Final Clinical Results from Pilot Study Showing Closure of Diabetic Foot Ulcers Using SkinTE™

SkinTE™ is a first-of-its-kind autologous, homologous human cellular and tissue-based product designed to regenerate full-thickness, functional skin for the repair, reconstruction and replacement of a patient's own skin.

Monday, October 14, 2019

PolarityTE announces the final results from a pilot study on the use of its SkinTE™ product for hard-to-treat diabetic foot ulcers (DFUs). The data was presented at the American Diabetes Association’s 79th Scientific Sessions conference. SkinTE™ is a first-of-its-kind autologous, homologous human cellular and tissue-based product designed to regenerate full-thickness, functional skin for the repair, reconstruction and replacement of a patient’s own skin.  PolarityTE, Inc. (Nasdaq: PTE) is a biotechnology company developing and commercializing regenerative tissue products and biomaterials.

The poster, Results of a Pilot Evaluation of a Novel Autologous Homologous Skin Construct Treatment of Diabetic Foot Wounds Refractory to Conventional Treatments, which was authored and presented by David G. Armstrong, MD, PhD, DPM, Professor of Clinical Surgery at the Keck School of Medicine at the University of Southern California and co-Director of the Southwestern Academic Limb Salvage Alliance on June 9, highlighted data from a study evaluating the efficacy, safety and durability of a single application of SkinTE to close DFUs that had not healed with conventional treatment strategies. The pilot study, which included 11 patients with type 2 diabetes and Wagner 1 and 2 DFUs, also served as a feasibility study for a larger randomized controlled trial comparing treatment of DFUs with SkinTE to the standard of care that began enrolling earlier this year (clinicaltrials.gov: NCT03881254).

The results of the study included the healing of all harvest sites and complete SkinTE graft take one week after SkinTE™ application. Ten of the 11 patients (90.9%) had healed DFUs within eight weeks of SkinTE application and the mean time to heal was 29.7 days. One patient was removed from the study at week three due to adverse events not related to the study or SkinTE procedure. The pilot study results suggest that a single application of SkinTE is capable of closing difficult to treat Wagner 1 and 2 DFUs and that the product can be successfully employed in the clinic setting using normal work flows.

“Diabetic foot ulcers are challenging for patients and the overall health care system, and despite the countless products on the market, many patients struggle to achieve good outcomes. In this study, some of the most challenging wounds in the chronic wound-care market healed after a single application of SkinTE, where other standard treatments had failed,” said Nikolai Sopko, MD, PhD, Chief Scientific Officer of PolarityTE. “We hope this clinical data continues to help build provider confidence in SkinTE as a viable alternative to treating patients with DFUs by demonstrating its ability to achieve better outcomes over current standards.”

The abstract will be published in the online supplement to the journal Diabetes later this year. The presented poster is available here.

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