A Multicenter Hybrid Platform Trial Comparing Tri-Layer and Single-Layer Amnion Grafts to Matched Controls in Hard-to-Heal Diabetic Foot and Venous Leg Ulcers

What this Trial Is About

Researchers are evaluating the effects of two types of amnion grafts—a tri-layer and a single-layer membrane wrap—on hard-to-heal diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). This multicenter hybrid platform trial compares these interventions to a matched retrospective control group receiving standard care. The study aims to gather real-world evidence to better understand how these treatments perform in everyday clinical settings across a diverse patient population. Participants are randomly assigned to receive either the BioLab Membrane Wrap Lite, a single-layer human amnion graft, or the BioLab Tri-Membrane Wrap, a triple-layer graft containing amnion and chorion layers. Both grafts are used alongside standard care, which includes debridement, moisture balance maintenance, bacterial reduction, offloading, and compression. The control group consists of matched patients from a large wound registry receiving standard care alone. During the study, participants will be monitored for wound healing progress, with the primary outcome being wound closure at 12 weeks. Secondary outcomes include wound area reduction at 4, 8, and 12 weeks. The study involves regular visits to assess wound size and healing status. This research helps evaluate the potential benefits of adding amnion grafts to standard wound care over a 12-week period.

CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations