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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT02380794
Eligibility Criteria:
Inclusion Criteria:
1. Men and women 40 years or older
2. With stable intermittent claudication secondary to PAD defined as resting ABI \<0.90 and a ≥10mmHg decrease in ankle artery blood pressure after exercise.
3. No change in existing therapy for claudication within 3 months of study enrollment.
Exclusion Criteria:
1. Critical limb ischemia defined by ischemic rest pain, ulceration, or gangrene
2. Major lower limb amputation
3. Surgical or endovascular revascularization for PAD within 3 months prior to enrolment
4. Exercise limitation due to significant concomitant disease (e.g. severe arthritis, cardiac or pulmonary disease)
5. Pregnant women and women who are breastfeeding
6. Patients who are currently on Warfarin
7. Patients with resting systolic blood pressure below 100mmHg (SBP \< 100mmHg)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02380794
Study Brief:
Protocol Section:
NCT02380794