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 ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

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