A first pivotal study is a multi-center, randomized controlled trial evaluating SkinTE in the treatment of diabetic foot ulcers (DFU)
Latest Information Update: 26 Feb 2025
At a glance
- Drugs Autologous cell therapy-PolarityTE (Primary)
- Indications Diabetic foot ulcer
- Focus Registrational; Therapeutic Use
- Acronyms COVER DFUs; COVER DFUS II
- Sponsors PolarityBio
Most Recent Events
- 20 Feb 2025 According to PolarityTE media release, over 75% patients enrolled with topline interim results expected in Q1 2025 and final results in Q1 2026.
- 03 Dec 2024 According to PolarityTE media release, the company expects to complete enrollment in the 1st half of 2025. The company has enrolled 65 subjects toward the target of 120 subjects for performing interim analysis on the trial's 12-week primary endpoint.
- 03 Dec 2024 According to a PolarityBio media release, the company has surpassed the interim enrollment target for SkinTE's Phase III Pivotal Study in the treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II).