Study Comparing E-GRAFT12 Amnion Membrane Allograft Versus Standard Care Dressing FIBRACOL12 in Treating Venous Leg Ulcers

What this Trial Is About

This research investigates the treatment of Venous Leg Ulcers (VLUs) by comparing two types of wound dressings combined with standard care. The study evaluates whether using E-GRAFT12, a dehydrated thick amniotic allograft approved as a Human Cellular and Tissue-Based Product, leads to better wound closure compared to FIBRACOL12, a collagen alginate dressing cleared by the FDA. The main goal is to see which treatment results in a higher proportion of healed ulcers over 12 weeks, along with assessments of wound size changes, pain levels, infection occurrence, and any side effects. Participants will be randomly assigned to receive either E-GRAFT12 or FIBRACOL12 as the primary dressing along with standard of care. The target ulcer must be on the foot or leg and meet specific size and duration criteria. Both treatment groups will follow standard off-loading methods and compression therapy. The study includes weekly visits during which dressings are applied and wound progress is monitored. Throughout the 12-week treatment period, participants will attend weekly study visits to assess wound healing, measure ulcer size, and monitor for infections or adverse events. Pain levels and any reactions to treatments will also be recorded. The primary outcome is the proportion of ulcers completely closed at 12 weeks. Participants must commit to regular visits and prescribed off-loading to support healing and accurate study assessments.

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