Clinical Trial

FOot CAre and Exercises ImplementatioN for People With Diabetes in Primary Care

Study acronym: FOCAIN
Recruiting
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Summary
The main objective of this type 2 hybrid implementation effectiveness trial is to implement a contextually appropriate preventive intervention for 12 weeks face to face group foot and ankle exercises for people with diabetic foot in the primary care of the city of Limeira/SP, through the training of Primary Care workers. The study will monitor the implementation itself and the clinical outcomes: clinical and functional status and quality of life.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-06-30 -> 2026-08-30 2026-08-13
minor Completion pushed: 2026-08-31 -> 2026-12-31 2026-08-13
Trial Details
NCT Number NCT05639478
Lead Sponsor University of Sao Paulo General Hospital
Conditions Diabetes; Neuropathy, Polyneuropathy (Manifestation)
Enrollment 356 participants
Start Date 2023-03-01
Primary Completion 2026-08-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-12