Acute effects of leg heating on skeletal muscle blood flow in patients with symptomatic peripheral artery disease
Investigation of Heat Application on Leg Circulation
Brief description of study.
The purpose of this study it to determine to what extent the application of heat to the lower limbs affects circulation in the muscles of the lower leg.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: peripheral artery disease
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria:
Men and women with stable symptomatic claudication for ≥6 months
Ankle brachial index <0.9
Exclusion Criteria:
Uncontrolled Diabetes (HbA1C > 8.5 measured within 3 months prior to date of consent)
Critical limb ischemia (ischemic rest pain or ischemia-related non healing wounds or tissue loss)
Prior amputation
Recent (<3 months) infrainguinal revascularization (surgery or endovascular revascularization) or revascularization planned during study period.
Plans to change medical therapy during the duration of the study
Active treatment for cancer
Chronic kidney disease (eGFR <30 by MDRD or Mayo or Cockcroft-Gault formula).
HIV positive, active HBV or HCV disease.
Presence of any 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 potential
This study investigates how applying heat to the lower limbs affects blood flow in the muscles of the lower leg. Claudication is a condition that causes pain and cramping in the legs due to poor blood flow. This study aims to understand if heat can improve circulation in individuals with this condition.
Participants will undergo procedures that involve the application of heat to their lower limbs. The study will measure changes in blood flow and circulation to evaluate the effects of heat treatment. Participants will need to wear special pants that circulate warm water to apply heat to their legs.
- Who can participate: Men and women with stable symptomatic claudication for at least 6 months and an ankle brachial index of less than 0.9 can participate. Those with uncontrolled diabetes, critical limb ischemia, or recent revascularization are excluded.
- Study details: Participants will wear water-circulating pants that apply heat to their lower limbs. The study will monitor changes in circulation and blood flow.
Interested in the study?
Select a study center that’s convenient for you, and get in touch with the study team.
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