoring. In
addition, patients should be screened for depression and social support and
appropriate interventions commenced as necessary. A program of preventive
strategies including daily use of compression therapy, daily leg elevation, walking or
ankle exercises, education on chronic venous insufficiency and strategies to
improve self-efficacy is recommended for this population.
170
Education
Education for health professionals and consumers should include information on
the high rates of recurrence, risk factors for recurrence and the significance of
lifelong chronic disease management strategies for patients with chronic venous
insufficiency. In addition, education on prevention of recurrence of venous leg ulcers
could encompass the importance of self efficacy, leg elevation, compression therapy
and exercise. It is recommended that all health professionals involved in providing
wound care or care for older adults in any setting have this education available
through a variety of sources, such as inclusion in postgraduate courses, continuing
education or inservice sessions or modules, and current evidence available in the
literature and online resources.
Patients suffering from venous leg ulcers and their families or carers need
education to understand their condition, along with brochures or booklets explaining
and promoting effective preventive strategies such as leg elevation, exercise and
compression hosiery. In light of the importance of self efficacy in these results, it is
recommended that education resources and programs for consumers be based on
self efficacy theory, focusing on the four sources of self efficacy – mastery
experience, vicarious learning, verbal or social persuasion and physiological or
emotional responses (Bandura, 1977).
Research
Additional multisite prospective studies with larger numbers and a longer follow-
up time are required in order to identify the broad range of factors associated with
recurrence over the first few years following healing and to identify influences on
adherence to self care activities over a longer period of time. Findings from these
studies suggest experimental studies are now needed to test the model examined in
these studies. Interventions requiring experimental testing include leg elevation
171
(including evaluation of optimal frequency and length of time), lower limb exercises
(e.g. effectiveness of walking in comparison to specific calf strengthening exercises,
or ankle exercises for those with disabilities who are unable to walk), strategies to
promote self efficacy (e.g. education strategies and chronic disease management
programs based on concepts of self efficacy as above), strategies to promote social
support and mental health (e.g. effectiveness of models of care promoting peer
support and social support), and multifaceted interventions combining education and
some of these strategies.
Conclusion
The aim of this research was to identify factors associated with recurrence of
venous leg ulcers. The high rates of recurrence found in the studies highlight the
urgent need for more information in this area to enable development of effective
strategies for prevention. These studies analysed both physiological and
psychosocial influences on recurrence and found psychosocial factors were equally
important as disease or physiological factors. In addition, self care activities
undertaken to prevent recurrence were themselves influenced by psychological
factors. Results obtained from both the retrospective and prospective studies found
four consistent predictors significantly related to recurrence: leg elevation,
compression therapy, self efficacy and physical activity. Importantly, these
predictors are amenable to clinical interventions and provide important information
for health care professionals, patients and families for the development of preventive
strategies. The findings on the associations between self efficacy and recurrence,
leg elevation and recurrence, the level and frequency of compression therapy and
recurrence, and the level and type of physical activity and recurrence contribute
important new information to current knowledge in the area of management of
chronic venous insufficiency.
172
Analysis of data to test relationships in the proposed conceptual framework found
results supported significant relationships between recurrence and physiological
factors, psychosocial factors and self care activities, while the proposed
relationships between demographic and socio-economic variables were generally
not supported. Conceptual framework relationships between self care behaviours
and physiological, socio-demographic and psychological factors were also tested
and results supported the importance of self efficacy, knowledge and depression to
adherence to the self care activity of wearing compression hosiery, however did not
support relationships between adherence to wearing compression hosiery and
demographic, socio-economic and physiological factors. The conceptual framework
incorporated social cognitive theory and results from this research support this
theory with regard to the significant influence of self efficacy and personal
impediments on self care behaviours for management of chronic venous
insufficiency.
In conclusion, this research has identified a conceptual framework for
management of chronic venous insufficiency and a range of factors significantly
associated with recurrence of venous leg ulcers. It is recommended that these
factors are targeted for further investigation and inform preventive strategies for
patients with chronic venous insufficiency.
173
Appendix A
Survey Instruments
Chart Audit Tool
Code No.
Age
Suburb
Income
Marital Status Single Married Divorced Widowed
Living Arrangements Alone Family Other Is primary carer
Services Community Nursing Home Help Other
Height
Weight Comorbidities / medical history
Medications
venous insufficiency: type and degree
Venous surgery
DVTs
Date last ulcer healed
Duration of last ulcer
Size of last ulcer
Previous leg ulcers
Compression prescribed after healing
Level:
Type:
Other treatment prescribed on healing
Follow-up health care arrangements
174
Survey Instruments
Section A. (History and self care activity questions)
1. When did you experience your first leg ulcer?
Less than 6 months ago 6 – 12 months ago
1 – 2 years ago 3 – 5 years ago
5 – 10 years ago Over 10 years ago
2. Have you experienced more than one leg ulcer? Yes No
If you answered YES, how many times have you had a leg ulcer?
2 or 3 4 to 6
7 to 10 Over 10 times
3. Please tick as many boxes as apply. Was your leg ulcer(s) caused by:
Circulation or blood flow problems Skin problems eg. eczema
Problems with the arteries Diabetes
Problems with the veins Not sure
Other (please state) ____________________________________________
4. After your last leg ulcer healed, were you advised to wear compression hosiery, socks or bandages?
Yes No
If you answered no, please go straight to Question 9.
If you answered yes, please proceed to Question 5.
5. How often do / did you wear your compression hosiery, socks or bandages?
Every day up until the present day Every day until a new ulcer occurred
Nearly every day (5 or 6 days/week) Three or four days / week
One or two days /week One day / fortnight or less
Other (please explain) _________________________________________________________________
175
7. What type of hosiery, socks or bandages were prescribed? (eg. brand name, Class, if known) _________________________________________________________________
8. If you wear compression hosiery or socks, how often do you replace the hosiery or socks?
Every three months Every six months
Once / year Less than once/year
9. Do you take any special measures to protect the skin on your lower legs? (Please tick all the boxes that apply to you)
Yes, I regularly apply moisturiser or skin care products
Yes, I avoid drying or irritating substances on skin
Yes, I keep legs covered to avoid scratches/bumps
No Other (please state) ___________________________________
10. Do you spend time (lasting at least 30 minutes) during the day resting with your legs raised above the level of your heart?
No, not at all
Yes, only once / week or less
Yes, 2 or 3 times / week
Yes, 4 – 6 times / week
Yes, once or twice / day
Yes, three or four times / day Approximately how many minutes/day would you rest with your legs elevated? ________________________________________________________________
11. a) Do you do any ankle or leg exercises, like ankle circling or walking?
No, not at all
Yes, once / week or less
Yes, 2 or 3 times / week
Yes, 4 – 6 times / week
Yes, at least once / day b) How many minutes would you usually spend doing this exercise? __________________________________________________________
176
12. Do you currently have a leg ulcer? Yes No
If you answered YES to Question 12., (that is, you currently have a leg ulcer), please answer Questions 13 & 14, otherwise proceed straight to Question15. 13. How long has the current leg ulcer been present?
Less than one month 1 – 3 months
3 – 6 months 6 – 12 months
Over a year 14. If you have a leg ulcer now, how long after your previous ulcer healed was it before this one occurred? (please place a cross on the time line)
Please proceed to Question 17.
15. If you do not currently have a leg ulcer, how long has it been since your last leg ulcer healed? (please place a cross on the time line)
16. If you do not currently have a leg ulcer, how often do you go for a check up for your legs?
Every three months
Every six months
Once / year
Less than once/year
17. Where do you go for check ups for your legs?
Your local doctor
Hospital outpatient clinic
Specialist (eg. vascular physician)
Community Nurse home visit
Community Nursing leg clinic
Other (please state) __________________________
3 years 2 ½ yrs
2 years 1 year 1 ½ yrs
9 mths
6 mths
3 mths
Ulcer Healed
3 years 2 ½ yrs
2 years 1 year 1 ½ yrs
9 mths
6 mths
3 mths
Previous Ulcer
Healed
177
18. Are there any other activities or precautions you take to avoid another leg ulcer?
Yes No
If Yes, please describe: ________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
178
179
180
181
182
183
184
185
186
Appendix B
Statements of Contribution of Co-Authors for Thesis by Published
Papers
187
188
189
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