The trials will evaluate the SkinTE’s effectiveness in treating diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). SkinTE is a human cellular and tissue-based product designed to regenerate full-thickness, functional skin for skin repair, reconstruction and replacement. The Salt Lake City, Utah-based company has said the product produces full-thickness skin that has sweat glands and can grow hair. SkinTE has launched regionally.
Dr. David Armstrong, a surgery professor at the University of Southern California and founder of the Southwestern Academic Limb Salvage Alliance, is principal investigator for the concurrent trials, which will evaluate patient outcomes following treatment with SkinTE in DFUs and VLUs compared to the standard of care.
“Patients and providers both struggle to find adequate solutions for chronic wounds, with DFUs and VLUs being painful, prone to infection and challenging to treat using current standards of care,” said PolarityTE chief scientific officer Dr. Nikolai Sopko in a prepared statement. “We are encouraged by our chronic wound pilot evaluation studies initiated last year, and we look forward to further evaluating the efficacy of SkinTE in treating chronic wounds through randomized controlled trials.”
PolarityTE revealed last month that it is the target of an SEC investigation into possible violations of federal securities laws. The company has said that it plans to fully cooperate with the SEC during its investigation.