PolarityTE Inc. (PTE) said that a multi-center randomized controlled trial evaluating treatment of Diabetic Foot Ulcers with SkinTE plus standard of care compared to standard of care alone met the primary endpoint of wound closure at 12 weeks and secondary endpoint of Percent Area Reduction or PAR at 12 weeks.
The company said 100 patients were evaluated across 13 sites with 50 patients receiving SkinTE plus standard of care and 50 patients receiving standard of care alone.
The company noted that 70% of patients receiving SkinTE plus standard of care had wound closure at 12 weeks versus 34% of patients receiving standard of care alone.
PolarityTE said percent area reduction at 12 weeks was significantly greater for the SkinTE plus standard of care treatment group (84.4%) vs standard of care alone (53.5%).
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