SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II)
Public ClinicalTrials.gov record NCT06140303. 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
Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers. Closure Obtained With Vascularized Epithelial Regeneration for DFUs With SkinTE® II (COVER DFUS II)
Study identification
- NCT ID
- NCT06140303
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- PolarityTE
- Industry
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Interventions
- Control Other
- SkinTE Biological
Other · Biological
Eligibility (public fields only)
- Age range
- 18 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
- Feb 21, 2024
- Primary completion
- Dec 30, 2025
- Completion
- Mar 30, 2026
- Last update posted
- Jul 10, 2025
2024 – 2026
United States locations
- U.S. sites
- 23
- U.S. states
- 9
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Titan Clinical Research | Mesa | Arizona | 85202 | — |
| Center for Clinical Research | Castro Valley | California | 94546 | — |
| Limb Preservation Platform, Inc. | Fresno | California | 93710 | — |
| Angel City Research | Los Angeles | California | 90010 | — |
| Clemente Clinical Research Inc. | Los Angeles | California | 92704 | — |
| Center for Clinical Research | San Francisco | California | 94115 | — |
| Clemente Clinical Research Inc. | Santa Ana | California | 92704 | — |
| ILD Research | Vista | California | 92081 | — |
| Las Mercedes Medical Research, Inc. | Hialeah | Florida | 33010 | — |
| Doctors Research Network | Miami | Florida | 33156 | — |
| DMI Research | Pinellas Park | Florida | 33782 | — |
| Barry University Clinical Research | Tamarac | Florida | 33321 | — |
| FASMA - Hagerstown | Hagerstown | Maryland | 21742 | — |
| Viable Research Management | Henderson | Nevada | 89014 | — |
| Northwell Health, Inc. | New Hyde Park | New York | 11042 | — |
| Mount Sinai West Hospital | New York | New York | 10019 | — |
| LEIRT (Lower Extremity Institute for Research and Therapy) | Boardman | Ohio | 44512 | — |
| Cutting Edge Research LLC | Circleville | Ohio | 43123 | — |
| LEIRT (Lower Extremity Institute for Research and Therapy) | East Liverpool | Ohio | 43920 | — |
| Cutting Edge Research LLC | Grove City | Ohio | 43123 | — |
| Perfizien Clinical Research LLC. | Houston | Texas | 77055 | — |
| Baylor Scott & White Health | Plano | Texas | 75093 | — |
| Foot and Ankle Specialists of the Mid-Atlantic | Salem | Virginia | 24153 | — |
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 NCT06140303, 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 Jul 10, 2025 · Synced May 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06140303 live on ClinicalTrials.gov.