Background: Diabetic neuropathy is a condition that can be early diagnosed in DM type 2 patients.
Purpose: Evaluate the influence of customized insoles in the plantar pressure of diabetic neuropathy patients when compared to the sham group at baseline and after three and six months.
Methods: REBEC (Clinical Trial Brazilian Register) (http://www.ensaiosclinicos.gov.br/) RBR-5NQK4K, is a randomized, controlled, double-blinded clinical trial was carried out with a 46-volunteer sample in which participants were randomized to be directed to the intervention and control groups. This study was developed following the standards set for randomized clinical trials (CONSORT). The primary outcome was the analysis of plantar pressure points on the diabetic neuropathy patients' feet using podobarography in the intervention and control group patients. The secondary outcome was the foot functionality in activities of daily living assessed using the FAAM questionnaire in a 6-month follow-up period.
Results: No significant differences were found between the groups regarding the primary and secondary outcomes in the 3rd or in the 6th month.
Conclusion: Is not possible to state that insoles provided patients with a significant improvement of the footstep structure in the intervention group in comparison to the control group in diabetic neuropathy patients.
Keywords: Diabetic neuropathies; Dynamic orthoses; Plantar callosity.
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