WithdrawnNot Applicable

Acute Effects of Leg Heating on Skeletal Muscle Blood Flow

Stopped: Unable to obtain CT contrast from provider

0Started 2022-07-01

Plain-language 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 direct measurement of blood flow in the legs pre and post heat treatment.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in calf blood flow

Timeframe: Blood flow measurements will be completed at baseline (0 minutes) and after 45 and 90 minutes of exposure to heat therapy or a control regimen

Trial details

NCT IDNCT03763357

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Peripheral Arterial Disease trials