NCT05683106

Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The present study aims to evaluate the effects and safety of the use of customized silicone digital orthoses for six months in the plantar pressure distribution during gait, in the reduction of pre-ulcerative lesions and plantar ulcers at forefoot, in functional balance, foot deformities, quality of life and foot health and functionality in people with diabetes and and diabetic neuropathy with risk category 2 and 3, according to the International Working Group on Diabetic Foot. The sample will consist of 60 participants, who will be randomly allocated, in a randomized controlled clinical trial, in the control or intervention groups and evaluated at baseline, 3 and 6 months of follow up. The assessment includes (1) classification of the risk of foot ulceration, (2) analysis of plantar pressure during gait, (3) quality of life, (4) foot deformities, (5) pre-ulcerative lesions, (6) functionality and general health of the feet. The hypothesis of this study is that the intervention group will present a reduction in the peak pressures during gait, a reduction in hyperkeratosis at forefoot, a reduction in the incidence and recurrence of forefoot ulcerations, and improved quality of life and in the functionality and health of the foot, when compared to the control group after six months of use of silicone digital orthoses.

Conditions

• Diabetic Neuropathies

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-09-06
• Primary completion: 2026-03-01
• Completion: 2027-03-01
• First posted: 2023-01-12
• Last updated: 2025-03-28

Locations

1 site across 1 country: Brazil