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Diabeticfootulcer

Updated2015Apr2303:58:00PM:honeydressingmayhavesimilarhealingratecomparedtosalineorpovidoneiodinedressinginpatientswithdiabeticfootulcer(CochraneDatabaseSystRev2015Mar6)viewupdate Showmoreupdates

RelatedSummaries:Diabetes(listoftopics)Diabetesmellitustype1Diabetesmellitustype2inadultsDiabeticneuropathyPhysicianQualityReportingSystemQualityMeasures

Description:

Types:

GeneralInformation

ulcerationinfootofpatientwithdiabetesulcermaybeduetoneuropathy,pressure,ischemia,orvenoushypertension(2)

presenceofulcerisamajorpredisposingfactorfordiabeticfootinfection,butdoesnotguaranteepresenceofinfection(1)

InfectiousDiseasesSocietyofAmerica(IDSA)andInternationalWorkingGroupontheDiabeticFootclinicalclassificationofdiabeticfootinfection(1)

IDSAclassification:Uninfected(PEDISgrade1)woundwithoutpurulenceoranyevidenceofinflammation(localswellingorinduration,erythema,localtendernessorpain,localwarmth)

IDSAclassification:Mildinfection(PEDISgrade2)localinfectionwithwoundlimitedtoskinorsuperficialsubcutaneoustissuewithpresenceof2signsofinflammation(purulence,erythema,painortenderness,warmth,orinduration)and,iferythema,mustbe>0.5cmto2cmaroundulcerexcludingothercausesofinflammatoryresponsesoftheskin(suchas,gout,Charcotneuoosteoarthropathy,fracture,thrombosis,orvenousstasis)

IDSAclassification:Moderateinfection(PEDISgrade3)localinfection(asabove)with>2cmofsurroundingerythemaorwoundinvolvingdeeperstructuresthanskinandsubcutaneoustissue(suchas,osteomyelitis,abscess,fasciitis,septicarthritis)intheabsenceofsystemicinflammatoryresponsesigns

IDSAclassification:Severeinfection(PEDISgrade4)localinfection(asabove)PLUSatleast2ofthefollowingsignsofsystemicinflammatoryresponsesyndrome

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Whoismostaffected:

Incidence/Prevalence:

Likelyriskfactors:

temperature>38degreesC(100.4degreesF)or90beats/minuterespiratoryrate>20breaths/minuteorPaCO 12,000or10yearsmalegenderHbA1c>9%ReferenceArchInternMed1998Jan26158(2):157 EBSCOhostFullTextfulltext

somediagnostictestsandphysicalsignsmaysuggestincreasedriskfordiabeticfootulcer

basedonsystematicreviewwithlimitedevidencesystematicreviewof11cohortand5casecontrolstudiesoftestsinpatientswith

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Factorsnotassociatedwithincreasedrisk:

type1ortype2diabetesandsubsequentincidenceoffootulcerationmethodologicqualitywaslimitedoverallwithonly2cohortstudieshavingassessmentblindedtotestbeingevaluatedfactorssignificantlyassociatedwithincreasedriskincluded

peakplantarpressure(6studies)vibrationperceptionthreshold(8studies)transcutaneousoxygentension30dayshistoryofrecurrentfootulcerstraumaticfootwoundperipheralvasculardiseaseinaffectedlimbpreviouslowerextremityamputationlossofprotectivesensationrenalinsufficiencyhistoryofwalkingbarefoot

weightbearingactivitynotassociatedwithincreasedriskweightbearingprogramnotassociatedwithincreaseinfootulcersamongpatientswithdiabeticperipheralneuropathy

basedonrandomizedtrialwithhighdropoutrate79patients>50yearsoldwithdiabeticperipheralneuropathyrandomizedtoweightbearingexercisevs.controlandfollowedfor12monthsweightbearingexercisegroupreceivedlegstrengtheningandbalanceexercises,selfmonitoredwalkingprogramandmotivationaltelephonecallsfromphysicaltherapistevery2weeksduringmonths412allpatientsreceiveddiabeticfootcareeducation,regularfootcareand8sessionswithaphysicaltherapist39%patientscompletedtrialnosignificantdifferenceinrateoffootulcersbetweengroupsReferencePhysTher2008Nov88(11):1385 EBSCOhostFullTextfulltext

dailyweightbearingactivitynotassociatedwithincreasedriskof

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Causes:

Pathogenesis:

History:

Chiefconcern(CC):

diabeticfootulcerbasedonprospectivecohortstudy400patientswithdiabetesandpriorfootulcerreporteddailyweightbearingactivityevery17weeksfor2yearsafteradjustmentforotherfactors,riskoffootulcercomparedtopatientswith5timesincreasedrateofcancerdeath,butinsufficientevidencetodetermineifincreasedrateofnewcancersnosingletypeofcancerimplicatedReferenceFDASafetyReview2008Mar27,FDASafetyReview2008Jun6FDAaddsBOXEDWARNINGonlabelofbecaplermin(Regranex)gel0.01%toreflectincreasedriskofcancermortalityinpatientsusing3tubes(FDAPressRelease2008Jun6)EuropeanMedicinesAgencyrecommendscontraindicationforRegranexinpatientswithanyformofcancer(EuropeanMedicinesAgencyPressRelease2010Feb18PDF)

becaplermin100mcg/ggelmayleadtofasterhealinginpatientswithdiabeteswithchronicneuropathiculcers(level2[midlevel]evidence)

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Antifungalagents:

basedonrandomizedtrialwithallocationconcealmentnotstated382patientswithdiabetesandchronicneuropathiculcers(meanarea2.7cm ,meanduration49weeks)randomizedtobecaplermingel100mcg/g(0.01%)vs.30mcg/g(0.003%)vs.placeboappliedtowoundoncedaily

2

patientsalsohadtissuedebridement,dailydressingchangesandtreatmentofinfectioncomparingbecaplermingel100mcg/gvs.30mcg/gvs.placebo

completehealingat20weeksin50%vs.36%vs.35%(p=0.007for100mcg/gvs.placebo)alltreatmentgroupshadabout30%ulcerrecurrenceratenosignificantadverseeffects

studyfundedbydrugmanufacturerReferenceDiabetesCare1998May21(5):822 EBSCOhostFullTextfulltext

becaplermingelmayimprovehealingofdiabeticulcersoflowerextremitiesbasedonrandomizedtrial118patientswithlowerextremitydiabeticulcersrandomizedtobecaplermingel0.003%vs.placebogelfor20weekscomparingbecaplerminvs.placebo

completehealingin48%vs.25%(p=0.01,NNT5)medianreductioninulcerarea98.8%vs.82.1%(p=0.09)nosignificantdifferencesintheincidenceorseverityofadverseevents

ReferenceJVascSurg1995Jan21(1):71additionofbecaplermingeltomoistureregulatingwounddressingnotassociatedwithstatisticallysignificantimprovementinfootulcerclosure(level2[midlevel]evidence)

basedonsmallrandomizedtrial32diabeticfootulcersrandomizedtobecaplermin0.01%gelvs.nogelallpatientreceivedmoistureregulatingwounddressing(TheraGauze)andtissuedebridementasneedednosignificantdifferencesinwoundclosureat

12weeks(46.2%inbothgroups)20weeks(69.2%withbecaplerminvs.61.5%withnogel)

woundclosurerate(nopvaluesreported)0.41cm /weekwithbecaplermininthistrial2

0.37cm /weekwithnogelinthistrial2

0.24cm /weekwithbecaplermin(historicaldata)2

0.18cm /weekwithsalinemoisteneddressings(historicaldata)2

ReferenceJAmPodiatrMedAssoc2010MayJun100(3):155notforuseinwoundsclosedbyprimaryintention,dosinginstructionsinvolvecalculationofamountofgelbasedonsizeofulcerandsizeoftube(MonthlyPrescribingReference1998Feb:A26)

additionoffluconazoletousualcaremayreducehealingtimefordiabeticfootulcerswithinvasiveinfection(level2[midlevel]evidence)

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Topicaltretinoin:

Lowmolecularweightheparins:

basedonrandomizedtrialwithoutblinding75patients(meanage59years)withfungalandbacterialinfectionsindeeptissuesoffootulcersrandomizedtofluconazole150mg/dayorallyinadditiontousualcarevs.usualcarealoneandfollowedfor34weeksoruntilwoundhealingusualcareincludedsurgicaldebridement,specificantibiotics,reducedweightonfoot,andglycemiccontrolwoundhealingdefinedascompleteepithelializationorskingraftingcomparingfluconazolevs.usualcare

meanwoundhealingtime7.3weeksvs.11.3weeks(p8yearsoldwithfootulcer>3monthsrandomizedtobemiparinvs.placebo

bemiparin3,500units/daygivenfor10daysfollowedby2,500units/dayfor3

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Granulocytecolonystimulatingfactor(GCSF):

Plateletrichplasmagel:

monthsbothgroupsreceivedusualcare

comparingbemiparinvs.placeboulcerimprovementbydigitalphotographyin70.3%vs.45.5%(p=0.035,NNT4,95%CIforNNT243)completehealingat3monthsin35.1%vs.33.3%(notsignificant)similarnumberofadverseeventsbetweengroups

ReferenceDiabetMed2008Sep25(9):1090 EBSCOhostFullText

GCSFmayreduceamputationriskinpatientswithdiabeticfootinfections(level2[midlevel]evidence)

basedonCochranereviewlimitedbyclinicalheterogeneitysystematicreviewof5randomizedtrialscomparingGCSFvs.placeboornoaddedgrowthfactor(control)in167patientswithdiabeticfootinfectionsallpatientsreceivedusualcarewithantibioticsclinicalheterogeneityoftrialsincluded

patientswithvaryingdegreesofinfectionseveritydifferencesinantibioticregimensdifferencesinGCSFpreparations,dosesanddurations

GCSFassociatedwithreducedrateofamputationinanalysisofalltrials

riskratio(RR)0.41(95%CI0.180.95)NNT7112with18%amputationrateincontrolgroup

reducedrateofanysurgicalinterventioninanalysisofalltrialsRR0.38(95%CI0.210.7)NNT410withsurgicalinterventionin35%ofcontrolgroup

nonsignificantimprovementininfectionstatus(RR1.29,95%CI0.991.67)inanalysisof4trialswith140patientsreducedhospitalstay(meandifference1.4days,95%CI2.27to0.53days)inanalysisof2trialswith50patients

nosignificantdifferencesinwoundhealing,durationofantibiotictreatment,andsideeffectsReferenceCochraneDatabaseSystRev2013Aug17(8):CD006810

plateletrichplasmagelassociatedwithincreasedwoundhealinginnonhealingdiabeticfootulcers(level2[midlevel]evidence)

basedonrandomizedtrialwithoutintentiontotreatanalysis72patientswithnonhealingdiabeticfootulcersrandomizedtoplateletrichplasmagelvs.salinegelandfollowedfor12weeksoruntilhealing32patients(44%)excludedfromfinalanalysiswoundhealedin81.3%withplateletrichplasmagelvs.42.1%withcontrolgel(p=0.036,NNT3)afteradjustmentplateletrichplasmagelassociatedwithshortertimetohealing(p=0.0177)ReferenceOstomyWoundManage2006Jun52(6):68

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Chinesemedicine:

plateletrichplasmagelreportedtoimprovehealingofnonhealingulcersin2caseseries(level3[lackingdirect]evidence)

caseseriesof17patients(aged4478years)withcutaneousulcers(4diabetic,11vascular,1posttraumatic,1decubitus)treatedwithplateletgel

completereepithelializationof4ulcers50%reductioninulcersizein11ulcersnoimprovementin2patientsReferenceBloodTransfus2010Oct8(4):237fulltext

caseseriesof49patients(meanage60.6years)with65nonhealingwoundstreatedwithautologousplateletrichplasmaformean3.2applicationsovermean2.8weeks

21werepressureulcers,16werevenousulcersand14diabeticfootulcers97%reportedsomeimprovementReferenceOstomyWoundManage2010Jun56(6):36

additionofChinesemedicinetostandardtherapymightimprovehealingrateindiabeticfootulcers(level2[midlevel]evidence)

basedonsystematicreviewof6lowqualityrandomizedtrialssystematicreviewof6randomizedtrialsevaluatingadditionofChinese(traditionalandherbal)medicineorallytostandardtherapyin439patientswithdiabeticfootulcersstandardtherapydefinedasantidiabetictreatmentwithorwithoutuseofantibiotics,debridementandosteomyelitistreatmentall6trialshadinadequatelydescribedallocationconcealmentandblindingofoutcomeassessorChinesemedicineassociatedwith

greaterulcerhealingrate(RR0.62,95%CI0.390.97)inanalysisof4trialswith286patientsgreaterrateof30%reductioninulcerarea(RR0.81,95%CI0.710.92)inanalysisof3trialswith224patientsfewerpatientswithoutanyimprovement(RR0.34,95%CI0.210.53)inanalysisof6trialswith439patients

adverseeventsincludednausea,epigastricpainanddrymouthReferenceJAlternComplementMed2010Aug16(8):889 EBSCOhostFullTextPDF

ChineseherbalmedicineTangzuYuyangointmentassociatedwithimprovementindiabeticfootulcers(level2[midlevel]evidence)

basedonsmallrandomizedtrial57patientswithchronicdiabeticfootulcersofWagner'sulcergrade13randomizedtotopicalTangzuYuyangointmentplusstandardwoundtherapyvs.standardwoundtherapyaloneandfollowedfor24weeks84%completedtrialcomparingTangzuYuyangointmentplusstandardwoundtherapyvs.standardwoundtherapyalone

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Herbaltreatments:

Othermedications:

Surgeryandprocedures:

ulcerimprovementat12weeksin79.2%vs.41.7%(p=0.017,NNT3)ulcerimprovementat24weeksin91.7%vs.62.5%(p=0.036,NNT4)

nosignificantdifferenceinnumberofulcerscompletelyhealedat4,12,and24weeks,adverseevents,orhealingtimeReferenceJEthnopharmacol2011Jan27133(2):543

Pycnogenolmayimprovesymptomsandhealingrateinpatientswithdiabeticfootulcer(level2[midlevel]evidence)

basedonsmallrandomizedtrial30patientswithdiabeticfootulcerrandomizedto1of4groups

oralPycnogenolpluslocalPycnogenol(combination)localPycnogenolonlyoralPycnogenolonlystandardcare

meanmicrocirculatorysymptomscore(scale010,with0indicatingnosymptoms)2.2pointsincombinationgroup(p

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InfectiousDiseasesSocietyofAmerica(IDSA)recommendations(1)

nonsurgicalcliniciansshouldconsiderassessmentbysurgeonforpatientswithmoderateorseverediabeticfootinfection(IDSAWeakrecommendation,Lowqualityevidence)involvevascularsurgeonearlywheneverischemiacomplicatesdiabeticfootinfection,especiallyinpatientwithcriticallyischemiclimb(IDSAStrongrecommendation,Moderatequalityevidence)refertosurgeonexperiencedwithdiabeticfootinfectionsandadequateknowledgeoffootanatomyifpatientrequirescomplexorreconstructiveprocedures(IDSAStrongrecommendation,Lowqualityevidence)

urgentsurgeryneededformostfootinfectionsaccompaniedbygasinthedeepertissues,abscess,ornecrotizingfasciitis(IDSAStrongrecommendation,Lowqualityevidence)lessurgentsurgeryneededforwoundswithsubstantialnonviabletissueorextensiveboneorjointinvolvement(IDSAStrongrecommendation,Lowqualityevidence)surgicaldebridementincludinglimitedresectionsoramputationsmayreduceneedformoreextensiveamputationssurgicalapproachshouldoptimizelikelihoodforhealingandattempttopreserveintegrityofwalkingsurfaceoffoot

debridedevitalizedandnecrotictissuetodecreasebacterialloadofwoundandpromotewoundhealing(2)

decreasebacterialcontaminationofwoundpriortoattemptingsurgicalclosurewithskingrafting(2)

surgicaldebridementisalsonecessaryforosteomyelitis,earlyandaggressivedrainageanddebridementisnecessaryforlimbthreateninginfectionsamputationmaybenecessarytocontrolsepsisskinreplacementtherapies

skinreplacementtherapiesmightbeeffectivefordiabeticfootulcer(level2[midlevel]evidence)

basedonsystematicreviewofrandomizedtrialswithmethodologicallimitationssystematicreviewof5randomizedtrialscomparingdermalallografts,bioengineeredskingraftsordermalandepidermalautograftstostandardcarefordiabeticfootulcerin792patientsmethodologicallimitationsincluded

allocationconcealmentnotreportedlackofintentiontotreatanalysislackofblindedoutcomeassessment

completeulcerclosurein43.3%forgraftgroupsvs.29.3%forcontrolgroups(p

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Lasertherapy:

basedonpooledanalysisof2randomizedtrialswithoutblinding280patientswithnoninfecteddiabeticfootulcersfor2weekswhowererandomizedtoApligraf(bilayeredcelltherapy)vs.noadditionaltreatmentwereanalyzedallpatientsreceivedstandardtherapy(sharpdebridement,standardwoundcare,andoffloading)competewoundclosurein55.2%ofApligrafpatientsvs.34.4%ofcontrolpatientsby12weeks(p=0.0005,NNT5)ReferenceJAmPodiatrMedAssoc2010JanFeb100(1):73

Achillestendonlengtheningreducesrecurrenceratesfordiabeticfootulcer(level1[likelyreliable]evidence)

basedonrandomizedtrial64patientswithdiabetesmellitusandneuropathicplantarulcerwererandomizedtototalcontactcastpluspercutaneousAchillestendonlengtheningvs.totalcontactcastalonecomparingAchillestendonlengtheningvs.totalcontactcastalone

healingrates100%vs.88%(notsignificant)meanhealingtime58daysvs.41days(notsignificant)ulcerrecurrencewithin7monthsin15%vs.59%(p=0.001,NNT3)ulcerrecurrencewithin2yearsin38%vs.81%(p=0.002,NNT3)

ReferenceJBoneJointSurgAm2003Aug85A(8):1436 EBSCOhostFullTextnoadditionaltrialsfoundinCochraneDatabaseSystRev2013Jan31(1):CD002302

selectiveplantarfasciareleasereportedtoimprovehealingofforefootulcersinpatientswithdiabetes(level3[lackingdirect]evidence)

basedoncaseseries60patientswithdiabetesandforefootulcerfor>3monthsandperipheralneuropathyandnoevidenceofinfectionhadselectiveplantarfasciarelease(SPFR)procedureSPFRtransectsfibersofplantarfascia(alsocalledplantaraponeurosis)thatinsertintoaffectedtoehealingofulcerin

40patientsoverall(67%)bysixweeks7of16(44%)ulcersatmetatarsophalangeal(MTP)joint29of48(60%)ulcersonplantartoe

healingassociatedwithpreoperativedorsiflexionanglebetween5and30(p12%)inadequatelowerextremityperfusionulcertreatmentwithnormothermicorHBOtherapyconcomitantmedicationssuchascorticosteroids,immunosuppressivemedicationsorchemotherapy

allpatientshadstandardoffloadingasneeded335patients(98%)whohadallocatedtreatmentincludedinmodifiedintentiontotreatpopulationcomparingnegativepressurewoundtherapyvs.advancedmoistwoundtherapy

completewoundclosurein43.2%vs.28.9%(p=0.007,NNT7)at112daysfollowupestimatedmediantimetocompletewoundclosurewas96daysforvs.undeterminedfor(p=0.001)secondaryamputationsin4.1%vs.10.2%(p=0.035,NNT17)at6months

nosignificantdifferencesininfections,cellulitisorosteomyelitisat6monthsReferenceDiabetesCare2008Apr31(4):631 EBSCOhostFullTextfulltext,commentarycanbefoundinDiabetesCare2008Oct31(10):e76andEvidBasedNurs2008Oct11(4):116

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Lighttherapy:

Autologousplateletrichplasma:

negativepressurewoundtherapyforpartialfootamputationwoundmayimprovehealingandpreventsecondamputation(level2[midlevel]evidence)

basedonrandomizedtrialwithhighdropoutrate162adultswithpartialdiabeticfootamputationwoundsuptotransmetatarsallevelandadequateperfusionwererandomizedtonegativepressurewoundtherapy(usingvacuumassistedclosuretherapysystem,dressingchangesevery48hours)vs.standardmoistwoundcare(dressingchangeseverydayoratphysiciandiscretion)untilhealingor112days(16weeks)comparingnegativepressurewoundtherapyvs.standardmoistwoundcare

healingin56%vs.39%(p=0.04,NNT6)completewoundclosurewithoutsurgicalinterventionin40%vs.29%22%vs.25%withdrewbeforelasttreatmentvisitwithoutwoundclosuresecondamputationin3%vs.11%(p=0.06)negativepressurewoundtherapyassociatedwithfasterrateofwoundhealing

nosignificantdifferencesinadverseeventscomparinginterventionvs.control52%vs.54%oneormoreadverseevents17%vs.6%adverseeventofwoundinfection12%vs.13%treatmentrelatedadverseevent

ReferenceLancet2005Nov12366(9498):1704 EBSCOhostFullText,commentarycanbefoundinLancet2006Mar4367(9512):725EBSCOhostFullText

visiblelighttherapymightimprovehealingofdiabeticorvenousfootulcers(level2[midlevel]evidence)

basedonsmallcontrolledtrial16patientswithdiabeticfootulcersorchroniclegulcerstreatedwithbroadbandlightsource(400800nm)attherapeuticdose(180mW/cm )vs.placebodose(10mW/cm )twicedailyfor4minutes/session

2

2

at12weeks,completewoundhealingoccurredin9of10(90%)lighttherapypatientsvs.2of6(33%)controlpatients(NNT2)ReferencePhotomedLaserSurg2011Jun29(6):399

autologousplateletrichplasmanotassociatedwithincreasedwoundhealinginadultswithchronicwounds(level2[midlevel]evidence)

basedonCochranereviewoftrialswithmethodologiclimitationssystematicreviewof9randomizedtrialsevaluatingautologousplateletrichplasmain325adultswithchronicwoundsalltrialshad1limitationincluding

allocationconcealmentnotstatedhighlosstofollowuplackoforunclearblindingsmallsamplesize

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FootwearandCasting:

trialsevaluateddiabeticfootulcer(2trials),venouslegulcer(3trials),andmixedchronicwounds(4trials)comparingautologousplateletrichplasmatostandardtreatment(withorwithoutplacebo),nosignificantdifferencesin

completelyhealedwoundinanalysisof7trialswith274adultstotalareaepithelializedinanalysisof3trialswith66adultswoundcomplicationsinanalysisof3trialswith117adults

comparingautologousplateletrichplasmavs.biomaterialin1trialwith34adults,nosignificantdifferenceincompletewoundhealingReferenceCochraneDatabaseSystRev2012Oct17(10):CD006899

offloadpressureoverareaofulcerwithanyof(2)

crutcheswalkerwheelchairspecialshoescustominsertstotalcontactcast

allowscontinuedambulationwhilerelievingpressureatulcersitenotforusewithischemicorinfectedulcersminimalpadding,mostlyfoamaroundforefootmoldedtoshapeoffootandlegrubberheelundermidfootforwalkingremove2448hoursafterapplicationtoassessfit,thenchangecasteveryweekhealinggenerallytakes810weeksslowtransitionfromcasttoshoe,withinterimuseofsandalwiththick,pliantinsoleapplicationoftotalcontactcast

followingdebridementofulceranddrysteriledressinggenerallyrequires2peopleand30minutesfirstruleoutosteomyelitisoruncontrolledinfection

keepfeetclean,butheat,soaksandwhirlpooltherapymaydamagetissueandpromoteinfectionnonremovablepressurerelievingcastsassociatedwithimprovedulcerhealingandmaybemoreeffectivethanremovablepressurerelievingdevicesinadultswithdiabeticfootulcer(level2[midlevel]evidence)

basedonCochranereviewoftrialswithmethodologiclimitationssystematicreviewof14randomizedtrialsevaluatingpressurerelievinginterventionsin709adultswithdiabeticfootulceralltrialshad1limitationincluding

unclearallocationconcealmentlackoforunclearblindingofoutcomeassessorslackofintentiontotreatanalysissmallsamplesize

nonremovablecastassociatedwithincreaseinhealedulcerscomparedto

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Followup:

Complications:

Prognosis:

Woundhealing:

removablecastinanalysisof5trialswith230adultsriskratio1.17(95%CI1.011.36)NNT5150withhealedulcersin67%ofremovablecastgroup

nonremovablecastsignificantlyincreasedulcerhealingvs.dressingalonein2trialswith98adultsfeltfittedtotemporarytherapeuticshoehadborderlinesignificantincreaseinulcerhealingat14weeksvs.feltfittedtofootin1trialwith32adultsnosignificantdifferenceinulcerhealingcomparing

standardnonremovabletotalcontactcastvs.instanttotalcontactcast(removablecastwalkerplusfiberglasscastingmaterial)in1trialwith41adultsremovablecastwalkervs.removablehalfshoein1trialwith50adultstemporarytherapeutichalfshoevs.feltedfoamdressingin1trialwith61adults

ReferenceCochraneDatabaseSystRev2013Jan31(1):CD002302fulltext

priortohospitaldischarge,confirmpatientisclinicallystableandhas(IDSAStrongrecommendation,Lowqualityevidence)(1)

hadanyurgentlyneededsurgeryachievedacceptableglycemiccontrolabilitytomanage(onhis/herownorwithhelp)atdesignateddischargelocationappropriateantibioticregimentowhichpatientwilladhereoffloading(ifneeded)andspecificwoundcareregimensplanforappropriateoutpatientfollowup

reviewofcareofelderlypatientwithlowerextremityamputationcanbefoundinJAmBoardFamPract2000JanFeb13(1):23

ComplicationsandPrognosis

osteomyelitisispotentialcomplicationofanyinfected,deep,orlargefootulcer,especiallyifchronicoroverlyingbonyprominence(1)

sepsisamputation

47%rateofhealingwithin20weeks,morelikelyifsmallwoundofshortduration(level2[midlevel]evidence)

basedonretrospectivecohortstudyrecordsreviewedof27,630patientswithdiabeticneuropathicfootulcersinalargewoundcaresystem12,983(47%)achievedhealingwithin20weeksofcaresimplestprognosticmodelgave1pointforeachof

woundolderthan2monthswoundlargerthan2cm2

grade3on6pointwoundassessmentscale

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likelihoodofwoundhealingby20weeks65%forscoreof053%forscoreof134%forscoreof229%forscoreof3

ReferenceAmJMed2003Dec1115(8):62722%42%healingratesat20weekswithstandardcareregimensdependingonwoundsizeandduration(level2[midlevel]evidence)

basedonmetaanalysismetaanalysisofindividualdataof586patientswithdiabetesandneuropathicfootulcerinstandardcarearmsof5randomizedtrialsallreceived"goodwoundcare,"debridementand"offloading"ofwoundhealingwithin20weekswasmorelikelyifsmallwound,woundofshorterdurationandnonwhiteracehealingratesat12weeksbasedonwoundsizeandduration

woundsize4cm 13.8%2

woundduration12months15.3%woundduration

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Amputationrisk:

ReferenceDiabetesCare2007Aug30(8):2064 EBSCOhostFullTextfulltextposteriortibialpulsebyDopplerexamandpainlessulcerappeartopredictwoundhealing(level2[midlevel]evidence)

basedonsmallcohortstudycohortstudyof64consecutivepatientswithdiabeteswith78footulcers47%healedby6monthfollowuppredictorsoffailuretohealwereabsentposteriortibialpulsebyDopplerexam(oddsratio[OR]8.5)andpainatulcersite(OR3.7)inabsenceofDopplerexam,predictorsofpooroutcomewerepreviousamputationandpainatulcersitemagneticresonanceimaging(MRI)diagnosisofosteomyelitisdidnotpredictfailuretoheal,butonly42patientshadinterpretableMRIReferenceJGenInternMed1997Sep12(9):537fulltext

signssuggestingpossibleimminentlimbthreateninginfectioninclude(1)

rapidprogressionofinfectionextensivenecrosisorgangreneextensiveecchymosesorpetechiaebullae,especiallyhemorrhagicnewonsetwoundanesthesiacriticallimbischemia(decreasingerythema,warmthandinduration)extensivesofttissuelossextensivebonydestruction,especiallymidfoot/hindfootinclinicalsettingwithlessadvancedhealthcareavailable,lesserdegreeofinfectionseveritymayresultinlimbthreateninginfection

riskscorepredictsriskforlowerextremityamputationinpatientswithdiabeticfootinfection(level1[likelyreliable]evidence)

basedonderivationandvalidationcohortstudy2,230patientshospitalizedforculturedocumenteddiabeticfootinfectionwereinderivationcohortand788similarpatientswereinvalidationcohort463(20.8%)patientsinderivationcohortand183(23.2%)patientsinvalidationcohorthadlowerextremityamputationriskfactorsidentifiedinderivationcohortandpointsassignedtoderiveriskscore(totalscore055points)

chronicrenaldiseaseorcreatinine>3mg/dL(265.2mcmol/L)(1point)malegender(1point)temperature38degreesC(100.5degreesF)(2points)age50years(4points)infectedulcer(4points)historyofamputation(4points)albumin11,000/mm (7points)3

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Mortality:

Prevention:

surgicalsiteinfection(10points)transferredfromotheracutecarefacility(12points)

observedlowerextremityamputationrates

Results:

RiskScore DerivationCohort ValidationCohort

0points 0% 0%

14points 4.2% 5.7%

511points 10.7% 11.9%

1220points 25.9% 29.3%

21points 48.6% 49.2%

ReferenceDiabetesCare2011Aug34(8):1695 EBSCOhostFullTextfulltextposttreatmentCreactiveprotein(CRP)levelsmaypredictamputationriskinpatientswithinfecteddiabeticfootulcer(level2[midlevel]evidence)

basedonderivationcohortstudywithoutvalidationcohortprospectivestudyof201patientshospitalizedforinfecteddiabeticfootulcerandfollowedfor6months36patientswithoutregularfollowupvisitswereexcludedfromanalysisof165patientsanalyzed,70(42%)hadamputationforpredictingamputation

posttreatmentCRP30mg/dLhad65%positivepredictivevalueand76%negativepredictivevalueposttreatmentCRP50mg/dLhad71%positivepredictivevalueand73%negativepredictivevalueposttreatmentCRP90mg/dLhad83%positivepredictivevalueand68%negativepredictivevalue

ReferenceJAmPodiatrMedAssoc2011JanFeb101(1):1

diabeticfootulcerassociatedwithincreasedriskofdeathbasedonsystematicreviewof8studiesevaluatingassociationbetweendiabeticfootulcersandmortalityinpatientswithdiabetes3,619deathsoccurredduring81,116personyearsoffollowupcomparedtonodiabeticfootulcer,diabeticfootulcerassociatedwithincreasedriskof

allcausemortality(riskratio[RR]1.89,95%CI1.62.23)fatalmyocardialinfarction(RR2.22,95%CI1.094.53)fatalstroke(RR1.41,95%CI0.613.24)

ReferenceDiabetologia2012Nov55(11):2906 EBSCOhostFullText

PreventionandScreening

AmericanDiabetesAssociation(ADA)footcarerecommendations

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performannualcomprehensivefootexaminallpatientswithdiabetes,including(ADAGradeB)

inspectionofskinintegrityandmusculoskeletaldeformitiesassessmentoffootpulsestestingforlossofprotectivesensation(LOPS)withanyof

10gmonofilamentvibrationthresholdusing128hertz(Hz)tuningforkpinpricksensationanklereflexesvibrationthresholdusingbiothesiometer

patientswithinsensatefeet,footdeformities,andulcersshouldhavefootexamateveryvisit(ADAGradeE)providegeneralfootselfcareeducationtoallpatientswithdiabetes(ADAGradeB)

handoutondiabeticfootcarefromAmericanAcademyofFamilyPhysiciansorinSpanish

multidisciplinaryapproachrecommendedforindividualswithfootulcersandhighriskfeet(suchasdialysispatientsorpatientswithCharcotfoot,priorulcers,oramputation)(ADAGradeB)refertofootcarespecialistforongoingpreventivecareandlifelongsurveillanceforpatientswho(ADAGradeC)

smokehaveLOPShavestructuralabnormalitieshavehistoryofpriorlowerextremitycomplications

initialscreeningforperipheralarterialdisease(PAD)shouldinclude(ADAGradeC)historyforclaudicationassessmentofpedalpulses

ifpositiveanklebrachialindexorsignificantclaudication,referforfurthervascularassessmentandconsiderexercise,medications,andsurgicaloptions(ADAGradeC)forpatientswithneuropathyorevidenceofincreasedplantarpressure(suchaserythema,warmth,callus,ormeasuredpressure)

advisefootwearthatcushionsandredistributespressurecalluscanbedebridedwithscalpelbyfootcarespecialistorotherhealthprofessionalwithexperienceandtraininginfootcarepatientswithbonydeformities(suchashammertoes,prominentmetatarsalheads,orbunions)mayneedextrawideshoesorextradepthshoespatientswithextremebonydeformities(suchasCharcotfoot)mayneedcustommoldedshoes

patientswithdiabetesandhighriskfootconditionsshouldbeeducatedregardingtheirriskfactorsandappropriatemanagement,including

implicationsofLOPSimportanceofdailyfootmonitoring(visualinspectionorhandpalpationifneuropathy)properfootcare(includingnailandskincareandselectionofappropriate

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footwear)patientswithvisualdifficulties,physicalconstraints,orcognitiveproblemsthatlimitabilitytoassessfootstatusandrespondappropriatelywillneedotherpeopletohelpwiththeircareReferenceADApositionstatementonstandardsofmedicalcareindiabetes:microvascularcomplicationsandfootcare(DiabetesCare2015Jan38Suppl1:S58 EBSCOhostFullTextfulltext)

additionalADArecommendationsonpreventivefootcarepatientswithdiabeticneuropathyshouldhavevisualinspectionoftheirfeetateveryvisitwithahealthcareproviderpatientswith1highriskfootconditionsshouldbeevaluatedmorefrequentlythanannuallypatientswithneuropathyshouldbreakinnewshoesgraduallytominimizeformationofblistersandulcersReferenceADA2004policystatementonpreventivefootcareindiabetes(DiabetesCare2004Jan27Suppl1:S63 EBSCOhostFullTextfulltext)

limitedandinconsistentevidenceforinterventionstopreventdiabeticfootulcers

basedonsystematicreviewof12randomizedtrialsevaluatinginterventionsforpreventionofdiabeticfootulcerssurgicalbonedebridementandAchillestendonlengtheningreducedfootulcersinindividualpoorqualitytrialsinconsistentevidenceforpatienteducation(4trials)andtherapeuticfootwearorinsoles(3trials)plantarfoottemperatureguidedavoidancetherapyassociatedwithreduceddiabeticfootulcersininsensatefeetin3trials(2trialsdescribedbelow)ReferenceDiabetesCare2011Apr34(4):1041 EBSCOhostFullTextfulltext

possiblyeffectiveclinicalinterventionsforpreventingfootulcersinpatientswithdiabetes

educatingpatientsaboutproperfootcareperiodicfootexaminationsoptimizingglycemiccontrolsmokingcessationintensivepodiatriccaredebridementofcallusescertaintypesofprophylacticfootsurgeryReferencebasedonsystematicreviewwith22randomizedtrials(JAMA2005Jan12293(2):217 EBSCOhostFullTextfulltext)

patienteducationforpreventingdiabeticfootulcershaslimitedandconflictingevidence

basedonCochranereviewsystematicreviewof12randomizedtrialsevaluatingpatienteducationforpreventingdiabeticfootulcersinadultswithtype1ortype2diabetesmedianfollowup6months(range4weeksto7years)

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metaanalysisprecludedbyheterogeneityininterventionsandoutcomemeasuresfewtrialsreportedclinicalendpointsmixedresultscomparingintensivevs.briefeducationalinterventions

grouppatienteducationsession(1hour)pluspatientinstructionsonfootcaresignificantlyreducedfootulcerincidenceandamputationrateat1yearvs.routinepatienteducationin1trialwith182adults(354limbs)nosignificantdifferencesinfootulcerincidenceandamputationrateat1yearcomparingsingle1hourhomefootcareeducationsessionplustelephonefollowupandhandoutvs.handoutalonein1trialwith172adultsadditionof4weeklygroupeducationsessionstogrouppatienteducationprogram(14hoursover3days)significantlyreducedfootproblemsrequiringtreatmentat1month,butnosignificantdifferenceat6monthsin1trialwith70adults

nosignificantdifferenceinseverefootlesions(ulcers,amputations)at1.5yearscomparingfootcareeducationaspartofgeneraldiabeteseducationprogramvs.usualcarein1trialwith266adultsReferenceCochraneDatabaseSystRev2014Dec16(12):CD001488

foottemperaturemonitoringmayreducediabeticfootulcersinhighriskpatients(level2[midlevel]evidence)

basedonsystematicreviewwithoutassessmentofstudyqualitysystematicreviewof9studies(3randomizedtrialsand6observationalstudies)evaluatingtemperaturemonitoringinpredictionandpreventionofdiabeticfootulcerinpatientswithdiabetes3preventiontrialsincluded,2summarizedbelowfoottemperaturemonitoringassociatedwithincreasedpreventionofdiabeticfootulcersinanalysisof3randomizedtrials(oddsratio3.84,95%CI1.56.17),resultslimitedbysignificantheterogeneityReferenceJFootAnkleRes2013Aug76(1):31fulltextdermalthermometrywasuseofinfraredskintemperaturemeasurementson6sitesonsolesofeachfoottwicedailythermometerusedwasTempTouchthermometer(XilasMedicalIncorporated)

footwearorthosesadjustedforshapeandplantarpressuremaydecreaseriskofrecurrentplantardiabeticfootulcercomparedtostandardorthosesinadults(level2[midlevel]evidence)

basedonrandomizedtrialwithoutintentiontotreatanalysis150adults(meanage60years)withdiabetesandpriorfootulcerwererandomizedtoorthosesadjustedforshapeandplantarpressurevs.standardorthosesandfollowedupto16.5monthsadjustedorthosesmodifiedusingcomputeraideddesignprocessbasedonpeakbarefootplantarpressuredistributioncontours87%receivedfootwearandwereincludedinanalysescomparingadjustedvs.standardorthoses

plantarulcerrecurrencein9.1%vs.25%(p=0.007,NNT7)

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plantarulcerornonulcerativelesionin37.5%vs.45.3%(notsignificant)ReferenceDiabetesCare2014Jul37(7):1982 EBSCOhostFullText

custommadefootwearmightdecreaseriskofdiabeticfootulcerrecurrenceinpatientswithgoodadherence(level2[midlevel]evidence)

basedonsubgroupanalysisfromrandomizedtrialwithlowadherence171patientswithdiabetesandrecentlyhealedplantarfootulcerrandomizedtocustommadefootwearwith20%peakpressurereliefvs.nonimprovedfootwear(control)for18monthsadherence(definedas%stepsinfootwear)70.2%incustommadefootweargroupvs.75.5%incontrolgroup(notsignificant)comparingcustommadefootwearvs.control,footulcerrecurrencein

38.8%vs.44.2%(notsignificant)overall25.7%vs.47.8%(p=0.045,NNT5)inprespecifiedsubgroupanalysisof79patientswith80%adherence

ReferenceDiabetesCare2013Dec36(12):4109 EBSCOhostFullTexttherapeuticfootwearnotshowntopreventfootulcersinpatientswithdiabeteswithhistoryoffootulcer

basedonrandomizedtrial400patientswithdiabeteswithhistoryoffootulcerwhodidnotrequirecustomshoesforfootdeformitywererandomizedto1of3groups

3pairsoftherapeuticshoesandcustomizedmediumdensitycorkinsertswithneopreneclosedcellcover3pairsoftherapeuticshoesandprefabricatedtaperedpolyurethaneinsertswithbrushednyloncoverusualfootwear

2yearcumulativereulcerationratewas14%15%intreatmentgroupsand17%incontrolsbutdifferencesnotstatisticallysignificant88%100%ulcersoccurredinpatientswithfootinsensitivitysubjectshadcloseattentiontofootcarebyhealthcareproviders,soresultsmaynotapplytopatientswithlessattentivecareReferenceJAMA2002May15287(19):2552 EBSCOhostFullTextfulltextcommentarynotingthathalfthesubjectshadintactprotectivesensationandothercriticismscanbefoundinJAMA2002Sep11288(10):1231

insufficientevidencetosupportcomplexinterventionsforpreventionofdiabeticfootulceration

basedonCochranereviewsystematicreviewof5lowqualityrandomizedtrialsevaluatingcomplexinterventionsforpreventionoffootulcersinpatientswithdiabetescomplexinterventiondefinedasintegratedcareapproach,combining2preventionstrategieson2differentlevelsofcare(patient,healthcareproviderand/orthestructureofhealthcare)comparingintensivecomprehensiveinterventionvs.usualcare

nosignificantdifferencebetweengroupsinfootulcersat2yearsin1trialwith2,001patients

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Screening:

lowerextremityamputationsin0.7%vs.2.3%(p=0.0056,NNT65)at2yearsin1trialwith2,001patientssignificantimprovementinvariousselfcarebehaviorsat12monthswithcomprehensiveinterventionin1trialwith83patients

littleevidenceofbenefitin3trialscomparingeducationcenteredinterventionvs.usualcareorwritteninstructionsonlyReferenceCochraneDatabaseSystRev2010Jan20(1):CD007610(reviewupdated2011Oct5)

implementationofguidelines(StagedDiabetesManagement)byprimarycareprovidersassociatedwithdecreasedratesoflowerextremityamputation(level2[midlevel]evidence)

basedonbeforeandafterobservationalstudyin639AmericanIndianswithdiabetesinruralprimarycareclinicReferenceJFamPract1998Aug47(2):127

editorialdiscussionfocusingonlackofsupportingevidenceforstrategiesofpreventionofdiabeticfootulcercanbefoundinBMJ2008Sep3337:a1234 EBSCOhostFullText

screeningfordiabeticperipheralneuropathyAmericanDiabetesAssociation(ADA)recommendations

neuropathyscreeningscreenallpatientsfordiabeticperipheralneuropathystartingatdiagnosisoftype2diabetesand5yearsafterdiagnosisoftype1diabetesandatleastannuallythereafter,usingsimpleclinicaltests(ADAGradeB)electrophysiologicaltestingorreferraltoneurologistrarelyneeded,exceptinsituationswithatypicalclinicalfeaturesscreenforsignsandsymptomsofcardiovascularautonomicneuropathyinpatientswithmoreadvanceddisease(ADAGradeE)

footcareforallpatientswithdiabetes,performannualcomprehensivefootexaminationincluding(ADAGradeB)

inspectionofskinintegrityandmusculoskeletaldeformitiesassessmentoffootpulsestestingforlossofprotectivesensationwithanyof

10gmonofilamentvibrationusing12hertz(Hz)tuningforkpinpricksensationanklereflexesvibrationperceptionthresholdusingbiothesiometer

initialscreeningforperipheralarterialdiseaseshouldincludehistoryforclaudication,assessmentofpedalpulses,andconsideringanklebrachialindex(ABI)(ADAGradeC)

ReferenceADApositionstatementonstandardsofmedicalcareindiabetes:microvascularcomplicationsandfootcare(DiabetesCare2015Jan38Suppl:S58

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EBSCOhostFullTextfulltext)positiveSemmesWeinsteinmonofilamentexamappearstohavegoodpositivepredictivevaluefordetectionofdiabeticperipheralneuropathy(level2[midlevel]evidence)

basedonsystematicreviewofstudiesofvaryingqualitysystematicreviewof30studiesevaluatingSemmesWeinsteinmonofilamentexam(SWME)fordetectionofdiabeticperipheralneuropathywith8,365patientsstudiesusedwiderangeofmonofilamentsizes,numberandsitesoftestinglocations,diagnosticthresholds,andreferencetestsreferencetestsincluded

nerveconductionstudyhistoryofulcerationSanAntonioConsensusEvaluationvibrationthresholdwithbiothesiometerdetailedneurologicalassessmentHoffmanreflextest

diagnosticperformanceofmonofilamentexamcomparedtonerveconduction(referencestandard)in4studieswith1,065patients

rangeofsensitivity57%93%rangeofspecificity75%100%rangeofpositivepredictivevalue(PPV)84%100%rangeofnegativepredictivevalue(NPV)36%94%

thoughnotdirectlystudied,theauthorsrecommendtestingplantaraspectsofgreattoeandthirdandfifthmetatarsalheadstomaximizediagnosticvalueReferenceJVascSurg2009Sep50(3):675fulltextsimilarfindingsinadditionalsystematicreviewofmonofilamenttesting

basedonsystematicreviewwithheterogeneitysystematicreviewof3studiesofaccuracyof5.07/10gmonofilamentindetectionofperipheralneuropathyofanycauseusingnerveconductionasreferencestandardin641patientsstudiesappearedlimitedtopatientswithdiabetesmellitussensitivityrangedfrom41%to93%andspecificityrangedfrom68%to100%metaanalysiscouldnotbeconductedduetoheterogeneityReferenceAnnFamMed2009NovDec7(6):555 EBSCOhostFullTextfulltext

SWMEmaypredictriskoffootulcerationandamputationinpatientswithdiabetesmellitus(level2[midlevel]evidence)

basedonsystematicreviewwithheterogeneityandincompletereportingofstudyqualitysystematicreviewof9studiesevaluatingSWMEin11,007patientswithdiabetesmellitusanddataonulcerationorlowerextremityamputationinpatientswithnegativeandpositiveSWMEresultsallstudiesreportedtohavequalitylevelof2borhigherusingOxfordCenterforEvidenceBasedMedicinelevelsofevidence,butindividualstudyqualityor

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limitationsnotreporteddiabeticfootulcerationevaluatedin7studieswith10,029patientsfollowedfor14years

followuprangedfrom1to4yearsabsoluteriskofulcerationforpatientswithpositiveSWMErangedfrom12.4%to38.6%absoluteriskofulcerationforpatientswithnegativeSWMErangedfrom2.5%to10.7%relativeriskrangedfrom2.5(95%CI23.2)to7.9(95%CI4.414.3)

lowerextremityamputationsevaluatedin3studieswith1,336patientsfollowedfor1.53.3years

followuprangedfrom1.5to3.3yearsabsoluteriskoflowerextremityamputationforpatientswithpositiveSWMErangedfrom6.4%to35.3%absoluteriskoflowerextremityamputationforpatientswithnegativeSWMErangedfrom1%to21.4%relativeriskrangedfrom1.7(95%CI1.12.6)to15.1(95%CI4.352.6)

ReferenceJVascSurg2011Jan53(1):2204cmof25lbfishingline(homemade10gmonofilament)maybeeffectiveforscreeningfordiabeticneuropathy(level2[midlevel]evidence)

basedondiagnosticcasecontrolstudy579normalcontrolsand292patientswithdiabeticneuropathyevaluateddiagnosticperformanceof4cmof25lbfishingline(equivalentto10gmonofilament)

43%sensitivity99.3%specificity98.7%PPV(assuming55%prevalenceofneuropathy)59%NPV(assuming55%prevalenceofneuropathy)

diagnosticperformanceof8cmof25lbfishingline(equivalentto1gmonofilament)

52%sensitivity96.3%specificity94.6%PPV(assuming55%prevalenceofneuropathy)62%NPV(assuming55%prevalenceofneuropathy)

ReferenceJFamPract2006Jun55(6):505 EBSCOhostFullTextvibrationtestingwithonoffmethodisspecificfordiabeticperipheralneuropathy(level1[likelyreliable]evidence)

basedondiagnosticcohortstudy478patientsindiabetesclinichadblindedevaluationwith4tests

5.07/10gSWME(4timesondorsumofeachgreattoe)superficialpainsensation(4timesoneachfoot)vibrationtestingbyonoffmethod(128Hztuningforktwiceoneachfirsttoe,notingstartandstopofvibration)vibrationtestingbytimedmethod

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nerveconductionstudiesusedasreferencestandardspecificityof5of8testpointsinsensate,positivelikelihoodratio

vibrationtestingbyonoffmethod99%,likelihoodratio26.6vibrationtestingbytimedmethod98%,likelihoodratio18.5SWME96%,likelihoodratio10.2superficialpain97%,likelihoodratio9.2

combinationof2screeningtestsdidnotsignificantlyincreasediagnosticperformanceReferenceDiabetesCare2001Feb24(2):250 EBSCOhostFullTextfulltext

IpswichTouchTestappearstohavehighagreementwithmonofilamenttestforidentifyingriskoffootulcerinpatientswithdiabetes(level2[midlevel]evidence)

basedonindependentderivationandvalidationcohortstudieswithunclearblindinginderivationstudy,265adultswithdiabeteswereassessedwithIpswichTouchTestand10gaugemonofilamenttestIpswichTouchTestinvolveslightandbrief(12seconds)touchingof6sitesofthefeet(tipsofthefirst,third,andfifthtoesofbothfeet)withindexfinger55.5%classifiedasatriskoffootulcerbymonofilamenttest(2insensateareas)vibrationperceptionthresholdof25voltswasusedasadditionalreferencestandardperformanceofIpswichTouchTest(2insensateareas)foridentifyingriskoffootulcer

withmonofilamenttestasreferencestandardsensitivity91.8%specificity96.6%positivepredictivevalue97.1%negativepredictivevalue90.5%

withvibrationperceptionthresholdasreferencestandard,sensitivity75%andspecificity90%

invalidationstudy,331adultswithdiabeteswereassessedwithIpswichTouchTestathomeandinclinic25%ofpatientshad2insensateareasby10gaugemonofilamenttesting(referencestandard)performanceofIpswichTouchTest(2insensateareas)foridentifyingriskoffootulcer

athomesensitivity78.3%specificity93.9%positivepredictivevalue81.2%negativepredictivevalue92.8%

inclinic

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sensitivity81.2%specificity96.4%positivepredictivevalue89.9%negativepredictivevalue96.9%

ReferencesderivationstudyDiabetesCare2011Jul34(7):1517 EBSCOhostFullTextfulltextvalidationstudyDiabetMed2014Sep31(9):1100

neuropathicsensorysymptoms(numbnessofthefeet)arenotsensitivefordetectingpolyneuropathyinpatientswithtype2diabetes(level1[likelyreliable]evidence)

basedondiagnosticcohortstudy588patientswithtype2diabetesin26generalpracticesintheNetherlandshadblindedcomparisonofneuropathicsensorysymptomquestionnaireandneurologicexamscore>4on025scaleonneurologicexamimplieddiagnosisofdiabeticpolyneuropathy,32%patientshaddiabeticpolyneuropathyonexamneuropathicsymptomsassociatedwithdiabeticpolyneuropathywere

numbnessofthefeetsensoryalterationsymptomsofpain

forpatients68yearsold,numbnessoffeethad22%sensitivity,92%specificity,positivelikelihoodratio2.75,andnegativelikelihoodratio0.85ReferenceDiabetMed2000Feb17(2):105 EBSCOhostFullTextinACPJClub2000NovDec133(3):112

7itemMichiganNeuropathyScreeningInstrumentindexmaybespecificbutnotsensitivefordistalsymmetricalperipheralneuropathyinpatientswithtype1diabetes(level2[midlevel]evidence)

basedonderivationcohortstudywithoutvalidation1,184patients(meanage47years)withtype1diabeteswereanalyzedreferencestandardwasexaminationbyneurologistandabnormalnerveconductionfindingsin2anatomicallydistinctnervesamongsural,peroneal,andmediannerves30%ofpatientshaddistalsymmetricalperipheralneuropathyMichiganNeuropathyScreeningInstrument(MNSI)indexderivedfrom19itemMNSIandconsistsof4itemselfadministeredquestionnaireandclinicalexaminationscoredforabnormalfindings(totalscore07points)

questionnaire(yesresponsesscoredas1point)Areyourlegsand/orfeetnumb?Doyoueverhaveanypricklingfeelingsinyourlegsorfeet?Haveyoueverhadanopensoreonyourfoot?Hasyourdoctorevertoldyouthatyouhavediabeticneuropathy?

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PhysicianQualityReportingSystemQualityMeasures:

examination(yesresponsesscoredas1point)Isappearanceof1footabnormal?Areanklereflexesreducedorabsentin1foot?Isvibrationperceptionreducedorabsentin1foot?

diagnosticperformanceofMNSIindexusingcutpoint>2.77fordistalsymmetricalperipheralneuropathy

sensitivity43%specificity95%positivepredictivevalue80%negativepredictivevalue80%

ReferenceDiabetMed2012Jul29(7):937 EBSCOhostFullTextfulltextsomeolderindividualswithoutdiabetesmellitusshouldreceivethesamefootcarescreening,educationandfollowup

basedonstudyof183patientswithdiabetesand125patientswithoutdiabetesreferredtoaFootCareService38%ofpatientswithoutdiabetes>60yearsoldhadperipheralneuropathy(viaSemmesWeinsteinmonofilamenttest)orperipheralvasculardisease(anklebrachialindex

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Guidelines:

Internationalguidelines:

UnitedStatesguidelines:

theroutinescreeninginasymptomaticpatientscouldleadtooveruseofArterialBrachialIndex(ABI)andproceduresforperipheralarterialdiseasethatmaynotbebeneficial.Instead,thereshouldbeafocusonaddressingvascularriskinallpatientswithanemphasisonstatintreatment,bloodpressurecontrolandsmokingcessation."ReferenceACPPerformanceMeasureReview2015Apr27PDF

seePhysicianQualityReportingSystemQualityMeasuresforadditionalinformation

GuidelinesandResources

InternationalWorkingGrouponDiabeticFoot(IWGDF)2011guidelinesonmanagementandpreventionofdiabeticfootcanbefoundinDiabetesMetabResRev2012Feb28Suppl1:225 EBSCOhostFullTextfulltextwoundandwoundbedmanagementcanbefoundinDiabetesMetabResRev2012Feb28Suppl1:232 EBSCOhostFullTextfulltexttreatmentofdiabeticfootinfectionscanbefoundinDiabetesMetabResRev2012Feb28Suppl1:234 EBSCOhostFullTextfulltextdiagnosisandtreatmentofperipheralarterialdiseaseinpatientwithdiabetesandulcerationoffootcanbefoundinDiabetesMetabResRev2012Feb28Suppl1:236 EBSCOhostFullTextfulltext

internationalexpertevidencebasedrecommendationsonnegativepressurewoundtherapy:treatmentvariables(pressurelevels,woundfillerandcontactlayer)canbefoundinJPlastReconstrAesthetSurg2011Sep64Suppl:S1

AmericanCollegeofRadiology(ACR)AppropriatenessCriteriaforsuspectedosteomyelitisoffootinpatientswithdiabetesmellituscanbefoundatACR2012PDForatNationalGuidelineClearinghouse2012Oct22:37915InfectiousDiseasesSocietyofAmerica(IDSA)2012clinicalpracticeguidelineondiagnosisandtreatmentofdiabeticfootinfectionscanbefoundinClinInfectDis2012Jun54(12):e132 EBSCOhostFullTextPDForatNationalGuidelineClearinghouse2012Aug27:37220,executivesummarycanbefoundinClinInfectDis2012Jun54(12):1679 EBSCOhostFullTextPDFAmericanDiabetesAssociation(ADA)

AmericanDiabetesAssociation(ADA)positionstatementonstandardsofmedicalcareindiabetescanbefoundinDiabetesCare2015Jan38Suppl1:S1PDF

summaryofrevisions(DiabetesCare2015Jan38Suppl1:S4 EBSCOhostFullTextfulltext)1.strategiesforimprovingcare(DiabetesCare2015Jan38Suppl1:S5EBSCOhostFullTextfulltext)2.classificationanddiagnosisofdiabetes(DiabetesCare2015Jan38Suppl1:S8 EBSCOhostFullTextfulltext)3.initialevaluationanddiabetesmanagementplanning(DiabetesCare2015Jan38Suppl1:S17 EBSCOhostFullTextfulltext)

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4.foundationsofcare:education,nutrition,physicalactivity,smokingcessation,psychosocialcare,andimmunization(DiabetesCare2015Jan38Suppl1:S20EBSCOhostFullTextfulltext)5.preventionordelayoftype2diabetes(DiabetesCare2015Jan38Suppl1:S31 EBSCOhostFullTextfulltext)6.glycemictargets(DiabetesCare2015Jan38Suppl1:S33 EBSCOhostFullTextfulltext)7.approachestoglycemictreatment(DiabetesCare2015Jan38Suppl1:S41EBSCOhostFullTextfulltext)

8.cardiovasculardiseaseandriskmanagement(DiabetesCare2015Jan38Suppl1:S49 EBSCOhostFullTextfulltext)9.microvascularcomplicationsandfootcare(DiabetesCare2015Jan38Suppl1:S58 EBSCOhostFullTextfulltext)10.olderadults(DiabetesCare2015Jan38Suppl1:S67 EBSCOhostFullTextfulltext)11.childrenandadolescents(DiabetesCare2015Jan38Suppl1:S70EBSCOhostFullTextfulltext)12.managementofdiabetesinpregnancy(DiabetesCare2015Jan38Suppl1:S77 EBSCOhostFullTextfulltext)13.diabetescareinthehospital,nursinghome,andskillednursingfacility(DiabetesCare2015Jan38Suppl1:S80 EBSCOhostFullTextfulltext)14.diabetesadvocacy(DiabetesCare2015Jan38Suppl1:S86 EBSCOhostFullTextfulltext)

ADApolicystatementonpreventivefootcareindiabetescanbefoundinDiabetesCare2004Jan27Suppl1:S63 EBSCOhostFullTextfulltext

WisconsinDiabetesPreventionandControlProgram2012guidelineondiabetesmellitusessentialcareguidelinescanbefoundatWisconsinDepartmentofHealthServices2012MayPDFConvaTecSOLUTIONSwoundcarealgorithmcanbefoundatNationalGuidelineClearinghouse2014Jun30:47857Wound,Ostomy,andContinenceNursesSociety(WOCN)guidelineonmanagementofwoundsinpatientswithlowerextremityneuropathicdiseasecanbefoundatNationalGuidelineClearinghouse2012Nov12:38248,executivesummarycanbefoundinJWoundOstomyContinenceNurs2013JanFeb40(1):34WoundHealingSociety(WHS)guidelineontreatmentofdiabeticulcerscanbefoundinWoundRepairRegen2006NovDec14(6):680 EBSCOhostFullTextAmericanCollegeofFootandAnkleSurgeons(ACFAS)clinicalpracticeguidelineondiabeticfootdisorderscanbefoundinJFootAnkleSurg2006SepOct45(5Suppl):S1expertconsensusrecommendationsonadvancingstandardofcarefortreatingneuropathicfootulcersinpatientswithdiabetescanbefoundinOstomyWoundManage2010Apr56(4Suppl):S1NationalPressureUlcerAdvisoryPanel(NPUAP)guidelineonroleofnutritioninpressureulcerpreventionandtreatmentcanbefoundinAdvSkinWoundCare2009May22(5):212

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UnitedKingdomguidelines:

Canadianguidelines:

Europeanguidelines:

AustralianandNewZealandguidelines:

Reviewarticles:

AmericanSocietyofPlasticSurgeons(ASPS)guidelineonchronicwoundsoflowerextremitycanbefoundatASPSPDFConvaTecSOLUTIONSwoundcarealgorithmcanbefoundatNationalGuidelineClearinghouse2010Mar29:13559expertconsensusstatementonuseoftranscutaneousoximetryindiagnosisofperiwoundoxygentensionandassociationwithwoundhealingcanbefoundinUnderseaHyperbMed2009JanFeb36(1):43

NationalInstituteforHealthandClinicalExcellence(NICE)guidelineonpreventionandmanagementoffootproblemsintype2diabetescanbefoundatNICE2004Jan:CG10PDFNICEguidelineondiabeticfootproblemsinpatientmanagementcanbefoundatNICE2011Mar:CG119PDForatNationalGuidelineClearinghouse2012Apr23:34831,summarycanbefoundinBMJ2011Mar23342:d1280 EBSCOhostFullText

CanadianDiabetesAssociation(CDA)2008guidelineondiabetesmellituscanbefoundatCDA2008PDFRegisteredNursesAssociationofOntario(RNAO)guidelineonassessmentandmanagementoffootulcersforpeoplewithdiabetescanbefoundatRNAO2013MarPDForatNationalGuidelineClearinghouse2014May26:47566RNAOguidelineonreducingfootcomplicationsforpeoplewithdiabetescanbefoundatRNAO2004MarPDF

SpanishSocietyofFamilyandCommunityMedicine/SpanishSocietyofAngiologyandVascularSurgery(SociedadEspaoladeMedicinadeFamiliayComunitaria/SociedadEspaoladeAngiologayCirugaVascular[SEMFYC/SEACV])consensusdocumentoncriteriaforreferralbetweenlevelsofcareofpatientswithperipheralvasculardiseasecanbefoundinAtenPrimaria2012Sep44(9):556[Spanish]

AustralianDiabetesFootNetwork(ADFN)guidelineonmanagementofdiabetesrelatedfootulcerationcanbefoundinMedJAust2012Aug20197(4):226fulltextGeorgeInstituteforGlobalHealth/BakerIDIHeartandDiabetesInstitute/AdelaideHealthTechnologyAssessmentevidencebasedguidelineonprevention,identificationandmanagementoffootcomplicationsindiabetescanbefoundatNHMRC2011AprPDF

reviewsofdiabeticfootulcercanbefoundinBMJ2009Dec2339:b4905 EBSCOhostFullTextBMJ2006Feb18332(7538):407 EBSCOhostFullTextfulltextNEnglJMed2004Jul1351(1):48,commentarycanbefoundinNEnglJMed2004Oct14351(16):1694AmFamPhysician2002Nov166(9):1655 EBSCOhostFullTextfulltext,commentarycanbefoundinAmFamPhysician2003Dec1568(12):2327

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EBSCOhostFullTextfulltextLancet2003May3361(9368):1545 EBSCOhostFullText,commentarycanbefoundinLancet2003Nov29362(9398):1858 EBSCOhostFullTextJFamPract2005Sep54(9):768 EBSCOhostFullTextreviewoftreatmentcanbefoundinLancet2005Nov12366(9498):1725EBSCOhostFullTextreviewoffootulcersandamputationsindiabetescanbefoundinAmFamPhysician2009Oct1580(8):789fulltext

reviewofdiabeticfootcanbefoundinBMJ2003May3326(7396):977 EBSCOhostFullTextfulltextreviewofdiabeticfootinfectionscanbefoundinAmFamPhysician2013Aug188(3):177 EBSCOhostFullTextreviewofdiabeticfootinfectioncanbefoundinAmFamPhysician2008Jul178(1):71 EBSCOhostFullTextfulltextCanadianAgencyforDrugsandTechnologiesinHealth(CADTH)TechnologyOverviewonfootcareforpatientswithperipheralvasculardiseasecanbefoundatCADTH2010SepPDFeditorialreviewofchronicwoundcarecanbefoundinLancet2008Nov29372(9653):1860comprehensiveliteraturereviewofpreventionoffootulcersinpatientswithdiabetescanbefoundinJAMA2005Jan12293(2):217 EBSCOhostFullTextreviewseriescanbefoundinsupplementtoJFamPract2000Nov

reviewofscopeofproblemwithdiabeticfootcanbefoundinJFamPract2000Nov49(11Suppl):S3 EBSCOhostFullTextreviewoffootassessmentinpatientswithdiabetescanbefoundinJFamPract2000Nov49(11Suppl):S9 EBSCOhostFullText,commentarycanbefoundinJFamPract2001Apr50(4):373 EBSCOhostFullTextreviewofpreventionoffootproblemsinpatientswithdiabetescanbefoundinJFamPract2000Nov49(11Suppl):S30 EBSCOhostFullTextreviewofeffectivetreatmentstrategiescanbefoundinJFamPract2000Nov49(11Suppl):S40 EBSCOhostFullText

reviewoffootulcerscanbefoundinNEnglJMed2000Sep14343(11):787,commentarycanbefoundinNEnglJMed2001Jan11344(2):139AmericanDiabetesAssociationliteraturereviewonpreventivefootcarecanbefoundinDiabetesCare1998Dec21(12):2161reviewofapplicationofautologousderivedplateletrichplasmagelintreatmentofchronicwoundulcer:diabeticfootulcercanbefoundinJExtraCorporTechnol2010Mar42(1):20reviewofplateletrichplasmauseinwoundhealingcanbefoundinYaleJBiolMed2010Mar83(1):1fulltextreviewofuseofplateletgrowthfactorsintreatingwoundsandsofttissueinjuriescanbefoundinActaDermatovenerolAlpPanonicaAdriat2007Dec16(4):156PDFreviewofemergingevidenceforappropriateuseofwoundcaretechnologiesinlongtermcarecanbefoundinAnnalsofLongTermCare2007Nov15(11):35

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MEDLINEsearch:

ICD9codes:

ICD10codes:

Generalreferencesused:

reviewofprinciplesofcastingandsplintingcanbefoundinAmFamPhysician2009Jan179(1):16 EBSCOhostFullTextfulltext

tosearchMEDLINEfor(Diabeticfootulcer)withtargetedsearch(ClinicalQueries),clicktherapy,diagnosis,orprognosis

PatientInformation

handoutcanbefoundinAmFamPhysician1998Mar1557(6):1325fulltexthandoutcanbefoundinJAMA2005Jan12293(2):260fulltexthandoutfromPatientUKPDFhandoutfromMountSinaiHospitaltechnicalinformationondiabeticfootfromPatientPlusPDFhandoutondiabeticwoundcarefromAmericanPodiatricMedicalAssociationhandoutonprotectingyourfeetfromamputationanddiabetesfromMayoClinichandoutontotalcontactcastfromAmericanAcademyofFamilyPhysiciansorinSpanishhandoutonfootproblemswithdiabetesfromClevelandClinic

ICD9/ICD10Codes

686.8otherspecifiedlocalinfectionsofskinandsubcutaneoustissue686.9unspecifiedlocalinfectionsofskinandsubcutaneoustissue707.1ulceroflowerlimbs,exceptpressureulcer

707.10unspecifiedulceroflowerlimb707.11ulcerofthigh707.12ulcerofcalf707.13ulcerofankle707.14ulcerofheelandmidfoot707.15ulcerofotherpartoffoot707.19ulcerofotherpartoflowerlimb

707.8chroniculcerofotherspecifiedsites707.9chroniculcerofunspecifiedsite

E10.5insulindependentdiabetesmellituswithperipheralcirculatorycomplicationsE11.5noninsulindependentdiabetesmellituswithperipheralcirculatorycomplicationsE12.5malnutritionrelateddiabetesmellituswithperipheralcirculatorycomplicationsE13.5otherspecifieddiabetesmellituswithperipheralcirculatorycomplicationsE14.5unspecifieddiabetesmellituswithperipheralcirculatorycomplicationsL08.8otherspecifiedlocalinfectionsofskinandsubcutaneoustissueL97ulceroflowerlimb,notelsewhereclassifiedL98.4chroniculcerofskin,notelsewhereclassified

References

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Recommendationgradingsystemsused:

1.LipskyBA,BerendtAR,CorniaPB,etal.2012InfectiousDiseasesSocietyofAmericaclinicalpracticeguidelineforthediagnosisandtreatmentofdiabeticfootinfections.ClinInfectDis.2012Jun54(12):e13273 EBSCOhostFullTextPDF,executivesummarycanbefoundinClinInfectDis2012Jun54(12):1679EBSCOhostFullTextPDF2.SteedDL,AttingerC,ColaizziT,etal.Guidelinesforthetreatmentofdiabeticulcers.WoundRepairRegen.2006NovDec14(6):68092. EBSCOhostFullText

InfectiousDiseasesSocietyofAmerica(IDSA)gradesofrecommendationstrengthofrecommendation

Strongrecommendationdesirableeffectsclearlyoutweighundesirableeffects,orviceversaWeakrecommendationdesirableeffectscloselybalancedwithundesirableeffects,or(withLoworVerylowqualityevidence)uncertaintyinestimatesofdesirableeffects,harms,andburdensotheymaybecloselybalanced

qualityofevidenceHighqualityevidenceconsistentevidencefromwellperformedrandomizedcontrolledtrials(RCTs)orexceptionallystrongevidencefromunbiasedobservationalstudiesModeratequalityevidenceevidencefromRCTswithimportantlimitations(inconsistentresults,methodologicflaws,indirect,orimprecise)orexceptionallystrongevidencefromunbiasedobservationalstudiesLowqualityevidenceevidencefor1criticaloutcomefromobservationalstudies,RCTswithseriousflaws,orindirectevidenceVerylowqualityevidenceevidencefor1criticaloutcomefromunsystematicclinicalobservationsorveryindirectevidence

ReferenceIDSA2012clinicalpracticeguidelineondiagnosisandtreatmentofdiabeticfootinfections(ClinInfectDis2012Jun54(12):e132 EBSCOhostFullText)PDF

AmericanDiabetesAssociation(ADA)evidencegradingsystemforclinicalpracticerecommendations

GradeAclearevidencefromwellconducted,generalizable,randomizedcontrolledtrials(RCTs)thatareadequatelypowered,includingevidencefromwellconductedmulticentertrialormetaanalysisthatincorporatedqualityratingsinanalysiscompellingnonexperimentalevidence,specifically,"allornone"ruledevelopedbyCenterforEvidenceBasedMedicineatOxfordsupportiveevidencefromwellconductedRCTsthatareadequatelypowered,includingevidencefromwellconductedtrialat1institutionormetaanalysisthatincorporatedqualityratingsinanalysis

GradeBsupportiveevidencefromwellconductedcohortstudies,includingevidencefromwellconductedprospectivecohortstudyorregistryormetaanalysisofcohort

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GradeCsupportiveevidencefrompoorlycontrolledoruncontrolledstudies

evidencefromrandomizedclinicaltrialswith1majoror3minormethodologicflawsthatcouldinvalidateresultsevidencefromobservationalstudieswithhighpotentialforbias(suchascaseserieswithcomparisontohistoricalcontrols)evidencefromcaseseriesorcasereports

conflictingevidencewithweightofevidencesupportingrecommendationGradeEexpertconsensusorclinicalexperienceReferenceADA2015positionstatementonstandardsofmedicalcareindiabetes:introduction(DiabetesCare2015Jan38Suppl1:S1 EBSCOhostFullTextfulltext)

DynaMedtopicsarecreatedandmaintainedbytheDynaMedEditorialTeam.Over500journalsandevidencebasedsources(DynaMedContentSources)aremonitoreddirectlyorindirectlyusinga7Stepevidencebasedmethodforsystematicliteraturesurveillance.DynaMedtopicsareupdateddailyasnewlydiscoveredbestavailableevidenceisidentified.TheparticipatingmembersoftheDynaMedEditorialTeamhavedeclaredthattheyhavenofinancialorothercompetinginterestsrelatedtothistopic.Theparticipatingreviewershavedeclaredthattheyhavenofinancialorothercompetinginterestsrelatedtothistopic,unlessotherwiseindicated.McMasterUniversityisapartnerthatprovidessupportinidentifyingPracticeChangingDynaMedUpdates.Over1,000practicingphysiciansfrom61disciplinesin77countriesratethesearticlestohelpyoufindthemostusefulnewevidenceaffectingyourpractice.F1000isapartnerthatprovidessupportinidentifyingPracticeChangingDynaMedUpdates.Over2,000practicingcliniciansfrom20disciplinesin60countriesratethesearticlestohelpyoufindthemostusefulnewevidenceaffectingyourpractice.

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