Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05586542 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers
A Phase 1 study of Foot Ulcer, Diabetic, sponsored by Vitruvian Medical Devices.
- Active
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 4
- Study locations
NCT05586542: Active Phase 1 study of Foot Ulcer, Diabetic, sponsored by Vitruvian Medical Devices.
NCT05586542 is a Phase 1 study of Foot Ulcer, Diabetic that is active but no longer recruiting, run by Vitruvian Medical Devices. The registered enrollment target is 26 participants, below the 303-participant average among 8 other Foot Ulcer, Diabetic trials with a reported enrollment target (91% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05586542, a Phase 1 study of Foot Ulcer, Diabetic, is active but no longer recruiting, sponsored by Vitruvian Medical Devices.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
Review of adverse events associated with the topical application of a plasma film containing metallic silver microparticles in patients with chronic non-healing neuropathic diabetic foot ulcers.
Conditions Studied
Interventions
- OTHER Standard of Care
- COMBINATION_PRODUCT DERMASEAL
- BIOLOGICAL Plasma Film
Study Locations (4)
California
- Limb Preservation Platform, Inc. - Fresno
Florida
- Doctors Research Network - South Miami
Ohio
- Lower Extremity Institute for Research and Therapy, LLC - Boardman
Texas
- Futuro Clinical Trials, LLC - McAllen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2025-04-30 |
| Phase | Phase 1 |
What the registry record for NCT05586542 still lists
NCT05586542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 303-participant average among 8 other Foot Ulcer, Diabetic trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Foot Ulcer, Diabetic appearing as the primary indexed condition, and to 3 interventions - of which Standard of Care is the first listed.
NCT05586542 reports a single indexed study location in California, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT05586542 about?
NCT05586542 is a clinical study titled "Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers". 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 ei...
What is the current status of trial NCT05586542?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2022-10-03. Estimated completion is 2025-04-30.
What conditions does trial NCT05586542 study?
This clinical trial studies the following conditions: Foot Ulcer, Diabetic.
What interventions are being tested in trial NCT05586542?
The interventions under investigation include: Standard of Care (OTHER), DERMASEAL (COMBINATION_PRODUCT), Plasma Film (BIOLOGICAL).
Who is sponsoring clinical trial NCT05586542?
This trial is sponsored by Vitruvian Medical Devices, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05586542 being conducted?
This trial has 4 study locations across California, Florida, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Foot Ulcer, Diabetic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05586542's enrollment target sits among peer trials
26 9th of 8 the lowest of 8 other Foot Ulcer, Diabetic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Foot Ulcer, Diabetic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs
RECRUITING · NA
-
Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
RECRUITING · Phase 4
-
Total Contact Soft Cast in Diabetic Foot Ulcers
RECRUITING · NA
-
Diabetic Foot Ulcer Imaging- Study 2
RECRUITING · NA
-
Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers
RECRUITING · NA
-
Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.
RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02646475 · 26 participants · Phase 1
Metabolic Effects of Angiotensin-(1-7)
- NCT03603223 · 26 participants · Phase 2
Pembrolizumab in Treating Participants With Leukoplakia
- NCT04063592 · 26 participants · NA
AMI Construction in Lower Extremity Residual Limbs
- NCT04906460 · 26 participants · Phase 1
Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI