Last reviewed · How we verify

NCT02356848: STEP UP

STEP UP to Avert Amputation in Diabetes

Completed NA Last updated 8 October 2021
What this trial tests

NA trial testing Tailored Intervention (TI) in Diabetes in 241 participants. Completed in 30 September 2021.

Timeline
3 September 2015
Primary endpoint
30 June 2021
30 September 2021

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment241
Start date3 September 2015
Primary completion30 June 2021
Estimated completion30 September 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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:

Other recruiting trials for Diabetes

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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