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NCT05586542
Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers
Phase 1 trial testing DERMASEAL in Foot Ulcer, Diabetic in 26 participants. Participants enrolled and being followed up; not accepting new ones.
30 March 2025
Quick facts
| Lead sponsor | Vitruvian Medical Devices, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 26 |
| Start date | 3 October 2022 |
| Primary completion | 30 March 2025 |
| Estimated completion | 30 April 2025 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- DERMASEAL
- Plasma Film — full drug profile →
- Standard of Care
Conditions studied
- Foot Ulcer, Diabetic — all drugs for Foot Ulcer, Diabetic →
Sponsor
Vitruvian Medical Devices, Inc. — full company profile →
Who can join
21 and older, any sex, with Foot Ulcer, Diabetic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05586542
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of DERMASEAL
Trials testing the same drug.
- NCT06134843 — Study to Assess the Safety and Efficacy of DERMASEAL for the Treatment of Split-Thickness Skin Graft Donor Site Wounds · Phase 1, PHASE2 · not yet recruiting
Other recruiting trials for Foot Ulcer, Diabetic
Currently open trials in the same condition.
- NCT06487780 — Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers · NA · recruiting
- NCT04210089 — Total Contact Soft Cast in Diabetic Foot Ulcers · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05586542 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vitruvian Medical Devices, Inc.
- Last refreshed: 27 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05586542.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing