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NCT04134143 · ClinicalTrials.gov registry record · Phase 1
Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers
A Phase 1 study, sponsored by Stratatech, a Mallinckrodt Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT04134143: Clinical Trial Phase 1 study, sponsored by Stratatech, a Mallinckrodt Company.
NCT04134143 is a Phase 1 study that was terminated before completion, run by Stratatech, a Mallinckrodt Company. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04134143, a Phase 1 study, was terminated before completion, sponsored by Stratatech, a Mallinckrodt Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Some people with diabetes get foot ulcers that do not heal. These ulcers can get infected and cause other medical problems. Five patients with these foot ulcers volunteered to participate in the first part of this study (C9T12015, NCT02657876). They are called Cohort 1 in this registration. Cohort 1 received one application (piece) of an experimental skin tissue to make sure it was safe. This study will extend the safety test of the experimental skin tissue. It will find out if it is safe to use more than once to cover non-healing ulcers. This extension will include two more groups, Cohort 2 and Cohort 3. Cohort 2 may get up to 5 applications. Cohort 3 may get up to 10 applications. The number of applications will depend on how well the wound is healing. Participants will be in the study up to one year.
Primary Outcome
Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events
Interventions
- BIOLOGICAL ExpressGraft-C9T1 Skin Tissue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2019-11-07 |
| Est. Completion | 2020-12-30 |
| Phase | Phase 1 |
Why NCT04134143 stopped before completion
NCT04134143 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which ExpressGraft-C9T1 Skin Tissue is the first listed.
NCT04134143 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04134143 about?
NCT04134143 is a clinical study titled "Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers". Some people with diabetes get foot ulcers that do not heal. These ulcers can get infected and cause other medical problems. Five patients with these foot ulcers volunteered to participate in the first part of this study (C9T12015, NCT02657876). They are called Cohort 1 in this registration. Cohort ...
What is the current status of trial NCT04134143?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2019-11-07. Estimated completion is 2020-12-30.
What interventions are being tested in trial NCT04134143?
The interventions under investigation include: ExpressGraft-C9T1 Skin Tissue (BIOLOGICAL).
Who is sponsoring clinical trial NCT04134143?
This trial is sponsored by Stratatech, a Mallinckrodt Company, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04134143's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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