Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy

April 27, 2026 updated by: Isabel de Camargo Neves Sacco, University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, (6) Metatarsophalangeal joint range of motion (ROM).

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 02945070
        • Stay Care Clinica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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;

Exclusion Criteria:

  • Presence of other diagnosed neurological diseases;
  • Presence of dementia or inability to give consistent information;
  • Presence of major vascular complications;
  • Receiving any physiotherapy intervention;
  • Major vascular complications (ischemia)
  • Presence of an active ulcer at the time of baseline assessment;
  • Major amputations;
  • Minor amputations, except toes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention 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.
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.
No Intervention: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Pre-ulcerative lesions and ulcers at 12 and 24 weeks
Time Frame: 12 and 24 weeks
It will be evaluated according to a study, which classifies hyperkeratosis into 6 degrees
12 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Foot health and functionality at 12 and 24 weeks
Time Frame: 12 and 24 weeks
The Brazilian version of the Foot-Health Status Questionnaire (FHSQ-BR) will be used. This instrument is divided into three domains and we are using domains I and II. The first domain evaluates the foot in four spheres: pain, function, footwear and general health. The second domain evaluates the general state of health, also in four spheres: general health, physical activity, social capacity and vitality. Domains I and II are composed of questions with answer choices that are presented in the affirmative sentences and corresponding numbers. Domain III, which is not being used, comprises the collection of general demographic data of individuals. Each domain receives a score from 0 to 100, where 100 expresses the best condition and 0 to worst.
12 and 24 weeks
Change from baseline of the Quality of life at 12 and 24 weeks
Time Frame: 12 and 24 weeks
Participants will answer the EQ-5D questionnaire, which is an instrument for measuring health-related quality of life that allows generating an index representing the value of an individual's health status.
12 and 24 weeks
Change from Baseline Dynamic Plantar Pressure Distribution during gait at 12 and 24 weeks
Time Frame: 12 and 24 weeks
A pressure platform (emed®-q100, novel, Germany) will be used to assess peak pressure (kPa) in the forefoot region during walking.
12 and 24 weeks
Change from Baseline Safety at 12 and 24 weeks
Time Frame: 12 and 24 weeks
To assess safety with the use of orthoses, a closed structured questionnaires will be applied, consisting of 11 questions related to safety. Responses will be evaluated using a 5-point Likert scale (1 = strongly agree; 2 = agree; 3 = neither agree nor disagree; 4 = disagree; 5 = strongly disagree).
12 and 24 weeks
Change from Baseline Comfort at 12 and 24 weeks
Time Frame: 12 and 24 weeks
To assess comfort with the use of orthoses, a Visual Analogue Scale (VAS) will be applied, consisting of 0 and 10 marked points, in which 0 indicates no discomfort and 10 indicates the highest level of discomfort.
12 and 24 weeks
Change from Baseline Satisfaction at 12 and 24 weeks
Time Frame: 12 and 24 weeks
To assess satisfaction with the use of orthoses, a closed structured questionnaires will be applied, consisting of 7 related to satisfaction. Responses will be evaluated using a 5-point Likert scale (1 = strongly agree; 2 = agree; 3 = neither agree nor disagree; 4 = disagree; 5 = strongly disagree).
12 and 24 weeks
Range of motion (ROM) of the metatarsophalangeal joint at 12 and 24 weeks
Time Frame: 12 and 24 weeks
To assess active range of motion (ROM) of the metatarsophalangeal joint, a manual goniometer will be used to measure active joint amplitude.
12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Isabel C Sacco, PhD, Associate Professor at São Paulo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2023

Primary Completion (Actual)

March 1, 2026

Study Completion (Actual)

April 1, 2026

Study Registration Dates

First Submitted

December 20, 2022

First Submitted That Met QC Criteria

January 5, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LaBiMPH03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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