Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)
Public ClinicalTrials.gov record NCT04450693. 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 Confirmatory Trial of Biotherapy Using Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)
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, result in a higher rate of wounds showing complete healing within 25 weeks of initiating therapy, compared with standard care alone. This second 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
- NCT04450693
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 106 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
- Nov 20, 2020 (Actual)
- Primary completion
- Mar 24, 2025 (Actual)
- Completion
- Mar 24, 2025 (Actual)
- Last update posted
- Apr 1, 2025
2020 – 2025
United States locations
- U.S. sites
- 16
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| LakeView Clinical Research | Guntersville | Alabama | 35976 | — |
| Banner University Medical Center Tucson | Tucson | Arizona | 85724 | — |
| Clemente Clinical Research | Los Angeles | California | 90033 | — |
| VA Northern California Health Care System | Mather | California | 95655 | — |
| CureCentric | Palmdale | California | 93551 | — |
| PIH Health | Whittier | California | 90606 | — |
| Midland Florida Clinical Research Center | DeLand | Florida | 32720 | — |
| Delray Physician Care Center | Delray Beach | Florida | 33445 | — |
| Gateway Clinical Trials, LLC | O'Fallon | Illinois | 62269 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Reno Orthopedic Clinic | Reno | Nevada | 89503 | — |
| Curalta Foot and Ankle | Westwood | New Jersey | 07675 | — |
| Cutting Edge Research, LLC | Circleville | Ohio | 43113 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Advantage Foot Care of Houston | Houston | Texas | 77074 | — |
| Biolife Genetics Research | Houston | Texas | 77095 | — |
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 NCT04450693, 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 Apr 1, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04450693 live on ClinicalTrials.gov.