Collagen skin substitute versus fish skin for diabetic foot wounds

Plain-English translation of NCT07781917 on ClinicalTrials.gov ↗ · Source last updated September 2026 · Translation generated October 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 two different skin substitute materials to treat diabetic foot ulcers—persistent wounds that don't heal well on their own. One option is a high-purity type-I collagen-based skin substitute, and the other is an acellular intact fish-skin matrix. Both will be used alongside standard wound care, and researchers want to see which one helps ulcers close completely by week 12.

Diabetic foot ulcers are a serious complication of diabetes that can lead to infection and amputation if not treated effectively. This trial exists to find the most effective skin substitute material to help these stubborn wounds heal and improve patients' outcomes.

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
your diabetic foot ulcer has been present for at least 4 weeks and has not improved by 30% or more on its own
you have adequate blood circulation to your affected foot (measured by ankle-brachial index between 0.7 and 1.3)
your diabetes control is reasonably stable (HbA1c of 12% or less)
you are able and willing to attend all scheduled study visits and use prescribed off-loading methods (special footwear or techniques to reduce pressure on the ulcer)

You likely don't qualify if…

you have an active infection in your target ulcer or surrounding skin requiring antibiotics
your ulcer has exposed bone, or you have been diagnosed with osteomyelitis (bone infection)
you are currently taking immunosuppressant medications or high-dose steroids (more than 10 mg prednisone daily)
you have end-stage kidney disease requiring dialysis, or you have an active cancer diagnosis
you are pregnant or planning to become pregnant within the next 6 months, or you have a known allergy to fish or collagen-based products

What participation looks like

If you qualify, you will be randomly assigned to receive either the collagen-based skin substitute or the fish-skin matrix treatment. Both groups will receive the same standard wound care with layered dressings applied after treatment. You will visit the study clinic regularly over 12 weeks, during which the research team will photograph and measure your ulcer to track whether it is healing. The treatment will be applied weekly or as needed, and you will need to consistently use the off-loading method prescribed to reduce pressure on your foot.

AI-generated summary from trial data · Oct 5, 2026 · Not medical advice

Trial locations(4 sites)

Bangladesh

National Institute of Burn & Plastic Surgery, Dhaka

EKAGRA Health, Dhaka

India

Adichunchanagiri Institute of Medical Sciences, Mandya, Karnataka

Mysore Medical College and Research Institute, Mysore, Karnataka