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 @ 12:02 PM
Ignite Modification Date:
2025-12-24 @ 12:02 PM
NCT ID:
NCT02472561
Eligibility Criteria:
Inclusion Criteria:
* Adequate clinical stability has been achieved in the judgment of the investigator to allow participation in study assessments and the intervention
* A history of stable intermittent claudication for \>2 months, and an ABI \<0.9 at rest
* No contraindications to exercise training
* All subjects will be on the recommended regimen of statin and antiplatelet therapy
* Signed informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study
Exclusion Criteria:
* Present or a past history of gangrene, impending limb loss or osteomyelitis
* Severe peripheral neuropathy
* Any condition other than PAD that limits walking for example arthritis or chronic obstructive pulmonary disease (COPD)
* Unstable angina, history of significant left main disease or three vessel coronary artery disease (\>70% stenosis, unprotected by grafts) or recent myocardial infarction (less than eight weeks)
* Chest pain during treadmill exercise which appears before the onset of claudication, or 2 mm ST depression during exercise regardless of the results of tests for myocardial ischemia
* Refusal or inability to give informed consent or inability or unwillingness to comply with the study requirements.
* Dementia that precludes ability to participate in and follow study protocols
* Enrollment in a clinical trial not approved for co-enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02472561
Study Brief:
Protocol Section:
NCT02472561