Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT05683106
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;
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05683106
Study Brief:
Protocol Section:
NCT05683106