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NCT02657876 · ClinicalTrials.gov registry record · Phase 1
ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers
A Phase 1 study, sponsored by Stratatech, a Mallinckrodt Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT02657876: Completed Phase 1 study, sponsored by Stratatech, a Mallinckrodt Company.
NCT02657876 is a Phase 1 study that has completed, run by Stratatech, a Mallinckrodt Company. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02657876, a Phase 1 study, has completed, sponsored by Stratatech, a Mallinckrodt Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This study is designed as a prospective, open-label trial focused on assessing the safety and tolerability of ExpressGraft-C9T1 skin tissue in the treatment of diabetic foot ulcers (DFU). Because the focus is on safety rather than efficacy, a standard of care comparator is not included in this first-in-human study. Targeted enrollment for this study is up to 6 subjects with a confirmed diagnosis of diabetes and who have foot ulcers. Subjects will each receive a single application of ExpressGraft-C9T1 skin tissue on a single identified study DFU following a 10-14 day run-in period. Any subjects requiring additional treatment will receive protocol-defined dressings through Study Treatment Week 12 as necessary. Enrollment will occur with a minimum of one week between each subject.
Primary Outcome
Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events during the study. The safety of ExpressGraft-C9T1 skin tissue will be evaluated by adverse events through the 12 month study session.
Interventions
- BIOLOGICAL ExpressGraft-C9T1 Skin Tissue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-01-31 |
| Est. Completion | 2019-05-28 |
| Phase | Phase 1 |
What the finished NCT02657876 record still lists
NCT02657876 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which ExpressGraft-C9T1 Skin Tissue is the first listed.
NCT02657876 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02657876 about?
NCT02657876 is a clinical study titled "ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers". This study is designed as a prospective, open-label trial focused on assessing the safety and tolerability of ExpressGraft-C9T1 skin tissue in the treatment of diabetic foot ulcers (DFU). Because the focus is on safety rather than efficacy, a standard of care comparator is not included in this first...
What is the current status of trial NCT02657876?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2018-01-31. Estimated completion is 2019-05-28.
What interventions are being tested in trial NCT02657876?
The interventions under investigation include: ExpressGraft-C9T1 Skin Tissue (BIOLOGICAL).
Who is sponsoring clinical trial NCT02657876?
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 NCT02657876's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 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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