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Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers
NCT05586542 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05586542
The ClinicalTrials.gov registry entry for NCT05586542 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vitruvian Medical Devices, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05586542 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Florida, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05586542?
The interventions under investigation include: Standard of Care (OTHER), DERMASEAL (COMBINATION_PRODUCT), Plasma Film (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05586542?
This trial is sponsored by Vitruvian Medical Devices, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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