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NCT04176120 · ClinicalTrials.gov registry record · Phase 3
Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU)
A Phase 3 study, sponsored by BioTissue Holdings.
- Completed
- Registry status
- Phase 3
- Development phase
- 220
- Enrollment target
NCT04176120: Completed Phase 3 study, sponsored by BioTissue Holdings.
NCT04176120 is a Phase 3 study that has completed, run by BioTissue Holdings. The registered enrollment target is 220 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04176120, a Phase 3 study, has completed, sponsored by BioTissue Holdings.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 220 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Time from baseline to initial observation of healing, where healing has been confirmed at two consecutive visits each two weeks apart.
Interventions
- OTHER Standard Care
- BIOLOGICAL TTAX01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2024-06-12 |
| Phase | Phase 3 |
What the finished NCT04176120 record still lists
NCT04176120 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard Care is the first listed.
NCT04176120 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04176120 about?
NCT04176120 is a clinical study titled "Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU)". 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 ...
What is the current status of trial NCT04176120?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2020-07-01. Estimated completion is 2024-06-12.
What interventions are being tested in trial NCT04176120?
The interventions under investigation include: Standard Care (OTHER), TTAX01 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04176120?
This trial is sponsored by BioTissue Holdings, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04176120's enrollment target sits among peer trials
220 1318th of 2000 higher than 672 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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