Study Comparing E-GRAFT12 Amnion Membrane Allograft and FIBRACOL12 Collagen Alginate Dressing with Standard Care for Treating Non-Healing Venous Leg Ulcers

What this Trial Is About

This research aims to compare wound healing in patients with venous leg ulcers VLUs treated with two different dressing methods. It evaluates the percentage of wound closure when using E-GRAFT, a dehydrated thick amniotic allograft, plus standard care SOC versus FIBRACOL, a collagen alginate dressing plus SOC. The study also examines the rate of wound closure, changes in ulcer size over 12 weeks, pain levels, infection occurrence, and any side effects. Participants are randomly assigned to one of two groups one group receives standard care with E-GRAFT as the primary dressing, while the other receives standard care with FIBRACOL as the primary dressing. Both dressings are used on venous leg ulcers that meet specific size and duration criteria. The study involves weekly visits and treatment over a 12-week period, during which the healing progress and safety are closely monitored. During the study, participants attend weekly visits for wound assessment and treatment. Researchers measure wound closure rates, time to healing, and changes in ulcer size. They also track pain, any infections, and adverse events. The primary outcome is the proportion of ulcers healed by 12 weeks. Participants must agree to use prescribed off-loading methods and compression therapy. The total participation duration is about 12 weeks, during which safety and healing are carefully observed.

Clinical Trial Evaluating an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Venous Leg Ulcers Versus Standard Of Care Alone