Pilot Study Shows Closure of DFUs with Autologous Product

Data presented at the American Diabetes Association’s 79th Scientific Sessions conference in San Francisco, California, suggest that a single application of SkinTE by PolarityTE (Salt Lake City, UT) is capable of closing difficult-to-treat diabetic foot ulcers (DFUs). The pilot study, authored by David G. Armstrong, MD, PhD, DPM, followed 11 patients with type 2 diabetes mellitus and a Wagner grade 1 or 2 DFU treated with SkinTE. Ten of 11 patients healed DFUs within 8 weeks of the graft application, with a mean time to heal of 29.7 days. The product has the potential to be successfully employed in the clinical setting as an alternative to current standard of care.

The first-of-its-kind autologous, homologous human cellular- and tissue-based product (CTP) is designed to regenerate full-thickness skin from the patient’s own tissues. This particular study served as a feasibility study for a larger trial comparing SkinTE to standard of care (clinicaltrials.gov: NCT03881254).

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