drugset / Trial / NCT05586542
Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DERMASEAL | Unknown | — | Topical |
| Subject | Plasma Film | Unknown | — | Topical |