PolarityTE Inc. (PTE) said that SkinTE met primary and secondary endpoints in final analysis from diabetic foot ulcer trial.
The multi-center randomized controlled trial, which evaluates treatment of Diabetic Foot Ulcers (DFU) with its investigational product SkinTE plus standard of care compared to standard of care alone, met the primary endpoint of wound closure at 12 weeks.
The trial also met the secondary endpoint of Percent Area Reduction (PAR) assessed at 4, 6, 8, 10, and 12 weeks.
The company noted that 100 participants were evaluated across 13 sites with 50 participants receiving SkinTE plus standard of care or SOC and 50 receiving standard of care alone.
The company said 70% of participants receiving SkinTE plus SOC had wound closure at 12 weeks versus 34% (17/50) of participants receiving SOC alone.
The company noted that Percent Area Reduction assessed at 4, 6, 8, 10, and 12 weeks was significantly greater for the SkinTE plus SOC treatment group vs SOC alone.90% of SkinTE plus SOC treated participants received a single application of SkinTE, the company said.
In addition, PolarityTE announced a randomized controlled trial evaluating SkinTE versus SkinTE plus SOC in Venous Leg Ulcers (VLUs) has been completed with a total of 29 enrolled participants. Data from the VLU trial will be announced via press release in the second half of 2021.
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