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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT03435835
Eligibility Criteria:
Inclusion Criteria:
* Men and women with stable symptomatic leg claudication for 6 months or longer.
* Ankle brachial index \< 0.9
Exclusion Criteria:
* Heart Failure
* COPD
* Critical limb ischemia
* Prior amputation
* Exercise-limiting co-morbidity
* Recent infrainguinal revascularization or planned during study period
* Plans to change medical therapy during duration of the study
* Active cancer
* Chronic kidney disease
* HIV positive, active HBV or HCV disease
* Presence of any unsuitable comorbid clinical condition in the opinion of the PI
* Peripheral neuropathy, numbness or paresthesia in the legs
* Morbid obesity, BMI \> 36 or unable to fit in water-circulating pants
* Open wounds or ulcers on the extremity
* Unable to walk on the treadmill
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03435835
Study Brief:
Protocol Section:
NCT03435835