PolarityTE Inc announces the final results from a pilot study on the use of its SkinTE product for diabetic foot ulcers (DFUs). The data was presented recently at the American Diabetes Association’s 79th Scientific Sessions conference.
SkinTE is an 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.
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, 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, a media release from PolarityTE explains.
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 8 weeks of SkinTE application, and the mean time to heal was 29.7 days. One patient was removed from the study at week 3 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,” says Nikolai Sopko, MD, PhD, chief scientific officer of PolarityTE, in the release.
The abstract will be published in the online supplement to the journal Diabetes later this year. The presented poster is available on the PolarityTE website.
[Source(s): PolarityTE Inc, PR Newswire]