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NCT04450693 · ClinicalTrials.gov registry record · Phase 3
Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)
A Phase 3 study, sponsored by BioTissue Holdings.
- Completed
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
NCT04450693: Completed Phase 3 study, sponsored by BioTissue Holdings.
NCT04450693 is a Phase 3 study that has completed, run by BioTissue Holdings. The registered enrollment target is 106 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04450693, a Phase 3 study, has completed, sponsored by BioTissue Holdings.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 106 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, 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.
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 | 106 participants |
| Start Date | 2020-11-20 |
| Est. Completion | 2025-03-24 |
| Phase | Phase 3 |
What the finished NCT04450693 record still lists
NCT04450693 is an interventional study that assigns participants to a tested intervention. The registered 106 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 (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard care is the first listed.
NCT04450693 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04450693 about?
NCT04450693 is a clinical study titled "Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)". 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 withi...
What is the current status of trial NCT04450693?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2020-11-20. Estimated completion is 2025-03-24.
What interventions are being tested in trial NCT04450693?
The interventions under investigation include: Standard care (OTHER), TTAX01 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04450693?
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 NCT04450693's enrollment target sits among peer trials
106 1666th of 2000 higher than 331 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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