search
Back to results

Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy

Primary Purpose

Diabetic Neuropathies

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Custom silicone digital orthosis (CSDO)
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Neuropathies focused on measuring Diabetes Mellitus, Diabetic foot, Plantar pressure, Orthosis digital, quality of life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; Presence of an active ulcer at the time of baseline assessment. Exclusion Criteria: Presence of other diagnosed neurological diseases; Presence of dementia or inability to give consistent information; Presence of major vascular complications; Perform physiotherapy intervention throughout the intervention period; Receiving any physiotherapy intervention; Major vascular complications (ischemia)

Sites / Locations

  • Stay Care ClinicaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline Dynamic Plantar Pressure Distribution during gait at 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.
Change from Baseline Foot health and functionality at 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.
Change from baseline of the Quality of life at 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.
Change from Baseline Safety at 12 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).
Change from Baseline Satisfaction at 12 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).
Change from Baseline Comfort at 12 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.

Full Information

First Posted
December 20, 2022
Last Updated
September 26, 2023
Sponsor
University of Sao Paulo General Hospital
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
search

1. Study Identification

Unique Protocol Identification Number
NCT05683106
Brief Title
Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2023 (Actual)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
March 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 54 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
Keywords
Diabetes Mellitus, Diabetic foot, Plantar pressure, Orthosis digital, quality of life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Single
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Custom silicone digital orthosis (CSDO)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Pre-ulcerative lesions and ulcers at 12 and 24 weeks
Description
It will be evaluated according to a study, which classifies hyperkeratosis into 6 degrees
Time Frame
12-weeks, 24-weeks
Secondary Outcome Measure Information:
Title
Change from Baseline Dynamic Plantar Pressure Distribution during gait at 12 and 24 weeks
Description
A pressure platform (emed®-q100, novel, Germany) will be used to assess peak pressure (Kpa) in the forefoot region during walking.
Time Frame
12 and 24 weeks
Title
Change from Baseline Foot health and functionality at 12 and 24 weeks
Description
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.
Time Frame
12 and 24 weeks
Title
Change from baseline of the Quality of life at 12 and 24 weeks
Description
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.
Time Frame
12 and 24 weeks
Title
Change from Baseline Safety at 12 weeks
Description
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).
Time Frame
12 weeks
Title
Change from Baseline Satisfaction at 12 weeks
Description
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).
Time Frame
12 weeks
Title
Change from Baseline Comfort at 12 weeks
Description
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.
Time Frame
12-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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; Presence of an active ulcer at the time of baseline assessment. Exclusion Criteria: Presence of other diagnosed neurological diseases; Presence of dementia or inability to give consistent information; Presence of major vascular complications; Perform physiotherapy intervention throughout the intervention period; Receiving any physiotherapy intervention; Major vascular complications (ischemia)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabel C Sacco, PhD
Phone
+551130918426
Email
icnsacco@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Maria L Lucoveis, MS
Phone
+551131594093
Email
marialucoveis@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel C Sacco, PhD
Organizational Affiliation
Associate Professor at São Paulo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stay Care Clinica
City
São Paulo
State/Province
SP
ZIP/Postal Code
02945070
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria L Lucoveis, MS
Phone
+551131584093
Email
marialucoveis@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.usp.br
Description
University of Sao Paulo website
URL
http://www.usp.br/labimph
Description
Laboratory of Biomechanics of Human Movement and Posture website

Learn more about this trial

Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy

We'll reach out to this number within 24 hrs