Status:
WITHDRAWN
Acute Effects of Leg Heating on Skeletal Muscle Blood Flow
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Roseguini, Bruno, PhD
Purdue University
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
Phase:
NA
Brief Summary
The purpose of this study is to apply local heat to the legs, thighs and buttocks of patients with peripheral arterial disease and use PET/CT imaging with an injectable stable radiotracer to study dir...
Detailed Description
Cilostazol is the only effective medication available to treat walking pain (intermittent claudication) and it has multiple side effects. Overall improvement in walking performance in patients who use...
Eligibility Criteria
Inclusion
- Men and women with a stable symptomatic claudication for \>/= 6 months
- Ankle brachial index \< 0.9
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03763357
Start Date
July 1 2022
End Date
December 31 2022
Last Update
March 28 2023
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