Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy

The present study aims to evaluate the efficacy and safety of the use of customized silicone digital orthoses for six months in the distribution of plantar pressure, in the reduction of pre-ulcerative lesions and plantar ulcers in the forefoot, foot deformities, quality of life and foot health and functionality in people with diabetes and neuropathy with risk category 2 and 3 for ulcers, according to the International Working Group on Diabetic Foot.

Inclusion Criteria:Diagnosed type 1 or 2 diabetes, with diabetic peripheral neuropathy confirmed by loss of sensitivity measured by 10 g Semmes-Weinstein monofilament or 128Hz tuning fork and by the fuzzy score (www.usp.br/labimph/fuzzy);Presence of 1 or more deformities at the forefoot region (claw toes, hammer toes, mallet toes, overlapping toes, hallux valgus, prominence of the metatarsal heads or reduction/displacement of the fat pad);Ability to walk independently with or without the aid of a walking device;Presence of an active ulcer at the time of baseline assessment.Exclusion Criteria:Presence of other diagnosed neurological diseases;Presence of dementia or inability to give consistent information;Presence of major vascular complications;Perform physiotherapy intervention throughout the intervention period;Receiving any physiotherapy intervention;Major vascular complications (ischemia)