SkinTE Trial Results Will Debut in October 2026
The Symposium on Advanced Wound Care will feature Phase 3 clinical data on a new diabetic foot ulcer treatment.
Updated on Sept. 29, 2026 in Diabetes
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The Phase 3 COVER DFUS II trial results for SkinTE will be unveiled during a First-to-Podium presentation on October 16, 2026. This trial evaluated the efficacy of the autologous cutaneous multicellular units product in treating diabetic foot ulcers.
Why it matters
The study aims to address the challenges of non-healing diabetic foot ulcers by isolating patients with advanced pathology. These findings will play a critical role as the FDA reviews the Biologics License Application for the product.
The study randomized 120 patients after a two-week run-in period, requiring participants to show less than 30% wound size decrease. The trial measured the primary efficacy endpoint of complete wound closure within a 12-week window.
The players
Robert S. Kirsner
He serves as the Study Chair for the COVER DFUS II trial.
PolarityBio
This company is the developer of the SkinTE product and is based in Salt Lake City.
FDA
The federal agency is responsible for reviewing the Biologics License Application for SkinTE.
The details
The COVER DFUS II trial utilized a rigorous run-in period to ensure the inclusion of true non-healing wounds in its 120-patient cohort. Participants were divided between those receiving SkinTE combined with standard care and those receiving standard care alone to assess performance.
Timeline
October 15-18, 2026: SAWC Fall conference in Las Vegas.
October 16, 2026: First-to-Podium presentation of trial results.
March 16, 2027: PDUFA target date for FDA BLA decision.
Health Landscape
The development of SkinTE aligns with the regulatory framework set by the FDA's Regenerative Medicine Advanced Therapy designation. This trial represents a specific effort to advance standard care for diabetic foot ulcers using autologous cutaneous multicellular units.
The eventual regulatory approval of SkinTE could offer a new treatment option for patients struggling with chronic diabetic foot ulcers. For now, patients remain reliant on existing standard-of-care protocols while awaiting the results of the ongoing BLA review.
The takeaway
Advancements in regenerative medicine continue to target complex wounds that do not respond to traditional standard-of-care treatments. Patients and providers should monitor the upcoming FDA BLA decision for updates on treatment availability.
What happens next
The First-to-Podium presentation of trial results will occur on October 16, 2026, during the SAWC Fall conference. Following the clinical presentation, the FDA is scheduled to issue a decision on the Biologics License Application by the March 16, 2027, PDUFA date.
Further reading
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