Eligibility Module

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: 2025-12-25 @ 2:02 AM
Ignite Modification Date: 2025-12-25 @ 2:02 AM
NCT ID: NCT01231360
Eligibility Criteria: Inclusion Criteria: * claudication symptoms * ABI ≤ 0.9 in the symptomatic leg Exclusion Criteria: * diabetes * impaired fasting glucose * peripheral vascular intervention within the prior six months * recent unstable angina * myocardial infarction or stroke within the prior six months * changes to their HMG-CoA reductase inhibitor (statin)within the past three months * changes to pentoxifylline and/or cilostazol regimen within the past three months or anticipated to be necessary during the study * are on Coumadin * exercise limitations for reasons other than intermittent claudication (such as congestive heart failure, angina, chronic lung disease, or other disorders affecting the limb such as arthritis or neuropathy) * rest pain or ulcers due to critical limb ischemia * lower extremity amputation
Healthy Volunteers: True
Sex: ALL
Minimum Age: 40 Years
Study: NCT01231360
Study Brief:
Protocol Section: NCT01231360