Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy (NCT05683106) | Clinical Trial Compass
CompletedNot Applicable
Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy
Brazil60 participantsStarted 2023-09-06
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline Pre-ulcerative lesions and ulcers at 12 and 24 weeks