Foot Care and Exercises Implementation for People With Diabetes in Primary Care

24 Feb 20264 min read0 viewsINTERVENTIONAL Trial

GIST

Official title: Implementing a Contextually Appropriate Intervention Strategy in Primary Care for the Foot-ankle of People With Diabetes to Improve Clinical and Functional Status and Quality of Life 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. Conditions: Diabetes; Neuropathy, Polyneuropathy (Manifestation) Keywords: exercise therapy, diabetic foot, preventive care, foot-related exercises, musculoskeletal functions, primary health care Study type: INTERVENTIONAL Primary purpose: TREATMENT Phases: NA Enrollment: 356 (ESTIMATED) Status: RECRUITING Completion: 2026-08-31 (ESTIMATED)

Clinical Editorial

Context and study intent

This report details a hybrid implementation-effectiveness trial aimed at introducing a contextually tailored preventive strategy within primary care to address foot-ankle health in people with diabetes.

Study design and setting

The intervention consists of 12 weeks of face-to-face group foot and ankle exercises for diabetic foot, delivered in primary care settings in Limeira, São Paulo.
Implementation efforts focus on training primary care workers to execute the program, with concurrent monitoring of both process implementation and clinical outcomes.

Population and exposure

Target population includes adults with diabetes, with manifestations consistent with polyneuropathy.
An estimated 356 participants are planned for enrollment.

Outcomes and measures

Primary objectives encompass clinical status, functional status, and quality of life.
The study explicitly tracks how the intervention is implemented in real-world primary care and its associated outcomes.