PolarityTE Commences Phase III Trial for SkinTE in Diabetic Foot Ulcers
Overview
- Company: PolarityTE
- Indication: Diabetic foot ulcers
- Drug: SkinTE
- Trial Phase: Phase 3
- NCT ID: Not provided
PolarityTE has initiated the first subject screening for their Phase III pivotal study, entitled 'COVER DFUS II', which investigates the use of their novel product SkinTE for the treatment of Wagner grade 1 diabetic foot ulcers (DFUs). The study aims to enroll approximately 120 participants across around 20 clinical sites in the United States.
Participants will be randomly assigned to one of two groups: one receiving a combination of SkinTE plus standard of care (SOC), and the other receiving just SOC.
The primary endpoint is the rate of ulcer closure by 12 weeks post-treatment. Secondary outcomes include the percentage of area reduction at 4, 8, and 12 weeks, the total number of clinic visits or hospital stays, the number of days a CAM Boot is used, the time required for ulcer closure within 24 weeks, and the proportion of subjects experiencing treatment-related adverse events.
Dr. Nikolai Sopko, COO and CSO of PolarityTE, highlighted the challenge of DFUs due to the often 'biologically spent' tissue in the wound bed. Dr. David Armstrong of the Keck School of Medicine also expressed his anticipation for the potential benefits of SkinTE.
PolarityTE is based in Salt Lake City, Utah, and develops regenerative tissue products like SkinTE. They hold an open IND with the FDA and aim to support their future biologics license application (BLA) with the results from ongoing pivotal studies. Currently, SkinTE is solely for investigational use. More information can be found on the PolarityTE website.