This study is looking into whether adding Orion™ Amniotic Membrane Allograft to standard wound care can help people with diabetic foot ulcers heal better. Orion™ is a sterile (germ-free) allograft (tissue from a donor) made from dehydrated (dried) extracellular matrix, which is designed to help wounds heal by providing a protective covering. Standard wound care involves cleaning the wound, checking for infection, and using dressings and special footwear to take pressure off the foot. You might be able to join if you are between 50 and 85 years old and have a diabetic foot ulcer on your foot. The main goal is to see how many people have their wounds completely close within 12 weeks. The study is currently recruiting 240 participants.

Study design

This is an interventional study comparing two groups: one receiving standard wound care and another receiving standard wound care plus the Orion™ Amniotic Membrane Allograft. It plans to enroll 240 participants.

What's involved

Participants will receive weekly wound care for 12 weeks. This includes surgical debridement (removal of dead tissue) if needed, infection screening, and application of dressings.

Compensation

Not stated in the trial record.

Follow-up

The primary outcome of complete wound closure is measured from the start of the study until the last visit of the 12-week wound management period.

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