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

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Sex

ALL

See this in plain English?

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