Testing placental membrane patches for hard-to-heal diabetic foot wounds

Plain-English translation of NCT06449638 on ClinicalTrials.gov ↗ · Source last updated March 2026 · Translation generated July 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?

The CAMPSTIM trial is testing four different types of human placental membrane patches—called Revita, Relese, Cogenex, and Enverse—to see if they can help heal diabetic foot ulcers that haven't improved with standard wound care. You would receive one of these patches applied to your wound, along with regular wound care and offloading (keeping pressure off the area). The researchers want to find out which approach works best.

Some diabetic foot ulcers are very hard to heal even with careful wound care, and people with these wounds face serious complications. This trial is looking for new ways to speed up healing and prevent the need for amputation.

Do you qualify?

You likely qualify if…

you are 18 years of age or older
you have been diagnosed with type 1 or type 2 diabetes
you have a diabetic foot ulcer that has been present for at least 4 weeks but no more than 1 year
your ulcer is between 1 and 25 square centimeters in size (about the size of a postage stamp to a large coin) after cleaning
your foot has adequate blood flow, confirmed by a recent vascular test
you are willing to attend weekly study visits and use the prescribed offloading method (special shoe or device to reduce pressure)

You likely don't qualify if…

you have an active infection in or around the ulcer, or cellulitis (skin infection)
your ulcer exposes bone or tendon
you have osteomyelitis (bone infection) in the affected foot
you are currently taking medications that suppress your immune system (like high-dose steroids) or certain other drugs that interfere with wound healing
your diabetes is very poorly controlled, with a hemoglobin A1c of 12% or higher

What participation looks like

If you join this trial, you will be randomly assigned to receive either standard wound care alone, or standard wound care plus one of the four placental membrane patches. Standard care includes regular wound cleaning, removal of dead tissue, moisture balance, and offloading your foot. You will need to attend weekly visits for the research team to check your wound's progress using a special imaging device. The study will track how well your wound heals over time.

AI-generated summary from trial data · Jul 16, 2026 · Not medical advice

Trial locations(5 sites)

United States

SerenaGroup Omaha Research Center, Omaha, Nebraska

Wound Care of Tulsa, Tulsa, Oklahoma

SerenaGroup Research South, Jefferson Hills, Pennsylvania

Armstrong County Memorial Hospital, Kittanning, Pennsylvania

SerenaGroup Monroeville, Monroeville, Pennsylvania