Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 6, 2023

Primary Completion Date

March 1, 2026

Study Completion Date

March 1, 2027

Conditions
Diabetic Neuropathies
Interventions
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.

Trial Locations (1)

02945070

RECRUITING

Stay Care Clinica, São Paulo

All Listed Sponsors
collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

lead

University of Sao Paulo General Hospital

OTHER