Skin Graft Trial Results to Be Shared in October
Results from a phase 3 study on diabetic foot ulcer treatment will be presented to medical experts.
Updated on Sept. 29, 2026 in Diabetes
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The Symposium on Advanced Wound Care will host a presentation on October 16, 2026, featuring results from the COVER DFUS II clinical trial. This study investigates the efficacy of the regenerative product SkinTE in treating diabetic foot ulcers.
Why it matters
Diabetic foot ulcers remain a significant clinical challenge that can lead to severe complications. By focusing on non-healing wounds, this trial aims to provide data on whether this regenerative therapy can improve closure rates for patients with advanced pathology.
The COVER DFUS II trial enrolled 120 patients across the United States to compare the regenerative product SkinTE against standard care. Researchers measured the incidence of complete wound closure within 12 weeks for patients whose ulcers did not respond significantly during a run-in period.
The players
Robert S. Kirsner
He serves as the Study Chair for the COVER DFUS II clinical trial.
PolarityBio
The biotechnology firm is developing SkinTE for the treatment of complex wounds.
The details
The study focuses on Wagner Grade 1 diabetic foot ulcers, which are notoriously difficult to heal. Participants underwent a two-week run-in period to isolate truly chronic, non-healing wounds, with only those showing less than 30% size reduction qualifying for the 1:1 randomization. SkinTE consists of autologous cutaneous multicellular units, a regenerative approach designed to promote tissue repair in persistent wounds.
Timeline
October 16, 2026, is the date for the trial result presentation.
March 16, 2027, is the target date for the FDA decision on the therapy.
Health Landscape
This development marks a key milestone for regenerative therapies currently undergoing evaluation via the FDA's Regenerative Medicine Advanced Therapy pathway. It reflects a broader shift toward targeted biological interventions for patients who do not achieve success with standard care protocols.
While these trial results offer a look at potential new treatment options for persistent foot ulcers, the therapy remains under regulatory review. If you or a family member are managing diabetic foot ulcers, consult your physician about standard care options and clinical trial eligibility.
The takeaway
The upcoming presentation offers a detailed look at how regenerative technology may soon assist in treating chronic diabetic wounds. Patients are encouraged to track developments regarding FDA status and discuss current evidence-based wound care options with their healthcare team.
What happens next
The trial results will be presented at the SAWC Fall conference on October 16, 2026. The FDA is expected to announce a decision on the SkinTE Biologics License Application by March 16, 2027.
Further reading
Learn more about current Diabetes care and management strategies on our site.
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