(RTTNews) – PolarityTE Inc. (PTE) announced positive results from a protocol-specified interim analysis of the first 50 patients enrolled in a multi-center randomized controlled trial evaluating treatment of Diabetic Foot Ulcers with SkinTE plus standard of care or SOC vs SOC alone.
The company stated that 50 patients were evaluated across 13 sites with 25 patients receiving SkinTE plus SOC and 25 patients receiving only SOC.
The company stated that demographics were well balanced between treatment groups with no statistically significant differences.
The company noted that all SkinTE patients received only one application of the product, except two patients who received a reapplication due to inadvertent removal of the original product.
PolarityTE said that 72% of patients treated with SkinTE plus SOC achieved wound closure by 12 weeks vs 32% of patients treated with SOC alone.
According to the company, preliminary analysis showed that SkinTE treatment did not result in more Adverse Events (AEs) than SOC.