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NCT02356848: STEP UP
STEP UP to Avert Amputation in Diabetes
NA trial testing Tailored Intervention (TI) in Diabetes in 241 participants. Completed in 30 September 2021.
30 June 2021
Quick facts
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 241 |
| Start date | 3 September 2015 |
| Primary completion | 30 June 2021 |
| Estimated completion | 30 September 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Tailored Intervention (TI)
- Current Practice (CP)
Conditions studied
- Diabetes — all drugs for Diabetes →
- Foot Ulcer — all drugs for Foot Ulcer →
Sponsor
VA Office of Research and Development — full company profile →
Who can join
21 and older, any sex, with Diabetes or Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Navigating COVID-19 and related challenges to completing clinical trials: Lessons from the PATRIOT and STEP-UP randomized prevention trials.
Salovaara PK, Li C, Nicholson A, Lipsitz SR, et al · · 2023 · cited 1× · PMID 36562090 · DOI 10.1177/17407745221140041
Verify or expand the search:
- PubMed search for NCT02356848
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other VA Office of Research and Development trials
Trials by the same sponsor.
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- NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans · NA · not yet recruiting
- NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02356848 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
- Last refreshed: 8 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02356848.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing