Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU)
Public ClinicalTrials.gov record NCT04176120. 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 Multicenter Phase 3 Trial of Biotherapy Using Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
It is hypothesized that application at 4-week or greater intervals of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer (DFU) will, with concomitant management of infection, will result in a higher rate of wounds showing complete healing within 26 weeks of initiating therapy, compared with standard care alone. This confirmatory Phase 3 study examines a population of diabetic foot ulcer patients having adequate perfusion, with or without neuropathy, and a high suspicion of associated osteomyelitis in a complex, high grade wound.
Study identification
- NCT ID
- NCT04176120
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 220 participants
Conditions and interventions
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
- Jul 1, 2020 (Actual)
- Primary completion
- Jan 25, 2024 (Actual)
- Completion
- Jun 12, 2024 (Actual)
- Last update posted
- Jun 14, 2024
2020 – 2024
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Center for Clinical Research, Inc | San Francisco | California | 94117 | — |
| UCLA Olive View | Sylmar | California | 91342 | — |
| University of Miami | Miami | Florida | 33125 | — |
| Paley Orthopedic & Spine Institute | West Palm Beach | Florida | 33407 | — |
| Rosalind Franklin University | North Chicago | Illinois | 60064 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| Mount Sinai West | New York | New York | 10019 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| University Hospitals Richmond Medical Center | Richmond Heights | Ohio | 44143 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| JPS | Fort Worth | Texas | 76104 | — |
| Futuro Clinical Trials, LLC | McAllen | Texas | 78501 | — |
| Bio-X-Cell Research | San Antonio | Texas | 78224 | — |
| Foot & Ankle Institute | St. George | Utah | 84470 | — |
| Carilion Clinic | Roanoke | Virginia | 24013 | — |
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 NCT04176120, 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 Jun 14, 2024 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04176120 live on ClinicalTrials.gov.