Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy
Diabetic Neuropathies
About this trial
This is an interventional prevention trial for Diabetic Neuropathies focused on measuring Diabetes Mellitus, Diabetic foot, Plantar pressure, Orthosis digital, quality of life
Eligibility Criteria
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)
Sites / Locations
- Stay Care ClinicaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention Group
Control Group
The participants will receive a custom silicone digital orthosis (CSDO) to realign the toes according to their needs. They will be instructed to use the CSDO throughout the day, remove it to sleep and reposition it on the foot the next day. Furthermore they will be assisted by a stomatherapy specialist, dermatology or clinical podiatry nurse and will receive foot care for thinning the calluses, referral (if necessary) to the Specialized Rehabilitation Center - CER, health equipment linked to SUS, for the purchase of insoles and/ or molded footwear (when indicated) and guidance on the use of therapeutic footwear.
The participants will be assisted by the stomatherapy specialist, dermatology or clinical podiatry nurse and will receive foot care for thinning the calluses, referral (if necessary) to the Specialized Rehabilitation Center - CER, health equipment linked to SUS, for the purchase of insoles and/ or molded footwear (when indicated) and guidance on the use of therapeutic footwear.