Study Comparing E-GRAFT12 Amnion Membrane Allograft With Standard Care Dressings for Healing Diabetic Foot Ulcers

What this Trial Is About

Researchers are evaluating two treatments for diabetic foot ulcers DFUs to see which is more effective in helping wounds heal. This study compares wound healing rates between patients treated with E-GRAFT, a dehydrated amniotic membrane allograft, and those treated with FIBRACOL, a collagen alginate dressing, both combined with standard care. The study aims to measure wound closure rates, ulcer size changes, nerve damage, pain levels, and infections over 12 weeks. Participants are randomly assigned to receive either E-GRAFT or FIBRACOL as their primary dressing along with standard care. The E-GRAFT is a human tissue product approved by the FDA, while FIBRACOL is a cleared collagen-based dressing. Both treatments are applied over a 12-week period. Patients must follow offloading methods for ulcers on the plantar foot and attend weekly visits throughout the study. During the trial, participants will have weekly visits to monitor wound healing, pain, nerve function, and any side effects or infections. Measurements include the proportion of ulcers completely healed at 12 weeks and the time taken for healing. Researchers will also track changes in ulcer size and neuropathy. The study lasts for at least 12 weeks, with detailed assessments to understand each treatments impact on wound healing and related factors.

Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care