Leg Thermotherapy for Intermittent Claudication
Completed · Not applicable
Conditions studied: Peripheral Artery Disease
In brief
This study proposes to evaluate the potential of leg thermotherapy as a non-pharmacological intervention that could improve the mobility and exercise tolerance of patients with intermittent claudication. Thermotherapy is a simple, easily applicable therapy that enhances exercise tolerance in patients with chronic heart failure by improving peripheral vascular endothelial function.
Key facts
- Study ID
- NCT02770547
- Run by
- Indiana University
- People needed
- 32
- Starts
- 2016-05-30
- Expected to finish
- 2018-12-14
- Last updated by the study team
- 2020-02-10
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men and women with a stable symptomatic claudication for ≥6 months
- Ankle brachial index <0.9
You may not qualify if…
- Uncontrolled Diabetes (HbA1C > 8.5 measured within 3 months prior to date of consent)
- Heart Failure
- Chronic Obstructive Pulmonary Disease
- Critical limb ischemia (ischemic rest pain or ischemia-related non healing wounds or tissue loss
- Prior amputation
- Exercise-limiting comorbidity (i.e., angina, chronic lung disease, or arthritis)
- 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 cancer
- Chronic kidney disease (eGFR <30 by Modification of Diet in Renal Disease or Mayo or Cockcroft-Gault formula).
- HIV positive, active hepatitis B virus (HBV) or hepatitis C virus (HCV) disease.
- Presence of any clinical condition that in the opinion of the principal investigator makes the patient not suitable to participate in the trial.
- Peripheral neuropathy, numbness, or paresthesia in the legs.
- Morbid obesity BMI > 35.
- Open wounds or ulcers on the extremity.
- MRI Exclusions:
- Cardiac pacemaker
- Implanted cardiac defibrillator
- Aneurysm clips
- Carotid artery vascular clamp
- Neurostimulator
- Insulin or infusion pump
- Implanted drug infusion device
- Bone growth/fusion stimulator
- Cochlear, otologic, or ear implant
Where it is running
- Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States
- Richard L. Roudebush VA Medical Center — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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