Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers

Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers

A double-blind, randomized, placebo-controlled, multi-center, phase 1 study to evaluate the safety of the DERMASEAL advanced wound care dressing in the treatment of non-healing diabetic foot ulcers located distal to the malleolus in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation. Subjects will be randomized in a 1:1:2 ratio to one of 3 treatment groups:

  • SOC alone (n=6)
  • SOC + plasma film (n=6)
  • SOC + DERMASEAL (n=12)

A subject’s study duration will be up to a total of 18 weeks from screening to end of study. This includes a two-week active run-in followed by up to 4 weeks of treatment, plus a final follow-up visit 12 weeks after the last treatment.

The primary endpoint is safety of topically applying a plasma film containing metallic silver microparticles plus fibrin in patients with chronic, non-healing neuropathic diabetic foot ulcers. Secondary endpoints to be assessed in each group include:

  1. Percent of study wounds healed during the post-treatment weeks 1 through 4,
  2. Time to complete wound closure,
  3. Percent area reduction during the post-treatment weeks 2, 4, 6 and 16, and
  4. Cost of treatment

Source: View full study details on

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October 20, 2022Comments | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine