Study Comparing Dehydrated Human Amnion Membrane Plus Standard Care to Standard Care Alone for Healing Nonhealing Diabetic Foot Ulcers

What this Trial Is About

Researchers are evaluating the effectiveness of dehydrated human amnion membrane dhAM combined with standard care compared to standard care alone in healing nonhealing diabetic foot ulcers DFUs. This multi-center randomized controlled trial aims to determine if adding dhAM helps close these ulcers more efficiently in people with diabetes. The study is sponsored by Axolotl Biologix and focuses on patients with specific ulcer characteristics and diabetes types 1 or 2. Participants will be randomly assigned to one of two groups one receiving standard care alone, which includes cleaning, debridement, moisture balance, and offloading, and the other receiving weekly applications of Axolotl DualGraft dhAM plus standard care. Treatments will continue weekly until the ulcer closes or for a maximum of 12 weeks. The study will compare healing outcomes between these two approaches. During the study, participants will attend weekly visits for treatment and monitoring. Researchers will assess ulcer closure, time to healing, changes in ulcer size, and any adverse events over 1 to 12 weeks. Quality of life related to the wound will also be evaluated using questionnaires. The overall goal is to understand how the addition of dhAM affects healing and patient experience over the study period ending in October 2025.

Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers