Home-based Leg Heat Therapy

Completed · Not applicable · Has a placebo group

Conditions studied: Peripheral Arterial Disease

In brief

The objective of this study is to evaluate the benefits of participating for 8 weeks in a home-based daily treatment with heat therapy (HT) or a thermoneutral control intervention, as assessed by vascular function, walking tolerance and quality of life.

Key facts

Study ID

NCT03763331

Run by

Indiana University

People needed

34

Starts

2019-01-14

Expected to finish

2021-06-21

Last updated by the study team

2023-03-01

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women with a stable symptomatic PAD for ≥6 months
• Ankle brachial index <0.9 in at least one leg
• Age between 40 and 80 years

You may not qualify if…

• Uncontrolled Diabetes (HbA1C > 8.5 measured within 3 months prior to date of consent)
• Wheelchair bound
• Use of a walking aid (i.e. cane, crutches, walker, motorized chair)
• Critical limb ischemia (ischemic rest pain or ischemia-related non healing wounds or tissue loss
• Impaired thermal sensation in the legs
• Exercise-limiting comorbidity
• Chronic Heart Failure stages C and stage D (Stage C: structural heart disease is present and symptoms have occurred; Stage D: presence of advanced heart disease with continued heart failure symptoms requiring aggressive medical therapy)
• Morbid obesity BMI > 35 or unable to fit into water-circulating pants
• Open wounds or ulcers on the extremity
• Prior amputation
• Lower extremity revascularization, major orthopedic surgery, cardiovascular event, or coronary revascularization in the previous three months
• Planned revascularization or major surgery during the next six months
• 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.
• Unable to walk on the treadmill

Where it is running

• IU Heath Methodist — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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