This study is looking into whether a product called FoundationDRS Solo can help heal diabetic foot ulcers that haven't responded to standard treatments. FoundationDRS Solo is a special material made from chitosan and chondroitin sulfate, designed to support wound healing. You might be able to join if you are at least 18 years old, have type 1 or 2 diabetes, and have a non-healing foot ulcer between 1.0 and 20 square centimeters. The study will compare healing rates after 12 weeks in people who receive FoundationDRS Solo plus standard care versus those who receive standard care alone. The goal is to see if adding FoundationDRS Solo leads to more complete wound closures.

Study design

This interventional study plans to enroll 124 participants. One ulcer on each participant will be randomly assigned to receive either FoundationDRS Solo with standard care or standard care alone.

What's involved

One ulcer on your foot will receive weekly applications of either FoundationDRS Solo and standard care or standard care alone for 12 weeks.

Compensation

Not stated in the trial record.

Follow-up

The primary outcome of complete wound closure is measured at 12 weeks after the study screening phase.

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