Efficacy of customized insoles in the improvement of plantar pressure in patients with diabetic neuropathy: Protocol of a randomized and controlled clinical trial

OBJECTIVE: To evaluate the influence of customized insoles in the plantar pressure of diabetes patients with neuropathy in comparison to the sham group. METHODS:  The work method, duly registered at the Registro Brasileiro de Ensaios Clínicos – REBEC (Clinical Trial Brazilian Register) (http://www.ensaiosclinicos.gov.br/) RBR-5NQK4K, includes a randomized, controlled, prospective, double-blinded clinical trial, with a sample of 46 volunteers that will be randomly randomized in a 1: 1 ratio to be referred to intervention and control groups. The intervention group will receive customized insoles, with a retrocapital bar and an ethyl vinyl acetate plaque (EVA) in the same shape as the retrocapital bar, in order to reduce the pressure on the forefoot. In the control group, flat insoles will be prepared without any therapeutic objective. This project was developed according to the standard protocol for randomized clinical trials (SPIRIT). Along with the clinical evaluation, demographic data of the sample will be collected to identify and confirm the presence of peripheral neuropathy, next, the pedobarographic will be evaluated, and finally, the patients will answer the FAAM questionnaire to assess foot functionality. The primary outcome will be analyzing pressure points in KiloPascal (kPa) in the patients’ feet through pedobarographic of the patients in the intervention and control groups. The secondary outcome will be the foot functionality in activities of daily living through the FAAM (Foot and Ankle Ability Measure), considering the volunteers in the initial evaluation, third and sixth months.  FINAL CONSIDERATIONS: Mainly, results of this study will show whether there is a structural alteration in the analysis of the plantar pressure due to the continuous use of insoles and present the evaluation of whether the use of therapeutic insoles improves the foot functionality of the same users when compared to sham insoles.