A  Mul&-­‐center  Randomized  Controlled  Clinical  Trial  of  Dehydrated  Human  Amnion/Chorion  Membrane  and  Standard  of  Care  vs.  Standard  of  Care  Alone  in  

the  Treatment  of  Venous  Leg  Ulcers

Thomas  Serena  MD,  Don  FeGerolf  MD,  Stan  Harris,  Bryan  Doner  DO,  Keyur  Patel  DO,  MaGhew  Sabo  DPM,  Daniel  DeMarco  DO,  Eric  Lullove  DPM,  Lam  Le  MD,  Chris&ne  SheGel  RN,  Sharon  McConnell  CCRC,  Heather  Connell  CCRP  

Introduction

Methods

Conclusions

Acknowledgements Reference

s

Venous   leg   ulcers   pose   significant   clinical,   humanis4c  and   economic   burdens   on   society.   Standard   of   care,  mul4-­‐layer   compression   therapy   (MCT),   results   in  healing   of   only   50%   of   venous   leg   ulcers   in   12   weeks.  Dehydrated   human   amnion/chorion   membrane*  (dHACM)   promotes   healing   by   replacing   damaged  extracellular   matrix   and   providing   cytokine   growth  factors.      This  randomized  controlled  clinical  trial  was  designed  to  evaluate   the   efficacy   of   dHACM   in   the   treatment   of  venous   leg   ulcers.   A   surrogate   endpoint   of   percentage  reduc4on  in  surface  area  at  4  weeks  was  employed.    

A   mul4-­‐center,   randomized,   controlled   open-­‐label  clinical  trial  evalua4ng  the  safety  and  efficacy  of  dHACM  (1   applica4on   or   2   applica4ons   two   weeks   apart)   plus  MCT   versus   MCT   alone   (Coban™2,   3M™)   in   the  treatment   of   venous   leg   ulcers  was   conducted   at   eight  geographically  dis4nct  sites  in  the  United  States.      The  trial  u4lized  a  surrogate  endpoint  which  is  known  to  be   a   predictor   of   healing   at   12   weeks:   The   primary  outcome  measure  was  the  propor4on  of  ulcers  achieving  40%  wound  closure  at  4  weeks  comparing  MCT  alone  to  one  or  two  applica4ons  of  dHACM.    

90   par4cipants   have   been   enrolled   to   date   in   this  ongoing  trial.  68  have  completed  the  study:  44  ulcers  were   randomized   to   receive   dHACM   (1   or   2  applica4ons)  and  24  received  MCT  alone.        Outcomes   were   similar   within   the   dHACM   group.  Comparisons   between   combined   dHACM   groups  versus  MCT  group  presented  in  figures.

Results

Dehydrated  human  amnion/chorion  membrane  resulted  in  more  rapid  healing  of  venous  leg  ulcers  compared  to  standard  of  care  at  the  surrogate  endpoint  of  percentage  of  wound  area  reduc4on  at  four  weeks.  

This  trial  was  supported  by  an  unrestricted  grant  from  MiMedx®.    *EpiFix®  -­‐  MiMedx  Group  Inc.,  Marie_a,  GA      EpiFix®,  PURION®  and  MiMedx®  are  registered  trademarks  of  MiMedx  Group,  Inc.  Coban™2  is  a  registered  trademark  of  3M™.  

1.  Zelen  C,  Serena  TE,  Denoziere  G,  Fe_erolf  DE.  A  prospec4ve  randomized  compara4ve  parallel  study  of  amnio4c  membrane  wound  graa  on  the  management  of  diabe4c  foot  ulcers.  Int  Wound  J  2013.  DOI    10.1111/iwj.12097.    

63.6%  

25.0%  

0.0%  

10.0%  

20.0%  

30.0%  

40.0%  

50.0%  

60.0%  

70.0%  

dHACM/MCT   MCT  only  

>/=40%  Reduc&on  in  VLU  Size  at  4  Weeks  

p=0.0023  

dHACM/MCT   MCT  only  VLU  size  at  

randomiza4on   5.7   7  

VLU  size  aaer  4  weeks  of  treatment  

3.5   6.9  

5.7  

7  

3.5  

6.9  

0  1  2  3  4  5  6  7  8  

VLU  size  (cm  sq

uared)  

VLU  Size  at  Randomiza&on  vs.  Week  4  

p=0.036  

p=0.299  

Case  example.  #1:  1  dHACM  applica&on.    Wound  reduced  84%  at  4  weeks  .-­‐5.5  cm2  to  0.9  cm2  

Case  example.  #2:  2  dHACM  applica&ons.    Wound  reduced  90.5%  at  4  weeks  -­‐2.1cm2  to  0.2  cm2  

Baseline   4  weeks  

Baseline  Baseline  4  weeks  

EP249.001