Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy

NCT05683106 | Completed DMC

• 1 other identifier: LaBiMPH03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetes Mellitus; Diabetic foot; Plantar pressure; Orthosis digital; quality of life

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Pre-ulcerative lesions and ulcers at 12 and 24 weeks

  It will be evaluated according to a study, which classifies hyperkeratosis into 6 degrees

  12 and 24 weeks

Secondary Outcomes (7)

• Change from Baseline Dynamic Plantar Pressure Distribution during gait at 12 and 24 weeks

  12 and 24 weeks

• Change from Baseline Foot health and functionality at 12 and 24 weeks

  12 and 24 weeks

• Change from baseline of the Quality of life at 12 and 24 weeks

  12 and 24 weeks

• Change from Baseline Safety at 12 and 24 weeks

  12 and 24 weeks

• Change from Baseline Comfort at 12 and 24 weeks

  12 and 24 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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)

Control Group

NO INTERVENTION

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.

Interventions

Custom silicone digital orthosis (CSDO) DEVICE

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Stay Care Clinica

São Paulo, São Paulo, 02945070, Brazil

Location

Related Publications (1)

• Lucoveis MLS, Gamba M, Silva EQ, Pinto LAS, Sacco ICN. The effects of the use of customized silicone digital orthoses on pre-ulcerative lesions and plantar pressure during walking in people with diabetic neuropathy: A study protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2023 Dec 23;37:101247. doi: 10.1016/j.conctc.2023.101247. eCollection 2024 Feb.

  PMID: 38269045 DERIVED

Related Links

• University of Sao Paulo website
• Laboratory of Biomechanics of Human Movement and Posture website

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus; Diabetic Foot

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Isabel C Sacco, PhD

  Associate Professor at São Paulo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Assignment

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 12, 2023
• Study Start: September 6, 2023
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)