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Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy

NCT05683106 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-04

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Isabel C Sacco, PhD · Associate Professor at São Paulo University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-06
Primary Completion
2026-03-01
Completion
2026-04-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05683106 on ClinicalTrials.gov