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NCT03230175 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01)
A Phase 2 study, sponsored by BioTissue Holdings.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT03230175: Completed Phase 2 study, sponsored by BioTissue Holdings.
NCT03230175 is a Phase 2 study that has completed, run by BioTissue Holdings. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03230175, a Phase 2 study, has completed, sponsored by BioTissue Holdings.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
It is hypothesized that application of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer will, with concomitant management of infection, result in a higher proportion of wounds showing complete healing within 16 weeks of initiating therapy.
Primary Outcome
Proportion of subjects with complete wound healing observed over the 16-week treatment period. Complete wound healing was defined as an initial observation of closure, followed by two confirmatory visits two weeks apart.
Interventions
- BIOLOGICAL TTAX01
- PROCEDURE Surgical resection and debridement
- DRUG Systemic antibiotics
- DEVICE Off-loading
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-10-04 |
| Est. Completion | 2019-04-01 |
| Phase | Phase 2 |
What the finished NCT03230175 record still lists
NCT03230175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 4 interventions - of which TTAX01 is the first listed.
NCT03230175 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03230175 about?
NCT03230175 is a clinical study titled "Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01)". It is hypothesized that application of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer will, with concomitant management of infection, result in a higher proportion of wounds showing complete healing within 16 weeks of initiating therap...
What is the current status of trial NCT03230175?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2017-10-04. Estimated completion is 2019-04-01.
What interventions are being tested in trial NCT03230175?
The interventions under investigation include: TTAX01 (BIOLOGICAL), Surgical resection and debridement (PROCEDURE), Systemic antibiotics (DRUG), Off-loading (DEVICE).
Who is sponsoring clinical trial NCT03230175?
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 NCT03230175's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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