Study Comparing Dehydrated Human Placental Tissue and Standard Care to Standard Care Alone for Healing Diabetic Foot Ulcers

What this Trial Is About

Diabetic foot ulcers DFUs are a common and serious complication for people with diabetes, often challenging to heal with standard treatments. This research evaluates how well a new product, Amnion-Intermediate-Chorion AIC, made from dehydrated human placental tissue, works alongside standard care compared to standard care alone in closing these ulcers. The trial is a Phase 4, randomized study focused on improving healing outcomes for diabetic foot ulcers. Participants will receive standard care, which includes cleaning, removing damaged tissue, managing moisture, and offloading pressure from the ulcer. One group will receive only this standard care weekly for up to 12 weeks or until the ulcer closes. The other group will receive the same standard care plus weekly application of the AIC sheet product during the same period. This treatment phase begins after a screening visit and continues based on ulcer healing or treatment duration limits. During the study, participants will attend regular visits to assess ulcer healing, pain changes, wound size, and any side effects. Researchers will measure how many ulcers fully close within 1 to 12 weeks and track the time it takes to heal. Quality of life changes will also be evaluated. The study includes monitoring safety and effectiveness through these assessments, with participants involved for up to 12 weeks of treatment.

Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)