This study is looking into whether adding special tissue grafts, called perinatal tissue allografts, can help heal diabetic foot ulcers that haven't closed with standard care. These allografts come in two types: a dual-layer amnion-amnion allograft and a three-layer amnion-chorion-amnion allograft. You could be eligible if you are at least 18 years old, have type 1 or 2 diabetes, and have a foot ulcer between 1.0 cm² and 20.0 cm² in size. The main goal is to see if using these allografts along with standard wound care leads to more ulcers completely closing after 12 weeks compared to standard care alone. The study plans to enroll 170 participants.

Study design

This is an interventional study comparing two types of perinatal tissue allografts plus standard care to standard care alone for diabetic foot ulcers. It aims to enroll 170 participants.

What's involved

One ulcer on your foot will receive weekly applications of either a perinatal tissue allograft and standard wound management, or standard wound management alone.

Compensation

Not stated in the trial record.

Follow-up

The primary endpoint for measuring complete wound closure is 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.