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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