Reports Peer-Reviewed Publication of Interim Results from Diabetic Foot Ulcer Trial in International Wound Journal
PolarityTE, Inc. (NASDAQ:PTE) today announced preliminary topline data demonstrating that a multi-center randomized controlled trial evaluating treatment of Diabetic Foot Ulcers with SkinTE® plus standard of care (SOC) vs SOC alone (NCT03881254) met the primary endpoint of wound closure at 12 weeks and secondary endpoint of Percent Area Reduction (PAR) at 12 weeks. 100 patients were evaluated across 13 sites with 50 patients receiving SkinTE plus SOC and 50 patients receiving SOC alone.
Primary Endpoint: 70% (35/50) of patients receiving SkinTE plus SOC had wound closure at 12 weeks versus 34% (17/50) of patients receiving SOC alone—p=0.00032
Secondary Endpoint: Percent Area Reduction (PAR) at 12 weeks was significantly greater for the SkinTE plus SOC treatment group (84.4%) vs SOC alone (53.5%)—p=0.00024
The results from this fully-enrolled 100 patient trial will be issued via a poster presentation entitled, "Topline Results: 100 Patient Randomized Controlled Trial to Evaluate the Treatment of Diabetic Foot Ulcers with a Novel Autologous Heterogeneous Skin Construct" and available to those attending the Symposium on Advanced Wound Care (SAWC) Spring Conference held virtually May 10-14, 2021. PolarityTE also plans to discuss the topline results during the Company's upcoming earnings call scheduled for May 13, 2021 at 4:30 p.m. Eastern Time. The conference call can be accessed by dialing 1-800-377-1217 (U.S. and Canada) or +44 (0)330 027 2386 (International) with confirmation code 231666 and referencing "PolarityTE First Quarter 2021 Earnings Call". A webcast of the conference call can be accessed by using the link below.