Evaluating Amnio-Maxx Dual Layer Amnion Patch with Standard Care for Healing Chronic Diabetic Foot Ulcers

What this Trial Is About

Researchers are evaluating the use of a cellular, acellular, matrix-like product called Amnio-Maxx4 Dual Layer Amnion Patch alongside the Standard of Care SOC compared to SOC alone for closing nonhealing diabetic foot ulcers DFUs. This Phase 4 randomized controlled trial focuses on adult patients with chronic DFUs to better understand how Amnio-Maxx may affect healing rates. Participants will receive either the Standard of Care, which includes cleansing, debridement, wound documentation, and off-loading, or the Standard of Care plus the application of the Amnio-Maxx Dual Layer Amnion Patch. The study uses random assignment without masking. Treatments are applied during study visits, and the ulcer is carefully monitored for closure and healing progress. During the 12-week trial, participants will undergo assessments including ulcer measurements to evaluate complete closure and percentage area reduction. Pain related to the ulcer will be tracked using the Numeric Pain Rating Scale. Researchers will also monitor adverse events throughout the study. Participants must follow treatment protocols and attend regular visits to support accurate evaluation of outcomes related to healing diabetic foot ulcers.

Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.