drugset / Trial / NCT06140303
SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II)
Phase 3
Active not recruiting
100 enrolled
PolarityTE
Professional Education and Research Institute · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers.
Timeline
- Start
- 2024-02-22
- Primary completion
- 2025-12-31
- Completion
- 2026-03-31
Outcome
Met primary endpoint
release “The submission follows the successful completion of the pivotal Phase III trial, COVER DFUS II, which met its primary efficacy endpoint of complete wound closure.” polaritybio.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SkinTE | Cell therapy | — | — |
Indications
No indication recorded.