NCT05586542

Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Study to Assess the Safety of DERMASEAL Advanced Wound Care Dressing for the Treatment of Chronic Non-healing, Neuropathic Diabetic Foot Ulcers

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Vitruvian Medical Devices, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Foot Ulcer, Diabetic

Interventions

Type	Name	Description
COMBINATION_PRODUCT	DERMASEAL	a novel skin substitute formulated as planar, thin film
BIOLOGICAL	Plasma Film	a planar, thin film made from human plasma
OTHER	Standard of Care	standard procedures for managing diabetic foot ulcers including debridement of unhealthy tissue and maintenance of a moist wound environment

Timeline

• Start date: 2022-10-03
• Primary completion: 2025-03-30
• Completion: 2025-04-30
• First posted: 2022-10-19
• Last updated: 2024-12-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study