Economic evaluation of an exercise program for diabetic foot care with the proposition of a care pathway in primary health care in Limeira-SP

Diabetes Mellitus constitutes one of the major contemporary public health challenges due to its high prevalence, chronic nature, and the substantial impact of its preventable complications on individuals’ functioning and the sustainability of health systems. Among these complications, Diabetic Peripheral Neuropathy stands out for its high morbidity and mortality and for the substantial costs associated with hospitalizations, amputations, and rehabilitation processes, particularly within the Brazilian Unified Health System (SUS). Although Primary Health Care is recognized as the strategic level for the prevention of these complications, significant gaps remain in the implementation of structured preventive interventions and in the generation of economic evidence to support decision-making and health planning. The aim of this study is to conduct a cost-effectiveness evaluation and a budget impact analysis of a preventive foot care intervention for people with diabetes, within the context of an implementation study, from the perspectives of the Brazilian Unified Health System and society, as well as to develop a proposed care pathway and a practical guide to support care in Primary Health Care. The economic evaluation will be conducted alongside a cluster randomized controlled trial, considering clinical, functional, and quality-of-life outcomes, including symptoms and severity of diabetic peripheral neuropathy and functional disability. The budget impact analysis will be performed from the perspective of SUS decision-makers, projecting the direct costs associated with the incorporation, dissemination, and maintenance of the intervention over a four-year time horizon. Additionally, a multidisciplinary care pathway proposal and a practical guide for the care and prevention of Diabetic Peripheral Neuropathy will be developed for the municipality of Limeira, São Paulo, Brazil. The results are expected to provide technical and economic evidence to inform health decision-making, supporting the sustainable incorporation of cost-effective preventive strategies in Primary Health Care.