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NCT02356757 · ClinicalTrials.gov registry record · NA
Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 406
- Enrollment target
NCT02356757: Completed NA study, sponsored by VA Office of Research and Development.
NCT02356757 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 406 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02356757, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 406 participants
- Enrollment target
Study Summary
The PATRIOT study will evaluate a risk-based personalized behavioral intervention to improve foot self-care, self-monitoring, and modifiable risks for amputation such as blood glucose, blood pressure and cholesterol in order to prevent diabetic foot ulcers in patients at higher than normal risk for amputation. This novel intervention aims to improve self-care and early detection of foot abnormalities in at-risk patients with diabetes and poor foot self-care using advanced behavioral approaches to target adherence to multiple health behaviors, including foot self-care, self-monitoring, medication adherence, dietary adherence, and physical activity simultaneously. If this promising behavioral theory-driven approach delivered using common technology (phone) to the patient at home can work in a setting where improvements in foot care are so urgent, it will be an important scientific contribution.
Primary Outcome
High-resolution standard view digital photographs of the feet and footwear will be obtained and reviewed by the investigators blinded to group assignment, and a suspected ulcer or nonulcerative plantar lesion below the malleoli will be referred to a blinded (as to group assignment) adjudicators, all clinical experts. Lesions will be judged as absent/nonulcerative lesion/ulcer
Interventions
- BEHAVIORAL Personalized Behavioral Intervention
- BEHAVIORAL Current Best Practice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2015-08-24 |
| Est. Completion | 2021-09-30 |
| Phase | NA |
What the finished NCT02356757 record still lists
NCT02356757 is an interventional study that assigns participants to a tested intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Personalized Behavioral Intervention is the first listed.
NCT02356757 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02356757 about?
NCT02356757 is a clinical study titled "Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy". The PATRIOT study will evaluate a risk-based personalized behavioral intervention to improve foot self-care, self-monitoring, and modifiable risks for amputation such as blood glucose, blood pressure and cholesterol in order to prevent diabetic foot ulcers in patients at higher than normal risk for ...
What is the current status of trial NCT02356757?
This trial is currently completed. It is a NA study. The enrollment target is 406 participants. The study started on 2015-08-24. Estimated completion is 2021-09-30.
What interventions are being tested in trial NCT02356757?
The interventions under investigation include: Personalized Behavioral Intervention (BEHAVIORAL), Current Best Practice (BEHAVIORAL).
Who is sponsoring clinical trial NCT02356757?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02356757's enrollment target sits among peer trials
406 243rd of 2000 higher than 1,758 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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