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NCT01396837 · ClinicalTrials.gov registry record · Phase 2
Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
A Phase 2 study, sponsored by RedDress.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01396837: Completed Phase 2 study, sponsored by RedDress.
NCT01396837 is a Phase 2 study that has completed, run by RedDress. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01396837, a Phase 2 study, has completed, sponsored by RedDress.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety of the RedDress Wound Care System (RD1) in patients Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
Primary Outcome
Adverse event rate will be calculated including serious adverse events (SAEs), adverse events (AEs) (including any lack of venous access events), and device-related adverse events (DRAEs) (safety population and ITT populations).
Interventions
- DEVICE RedDress Wound Care System (RD1)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-05 |
| Est. Completion | 2017-03 |
| Phase | Phase 2 |
What the finished NCT01396837 record still lists
NCT01396837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which RedDress Wound Care System (RD1) is the first listed.
NCT01396837 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01396837 about?
NCT01396837 is a clinical study titled "Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.". The purpose of this study is to assess the safety of the RedDress Wound Care System (RD1) in patients Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
What is the current status of trial NCT01396837?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2014-05. Estimated completion is 2017-03.
What interventions are being tested in trial NCT01396837?
The interventions under investigation include: RedDress Wound Care System (RD1) (DEVICE).
Who is sponsoring clinical trial NCT01396837?
This trial is sponsored by RedDress, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01396837's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 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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