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NCT02326337 · ClinicalTrials.gov registry record · NA
Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers
A NA study, sponsored by AOTI.
- Completed
- Registry status
- NA
- Development phase
- 73
- Enrollment target
NCT02326337: Completed NA study, sponsored by AOTI.
NCT02326337 is a NA study that has completed, run by AOTI. The registered enrollment target is 73 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02326337, a NA study, has completed, sponsored by AOTI.
- COMPLETED
- Registry status
- NA
- Development phase
- 73 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers. Subjects will wear a standardized off-loading device and use advanced moist wound therapy (AMWT) dressings. Following a 2 week run-in period with the standardized care and after meeting all the eligibility criteria, half the subjects will use the TWO2 device, while the other half will use a sham device.
Primary Outcome
Number of Participants with complete wound closure defined as 100% skin re-epithelialization without dressing requirements which is confirmed by 2 consecutive study visits 2 weeks apart.
Interventions
- DEVICE Placebo Device
- DEVICE TWO2 Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2014-10 |
| Est. Completion | 2018-10-25 |
| Phase | NA |
What the finished NCT02326337 record still lists
NCT02326337 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Device is the first listed.
NCT02326337 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02326337 about?
NCT02326337 is a clinical study titled "Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers". The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers. Subjects will wear a standardized off-loading device and use advanced moist wound therapy (AMWT) dressings....
What is the current status of trial NCT02326337?
This trial is currently completed. It is a NA study. The enrollment target is 73 participants. The study started on 2014-10. Estimated completion is 2018-10-25.
What interventions are being tested in trial NCT02326337?
The interventions under investigation include: Placebo Device (DEVICE), TWO2 Device (DEVICE).
Who is sponsoring clinical trial NCT02326337?
This trial is sponsored by AOTI, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02326337's enrollment target sits among peer trials
73 1089th of 2000 higher than 912 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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