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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT02505503
Eligibility Criteria:
Inclusion Criteria:
* Aged ≥16 years with intermittent claudication due to peripheral arterial disease
* Resting ankle-brachial index ≤0.9 and/or imaging evidence of peripheral arterial disease
* Stable symptoms for at least 3 months (assessed via self-report)
* Pain-free walking distance \<250 m on 6-minute walk test
* Ambulation that is limited primarily by calf claudication on 6-minute walk test
* Able to provide written informed consent
* Able to read and speak English
Exclusion Criteria:
* Absolute contraindications to exercise testing as defined by the American College of Sports Medicine
* Critical limb ischemia
* Function is uniquely impaired, e.g. vascular amputees
* Co-morbidities that limit walking to a greater extent than intermittent claudication (e.g. severe arthritis)
* Ambulation limited by claudication in regions other than the calf
* Current or previous (within 6 months) use of shoe inserts, knee or ankle braces or customised shoes prescribed by a health professional
* Ankle/foot pathology/pain on either side
* "High-risk" foot (e.g. significant peripheral neuropathy, foot deformity, history of foot ulceration), assessed by a vascular specialist (Registrar or Consultant) or podiatrist
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT02505503
Study Brief:
Protocol Section:
NCT02505503