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Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy
Sponsor: University of Sao Paulo General Hospital
Summary
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.
Official title: Effects of the Use of Customized Silicone Digital Orthoses on Pre-ulcerative Lesions and Plantar Pressure During Walking in People With Diabetic Neuropathy: a Randomized Controlled Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-09-06
Completion Date
2027-03-01
Last Updated
2025-03-28
Healthy Volunteers
No
Conditions
Interventions
Custom silicone digital orthosis (CSDO)
Custom silicone digital orthosis (CSDO) will be made under mold to provide realignment of toes, protection or replacement of a segment that was amputated.They will be indicated for corrections of rigid/fixed or flexible toes deformities.CSDO will be constructed using different types of silicone and different hardness considering whether the deformities are rigid or flexible and,when necessary,these components of the orthoses will be merged.Intervention participants will be asked to clean the CSDO and interdigital spaces with soap and water;adequate drying of the fingers and interdigital region;always wear the CSDO with appropriate footwear and socks;keep monitoring the integrity of the CSDO and always communicate any identification of changes in the feet or CSDO.Adverse effects will be evaluated, such as:possible skin irritation; discomfort or pain;contractures;trauma due to friction.Adherence will be verified every 3 months and via telephone contact,monthly.
Locations (1)
Stay Care Clinica
São Paulo, São Paulo, Brazil