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NCT03818828 · ClinicalTrials.gov registry record · Phase 2
Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01)
A Phase 2 study, sponsored by BioTissue Holdings.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT03818828: Completed Phase 2 study, sponsored by BioTissue Holdings.
NCT03818828 is a Phase 2 study that has completed, run by BioTissue Holdings. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03818828, a Phase 2 study, has completed, sponsored by BioTissue Holdings.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
It is hypothesized that application at 4-week intervals of the human umbilical cord tissue TTAX01 to the surface of a well debrided, nonhealing venous leg ulcer (VLU) will result in a high proportion of wounds showing complete healing within 12 weeks of initiating therapy. This open label pilot study provides a framework for a larger, controlled study. The purposes for conducting this study are to evaluate the functionality of the protocol and to obtain an estimate of product safety and efficacy when applied according to the protocol instructions, and measured according to the stated endpoints.
Primary Outcome
Proportion of subjects who achieve complete wound closure over the 12-week treatment period from baseline with a 4 week followup to confirm wound healing.
Interventions
- BIOLOGICAL TTAX01
- OTHER Profore Compression Therapy
- OTHER Cadexomer Iodine dressing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2019-02-14 |
| Est. Completion | 2020-01-28 |
| Phase | Phase 2 |
What the finished NCT03818828 record still lists
NCT03818828 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which TTAX01 is the first listed.
NCT03818828 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03818828 about?
NCT03818828 is a clinical study titled "Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01)". It is hypothesized that application at 4-week intervals of the human umbilical cord tissue TTAX01 to the surface of a well debrided, nonhealing venous leg ulcer (VLU) will result in a high proportion of wounds showing complete healing within 12 weeks of initiating therapy. This open label pilot stud...
What is the current status of trial NCT03818828?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2019-02-14. Estimated completion is 2020-01-28.
What interventions are being tested in trial NCT03818828?
The interventions under investigation include: TTAX01 (BIOLOGICAL), Profore Compression Therapy (OTHER), Cadexomer Iodine dressing (OTHER).
Who is sponsoring clinical trial NCT03818828?
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 NCT03818828's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 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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