Status:
COMPLETED
Home-based Leg Heat Therapy
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Roseguini, Bruno, PhD
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
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 vasc...
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 randomized, controlled study is to evaluate...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03763331
Start Date
January 14 2019
End Date
June 21 2021
Last Update
March 1 2023
Active Locations (1)
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1
IU Heath Methodist
Indianapolis, Indiana, United States, 46202