A multicenter, randomized, controlled clinical trial evaluating the use of dehydrated human amnion/chorion membrane allografts and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers
Open Access
- 1 November 2014
- journal article
- research article
- Published by Wiley in Wound Repair and Regeneration
- Vol. 22 (6), 688-693
- https://doi.org/10.1111/wrr.12227
Abstract
Venous leg ulcers produce significant clinical and economic burdens on society and often require advanced wound therapy. The purpose of this multicenter, randomized, controlled study is to evaluate the safety and efficacy of one or two applications of dehydrated human amnion/chorion membrane allograft and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers. The primary study outcome was the proportion of patients achieving 40% wound closure at 4 weeks. Of the 84 participants enrolled, 53 were randomized to receive allograft and 31 were randomized to the control group of multilayer compression therapy alone. At 4 weeks, 62% in the allograft group and 32% in the control group showed a greater than 40% wound closure (p = 0.005), thus showing a significant difference between the allograft-treated groups and the multilayer compression therapy alone group at the 4-week surrogate endpoint. After 4 weeks, wounds treated with allograft had reduced in size a mean of 48.1% compared with 19.0% for controls. Venous leg ulcers treated with allograft had a significant improvement in healing at 4 weeks compared with multilayer compression therapy alone.Keywords
Funding Information
- MiMedx Group, Inc.
This publication has 14 references indexed in Scilit:
- Comparative effectiveness of a bilayered living cellular construct and a porcine collagen wound dressing in the treatment of venous leg ulcersWound Repair and Regeneration, 2014
- A prospective, randomised comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcersInternational Wound Journal, 2014
- Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healingInternational Wound Journal, 2013
- An evaluation of dehydrated human amniotic membrane allografts in patients with DFUsJournal of Wound Care, 2013
- A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcersInternational Wound Journal, 2013
- Chronic Venous Insufficiency and Varicose VeinsNew England Journal of Medicine, 2009
- Antibiotics and antiseptics for venous leg ulcersPublished by Wiley ,2007
- The accuracy of venous leg ulcer prognostic models in a wound care systemWound Repair and Regeneration, 2004
- Surrogate Endpoints for the Treatment of Venous Leg UlcersJournal of Investigative Dermatology, 2002
- Venous leg ulcer: Incidence and prevalence in the elderlyJournal of the American Academy of Dermatology, 2002