Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers
Public ClinicalTrials.gov record NCT05586542. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Study to Assess the Safety of DERMASEAL Advanced Wound Care Dressing for the Treatment of Chronic Non-healing, Neuropathic Diabetic Foot Ulcers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05586542
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 26 participants
Conditions and interventions
Conditions
Interventions
- DERMASEAL Combination Product
- Plasma Film Biological
- Standard of Care Other
Combination Product · Biological · Other
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 3, 2022 (Actual)
- Primary completion
- Mar 30, 2025 (Estimated)
- Completion
- Apr 30, 2025 (Estimated)
- Last update posted
- Dec 27, 2024
2022 – 2025
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Limb Preservation Platform, Inc. | Fresno | California | 93710 | — |
| Doctors Research Network | South Miami | Florida | 33143 | — |
| Lower Extremity Institute for Research and Therapy, LLC | Boardman | Ohio | 44512 | — |
| Futuro Clinical Trials, LLC | McAllen | Texas | 78501 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05586542, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 27, 2024 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05586542 live on ClinicalTrials.gov.