Using customized silicone orthoses to improve foot health in people with diabetic neuropathy
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
This study is testing if custom silicone foot supports can help people with diabetic neuropathy improve their foot health and quality of life over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, SP) |
| Trial ID | NCT05683106 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of customized silicone digital orthoses over six months for individuals with diabetic neuropathy. It focuses on assessing plantar pressure distribution, reduction of pre-ulcerative lesions and ulcers, and overall foot health and functionality. Participants will be randomly assigned to either an intervention or control group, with evaluations conducted at baseline, 3 months, and 6 months. The study aims to demonstrate improvements in quality of life and foot health through the use of these orthoses.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with type 1 or 2 diabetes who have diabetic peripheral neuropathy and forefoot deformities.
Not a fit: Patients with active ulcers, major amputations, or other significant neurological or vascular complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of foot ulcers and improve the quality of life for patients with diabetic neuropathy.
How similar studies have performed: While similar approaches have been explored, this specific use of customized silicone orthoses in diabetic neuropathy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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; 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.
Where this trial is running
São Paulo, SP
- Stay Care Clinica — São Paulo, Sp, Brazil (Recruiting)
Study contacts
- Principal investigator: Isabel C Sacco, PhD — Associate Professor at São Paulo University
- Study coordinator: Isabel C Sacco, PhD
- Email: icnsacco@usp.br
- Phone: +551130918426
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.