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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Asan Medical Center
Seoul, Seoul, 05505, South Korea
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Borame Medical Center
Seoul, Seoul, 07061, South Korea
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Bucheon ST. Mary's Hospital
Gyeonggi-do, Bucheon, 14647, South Korea
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Korea University Guro Hospital
Seoul, Seoul, 08308, South Korea
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Seoul National University Bundang Hospital
Gyeonggi-do, Seongnam-si, 13620, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Tailor-Made felt dressing speed up diabetic wound healing?
- Can a vacuum chamber help heal stubborn leg wounds?
- Could a simple exercise program speed healing of diabetic foot ulcers?
- Could stem cells from the placenta heal stubborn diabetic wounds?
- Smartphone app could let diabetic foot ulcer patients skip clinic visits for wound checks
- Wearable insoles warn of foot pressure to stop diabetic ulcers