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