SkinTE® Met Primary and Secondary Endpoints in Final Analysis from Diabetic Foot Ulcer Trial

SALT LAKE CITY–(BUSINESS WIRE)–PolarityTE, Inc. (Nasdaq: PTE) today announced final data from a multi-center randomized controlled trial evaluating treatment of Diabetic Foot Ulcers (DFU) with its investigational product SkinTE® plus standard of care (SOC) vs SOC alone (NCT03881254). The trial met the primary endpoint of wound closure at 12 weeks and secondary endpoint of Percent Area Reduction (PAR) assessed at 4, 6, 8, 10, and 12 weeks. 100 participants were evaluated across 13 sites with 50 participants receiving SkinTE plus SOC and 50 receiving SOC alone. PolarityTE is pleased to announce today the final analysis of the full data set, which includes:

  • Primary Endpoint: 70% (35/50) of participants receiving SkinTE plus SOC had wound closure at 12 weeks versus 34% (17/50) of participants receiving SOC alone (p=0.00032)
  • Secondary Endpoint: Percent Area Reduction (PAR) assessed at 4, 6, 8, 10, and 12 weeks was significantly greater for the SkinTE plus SOC treatment group vs SOC alone (p=0.009)
  • 90% (45/50) of SkinTE plus SOC treated participants received a single application of SkinTE
  • Treatment with SkinTE plus SOC increased the odds of wound closure by 5.37 times versus SOC (p=0.001)

Mean (SD) values for PAR at weeks 4, 6, 8, 10, and 12 by treatment group

Week

SkinTE

SOC

4

74.0 (27.63)

22.0 (149.92)

6

82.9 (26.35)

21.2 (160.60)

8

80.7 (35.16)

26.8 (147.42)

10

79.7 (54.07)

45.6 (114.18)

12

84.3 (39.46)

50.5 (92.24)

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