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NCT05639478: FOCAIN

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

Recruiting now NA Last updated 24 February 2026
What this trial tests

NA trial testing Foot-related exercises in Diabetes; Neuropathy, Polyneuropathy (Manifestation) in 356 participants. Currently enrolling.

Timeline
1 March 2023
Primary endpoint
30 June 2026
31 August 2026

Quick facts

Lead sponsorUniversity of Sao Paulo General Hospital
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment356
Start date1 March 2023
Primary completion30 June 2026
Estimated completion31 August 2026
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

University of Sao Paulo General Hospital

Who can join

18 and older, any sex, with Diabetes; Neuropathy, Polyneuropathy (Manifestation). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Implementing a contextually appropriate foot-ankle exercise programme in primary care for the prevention of modifiable risk factors for ulcers in people with diabetes: protocol for a hybrid type 2 study.
    Rodrigues CB, Soares PNC, Schmitt ACB, Sacco ICN. · · 2024 · cited 2× · PMID 38316587 · DOI 10.1136/bmjopen-2023-078958
  2. From evidence to action: contextual determinants for the pre-implementation of a foot-ankle exercise program for diabetes in primary care.
    Soares PNC, Sacco ICN, Rodrigues CB, Santos GS, et al · · 2026 · PMID 41527130 · DOI 10.1186/s12913-025-13971-4

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Trials by the same sponsor.

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Data sources for this page

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