Testing a new wound treatment for diabetic foot ulcers

Plain-English translation of NCT07116174 on ClinicalTrials.gov ↗ · Source last updated March 2026 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing (XAM), a treatment made from amniotic membrane that is applied directly to diabetic foot ulcers. Researchers want to see if adding this treatment to your regular wound care helps ulcers heal completely within 12 weeks, compared to standard care alone. The study will enroll about 135 people with diabetic foot ulcers that haven't healed with typical treatment.

Diabetic foot ulcers are difficult to heal and can lead to serious complications, including infection or amputation. Doctors are looking for new treatments that, when combined with standard wound care, might help these stubborn ulcers close faster and more reliably.

Do you qualify?

You likely qualify if…

you are 18 years old or older
you have type 1 or type 2 diabetes controlled with insulin or medications
you have a foot ulcer that has not healed for at least 4 weeks but less than 1 year, despite standard treatment
your ulcer is located at or below the ankle, between 1.5 and 20 square centimeters in size, and extends through the skin but not to muscle or bone
you have adequate blood flow to your foot, as confirmed by recent blood vessel testing

You likely don't qualify if…

you have signs of an active infection or are currently taking antibiotics for your ulcer
your ulcer extends down to muscle, tendon, or bone
you have had a leg revascularization procedure less than 12 weeks ago
you are pregnant or planning to become pregnant during the study, or are unwilling to use contraception if applicable

What participation looks like

If you qualify, you will visit the clinic once a week for 12 weeks to receive the treatment applied to your ulcer. You'll continue your regular wound care (dressing changes, off-loading your foot if needed) during this time. After the 12-week treatment period ends, you'll return for one follow-up visit two weeks later so the researchers can see how well your ulcer has healed.

AI-generated summary from trial data · Jun 10, 2026 · Not medical advice

Testing a new wound treatment for diabetic foot ulcers

What is this trial?

Do you qualify?

What participation looks like

Trial locations