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NCT06140303 · ClinicalTrials.gov registry record · Phase 3
SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II)
A Phase 3 study of Diabetic Foot, sponsored by PolarityTE.
- Active
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT06140303: Active Phase 3 study of Diabetic Foot, sponsored by PolarityTE.
NCT06140303 is a Phase 3 study of Diabetic Foot that is active but no longer recruiting, run by PolarityTE. The registered enrollment target is 100 participants, below the 10,338-participant average among 30 other Diabetic Foot trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06140303, a Phase 3 study of Diabetic Foot, is active but no longer recruiting, sponsored by PolarityTE.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers.
Primary Outcome
Wound closure is confirmed at two consecutive visits each two weeks apart
Conditions Studied
Interventions
- OTHER Control
- BIOLOGICAL SkinTE
Study Locations (20)
California
- Center for Clinical Research - Castro Valley
- Limb Preservation Platform, Inc. - Fresno
- Angel City Research - Los Angeles
- Clemente Clinical Research Inc. - Los Angeles
- Center for Clinical Research - San Francisco
- Clemente Clinical Research Inc. - Santa Ana
- ILD Research - Vista
Florida
- Las Mercedes Medical Research, Inc. - Hialeah
- Doctors Research Network - Miami
- DMI Research - Pinellas Park
- Barry University Clinical Research - Tamarac
Ohio
- LEIRT (Lower Extremity Institute for Research and Therapy) - Boardman
- Cutting Edge Research LLC - Circleville
- LEIRT (Lower Extremity Institute for Research and Therapy) - East Liverpool
- Cutting Edge Research LLC - Grove City
New York
- Northwell Health, Inc. - New Hyde Park
- Mount Sinai West Hospital - New York
Arizona
- Titan Clinical Research - Mesa
Maryland
- FASMA - Hagerstown - Hagerstown
Nevada
- Viable Research Management - Henderson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-02-22 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 3 |
What the registry record for NCT06140303 still lists
NCT06140303 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 10,338-participant average among 30 other Diabetic Foot trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Diabetic Foot appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.
NCT06140303 names 20 study sites across 7 states, led by California, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT06140303 about?
NCT06140303 is a clinical study titled "SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II)". The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers.
What is the current status of trial NCT06140303?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2024-02-22. Estimated completion is 2026-03-31.
What conditions does trial NCT06140303 study?
This clinical trial studies the following conditions: Diabetic Foot.
What interventions are being tested in trial NCT06140303?
The interventions under investigation include: Control (OTHER), SkinTE (BIOLOGICAL).
Who is sponsoring clinical trial NCT06140303?
This trial is sponsored by PolarityTE, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06140303 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Maryland, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Foot
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 NCT06140303's enrollment target sits among peer trials
100 20th of 30 higher than 10 of 30 other Diabetic Foot trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot 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
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A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
RECRUITING · Phase 4
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