Status:
COMPLETED
Heat Therapy to Reduce Pain and Improve Walking Tolerance
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Roseguini, Bruno, PhD
Michael Emery, MD
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
Phase:
NA
Brief Summary
The purpose of this study is to investigate whether exposure to heat therapy improves calf muscle oxygenation and enhances walking tolerance in patients with symptomatic Peripheral Arterial Disease (P...
Detailed Description
Heat therapy (HT) is an emerging non-invasive approach that has been shown to enhance vascular function of the leg in old individuals. The objective of this study is to establish evidence to support t...
Eligibility Criteria
Inclusion
- Men and women with stable symptomatic leg claudication for 6 months or longer.
- Ankle brachial index \< 0.9
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2019
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03435835
Start Date
August 1 2018
End Date
August 14 2019
Last Update
August 30 2022
Active Locations (1)
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1
Indiana University
Indianapolis, Indiana, United States, 46202