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:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT02061059
Eligibility Criteria:
Inclusion Criteria:
* diabetes
* neuropathy
* prescription of therapeutic footwear
* diabetic foot ulcer in the last 5 years
* receiving regular preventive foot care
* written informed consent
Exclusion Criteria:
* peripheral arterial disease
* not motivated to wear therapeutic footwear
* active foot ulcer
* recent vascular intervention
* severe mobility impairment
* amputation more proximal than toes, except a single ray amputation is allowed.
* severe visual impairment
* active cancer
* severe cardiac/ pulmonary failure
* severe oedema
* chronic drug abuse
* severe psychiatric illness
* hospital admission at the time of inclusion
* any condition that may interfere with follow-up visits.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02061059
Study Brief:
Protocol Section:
NCT02061059