PolarityTE Initiates Phase III Study on SkinTE for Diabetic Ulcers

PolarityTE, a biotechnology firm based in Salt Lake City, Utah, has initiated a Phase III pivotal study known as "COVER DFUS II" to assess the efficacy of SkinTE in treating Wagner grade 1 diabetic foot ulcers (DFUs). The study aims to enroll approximately 120 participants across 20 clinical locations in the United States. Participants will be divided into two groups, with one receiving SkinTE in conjunction with the standard of care (SOC), and the other receiving SOC alone.

The primary goal of the study is to determine the rate at which DFUs heal within 12 weeks. Additional objectives include measuring the percent area reduction of the ulcers at various intervals, the total number of in-person wound care visits and hospital stays related to the ulcer, the duration of CAM Boot use, the time taken for the ulcer to close, and the proportion of participants experiencing adverse events between the two treatment arms.

Dr. Nikolai Sopko, Chief Operating and Scientific Officer at PolarityTE, expressed enthusiasm for the study, highlighting the biological exhaustion within the wound bed that often leads to persistent DFUs. He believes that SkinTE, which utilizes optimized healthy cells from the patient, could be instrumental in facilitating the closure of these challenging ulcers.

Dr. David Armstrong, a professor of surgery and director of the Southwestern Academic Limb Salvage Alliance (SALSA), emphasized the urgency and significance of the study. He pointed out that diabetic foot ulcers are a common and serious health issue, with a new case emerging every second. These patients face an immediate risk of amputation, hospitalization, and even death, making the evaluation of a promising therapy like SkinTE critical.

PolarityTE is developing regenerative tissue products, with SkinTE being one of their key offerings. The company has an open investigational new drug application (IND) for SkinTE in the treatment of DFUs with the U.S. Food and Drug Administration (FDA) and is now advancing towards pivotal studies that will support a biologics license application (BLA).