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NCT02356848 · ClinicalTrials.gov registry record · NA
STEP UP to Avert Amputation in Diabetes
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 241
- Enrollment target
NCT02356848: Completed NA study, sponsored by VA Office of Research and Development.
NCT02356848 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 241 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02356848, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 241 participants
- Enrollment target
Study Summary
This study will evaluate a comprehensive tailored behavioral intervention aimed to improve foot self-care and self-monitoring (combined with dermal thermometry) to prevent recurrent ulcers in Veterans at highest risk of amputation. This intervention may be a novel strategy for improving self-care and early detection of foot abnormalities in this at-risk population using psychological theories to target multiple health behaviors simultaneously. This could be an efficient and cost-effective approach to improve diabetes-related foot health behavior, and other risk factors in patients who are vulnerable to devastating consequences related to amputation.
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 panel of three blinded (as to group assignment) adjudicators, all clinical experts. Lesions will be judged as absent/nonulcerative lesion/ulcer; involving/not involving the plantar surface (defined as involving the weight-bearing surface of the foot)
Interventions
- BEHAVIORAL Tailored Intervention (TI)
- BEHAVIORAL Current Practice (CP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2015-09-03 |
| Est. Completion | 2021-09-30 |
| Phase | NA |
What the finished NCT02356848 record still lists
NCT02356848 is an interventional study that assigns participants to a tested intervention. The registered 241 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 (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Tailored Intervention (TI) is the first listed.
NCT02356848 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02356848 about?
NCT02356848 is a clinical study titled "STEP UP to Avert Amputation in Diabetes". This study will evaluate a comprehensive tailored behavioral intervention aimed to improve foot self-care and self-monitoring (combined with dermal thermometry) to prevent recurrent ulcers in Veterans at highest risk of amputation. This intervention may be a novel strategy for improving self-care an...
What is the current status of trial NCT02356848?
This trial is currently completed. It is a NA study. The enrollment target is 241 participants. The study started on 2015-09-03. Estimated completion is 2021-09-30.
What interventions are being tested in trial NCT02356848?
The interventions under investigation include: Tailored Intervention (TI) (BEHAVIORAL), Current Practice (CP) (BEHAVIORAL).
Who is sponsoring clinical trial NCT02356848?
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 NCT02356848's enrollment target sits among peer trials
241 440th of 2000 higher than 1,561 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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