Heat Therapy to Reduce Pain and Improve Walking Tolerance
Peripheral Arterial Disease
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility Criteria
Inclusion Criteria:
- Men and women with stable symptomatic leg claudication for 6 months or longer.
- Ankle brachial index < 0.9
Exclusion Criteria:
- Heart Failure
- COPD
- Critical limb ischemia
- Prior amputation
- Exercise-limiting co-morbidity
- Recent infrainguinal revascularization or planned during study period
- Plans to change medical therapy during duration of the study
- Active cancer
- Chronic kidney disease
- HIV positive, active HBV or HCV disease
- Presence of any unsuitable comorbid clinical condition in the opinion of the PI
- Peripheral neuropathy, numbness or paresthesia in the legs
- Morbid obesity, BMI > 36 or unable to fit in water-circulating pants
- Open wounds or ulcers on the extremity
- Unable to walk on the treadmill
Sites / Locations
- Indiana University
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Sham, then heat therapy
Heat therapy, then sham
Participants were fitted with liquid-circulating trousers. In the sham-treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States). At least 72 hrs after completion of the sham treatment session, participants returned to the laboratory and received the heat therapy (HT) treatment. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC.
Participants were fitted with liquid-circulating trousers. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC. At least 72 hrs after completion of the sham treatment session, participants returned to the laboratory and received the sham treatment. In the sham-treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States).