Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to determine the safety of DERMASEAL for the treatment of non-healing, neuropathic diabetic foot ulcers. The main outcome measure is safety. A total of twenty-four (24) participants will be randomized to receive up to four (4) consecutive weeks of treatment with either standard of care (SOC), plasma film + SOC, or plasma film containing silver microparticles (DERMASEAL) + SOC, with a final follow-up visit 12 weeks after the last treatment.

Clinical Trial Description

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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05586542
Study type	Interventional
Source	Vitruvian Medical Devices, Inc.
Contact	Hobart W Harris, MD, MPH
Phone	(415) 514-3891
Email	hobart.harris@ucsf.edu
Status	Recruiting
Phase	Phase 1
Start date	October 3, 2022
Completion date	October 31, 2023

View Details

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