This study is testing a treatment called Amnio-Maxx® Dual Layer Amnion Patch for chronic diabetic foot ulcers (DFUs), which are sores on the feet that don't heal well in people with diabetes. The study will compare how well Amnio-Maxx, along with standard care (like wound cleaning and special footwear), helps ulcers heal compared to standard care alone. We want to see if Amnio-Maxx can help these ulcers close completely or reduce their size over 12 weeks. You may be able to join if you are 18 or older, have Type I or Type II diabetes, and have a non-healing diabetic foot ulcer. The current status of this study is unclear, and it plans to enroll 248 people.

Study design

This study is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 248 participants.

What's involved

Not specified in the trial record.

Compensation

Not stated in the trial record.

Follow-up

The primary outcomes, complete ulcer closure and expected percentage area reduction, are measured at 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.