Stem cell patch shows promise for diabetic foot wounds

NCT ID NCT04569409

First seen Jun 26, 2026 ยท Last updated Jun 26, 2026

Summary

This Phase 3 study tested a sheet of donated stem cells (ALLO-ASC-DFU) on diabetic foot ulcers that have not healed for weeks. 104 adults with type 1 or type 2 diabetes and Wagner grade 2 ulcers were randomly assigned to receive the stem cell sheet or a placebo sheet. The main goal was to see if the stem cell sheet helped more wounds close completely.

What this could mean

Our plain-language read of the trial. This is informational only โ€” not medical advice or a prediction.

Active substance
ALLO-ASC-DFU (a sheet of donated stem cells applied to the wound)
What this could lead to
If it works, this could provide a new treatment to help diabetic foot ulcers heal faster and more completely, reducing the risk of infection or amputation.
What could go wrong
This is a Phase 3 trial, but with only 104 participants, results may not apply to everyone. The treatment is a sheet applied to the wound, so it may not work for deeper or more complex ulcers.

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Conditions

The condition(s) this trial relates to.

Diabetic Foot

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, Seoul, 05505, South Korea

  • Borame Medical Center

    Seoul, Seoul, 07061, South Korea

  • Bucheon ST. Mary's Hospital

    Gyeonggi-do, Bucheon, 14647, South Korea

  • Korea University Guro Hospital

    Seoul, Seoul, 08308, South Korea

  • Seoul National University Bundang Hospital

    Gyeonggi-do, Seongnam-si, 13620, South Korea

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