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Recruiting NCT05639478

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

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Plain-language summary for patients

Trial Parameters

Condition Diabetes; Neuropathy, Polyneuropathy (Manifestation)
Sponsor University of Sao Paulo General Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 356
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-03-01
Completion 2026-06-30
Interventions
Foot-related exercises

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Brief 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.

Eligibility Criteria

Inclusion Criteria: * Adults of both sexes; * Diabetes mellitus type 1 or 2; * Residence within the catchment area of the Family Health Units. * Availability to participate in the intervention at the established group time. Non-inclusion Criteria: * Clinical diagnosis of dementia; * Inability to provide reliable and consistent information; * Perform physiotherapy intervention throughout the intervention period; * Active foot ulcer or major vascular complications.

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