drugset / Trial / NCT05586542

Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers

NCT05586542 ↗

Phase 1 Active not recruiting 26 enrolled Vitruvian Medical Devices, Inc.
RandomizedParallel-groupQuadruple-blindOther

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.

Timeline

Start
2022-10-03
Primary completion
2025-03-30
Completion
2025-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject DERMASEAL Unknown — Topical
Subject Plasma Film Unknown — Topical

Indications