A randomized clinical trial

Funding: The authors thank Marisa Almeida, Susana Costa, Rui Lourenco¸ and Sara Zorrinha from ACES Central − Primary Health Care Centers for the precious collaboration in the field work. We would like to deeply thank the collaborating of the following companies: Instituto Sao Joao de Deus, OKM ~ − Química Ortopedica, Lola − J. Andrade Ferreira Neves, Sensor Medica and Pierre Fabre Por- tugal. This work was supported by the CENIE (International centre on Ageing) [grant number 0348_CIE_6_E]. Aims: Determine the effectiveness of custom-made orthopedic footwear (OF) and total contact plantar orthoses (PO) on the quality of life (QoL) and functionality of people with type 2 diabetes with diabetic peripheral neuropathic (DPN). Methods: Randomized clinical study with 2 parallel intervention groups and pre- and post-test analysis. In the standard footwear group (SFg), PO and education on foot self-care were applied and in the orthopedic footwear group (OFg) the same intervention was applied, but with personalized OF. A total of 43 type 2 diabetic patients with DPN aged 61 – 76 years were randomized: 20 in to SFg and 23 to OFg. Michigan Neuropathy Screening Instrument (MNSI) was used to screen for DPN. QoL was assessed with Short Form–36 and functional level was evaluated by Lower Extremity Functional Scale (LEFS), 6 physical tests and center of pressure (CoP) oscillation. Results: No differences in QoL were found between groups. OFg showed a better functional reach and mediolateral displacement of CoP (p ≤ 0.05). Conclusions: The OF does not show evidence on functional and QoL improvement in low-risk type 2 diabetic patients with neuropathy but both groups improved significantly in functional tests. The PO showed clinical value in these patients, so a regular and specialized treatment with appropriate footwear and plantar orthoses can play an important role in reducing the complications of diabetic neuropathy. publishersversion published