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 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT03763357
Eligibility Criteria:
Inclusion Criteria:
* Men and women with a stable symptomatic claudication for \>/= 6 months
* Ankle brachial index \< 0.9
Exclusion Criteria:
* Uncontrolled diabetes
* Heart failure
* COPD
* Critical limb ischemia
* Prior amputation
* Exercise-limiting co-morbidity
* Recent (\< 3 months) intra-inguinal revascularization or planned in study period
* Plans to change medical therapy during duration of study
* Active cancer
* Chronic kidney disease (eGFR \< 30)
* HIV positive, active HBV or HCV disease
* Presence of an clinical condition that makes the patient not suitable to participate in the trial
* Peripheral neuropathy, numbness or paresthesia in the legs
* Morbid obesity BMI \> 36 or unable to fit into water-circulating pants
* Open wounds or ulcers on the extremity
* Claustrophobia/unable to tolerate PET/CT scanning
* Women of child-bearing age
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03763357
Study Brief:
Protocol Section:
NCT03763357