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)
Study identification
- NCT ID
- NCT04450693
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- BioTissue Holdings, Inc
- Industry
- Enrollment
- 106 participants
Conditions and interventions
Interventions
- Standard care Other
- TTAX01 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
- Nov 19, 2020
- Primary completion
- Mar 23, 2025
- Completion
- Mar 23, 2025
- Last update posted
- Mar 31, 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 Mar 31, 2025 · Synced May 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04450693 live on ClinicalTrials.gov.