Peripheral Artery Disease Clinical Trial
Official title:
Leg Thermotherapy for Intermittent Claudication
Verified date | January 2020 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | December 14, 2018 |
Est. primary completion date | December 14, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Men and women with a stable symptomatic claudication for =6 months - Ankle brachial index <0.9 Exclusion Criteria: - 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 - History of claustrophobia or who are unable to lie flat or who do not fit inside the bore of the scanner |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University Health Methodist Hospital | Indianapolis | Indiana |
United States | Richard L. Roudebush VA Medical Center | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | American Heart Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes | 6-minutes walk test | Maximal walking distances on a 6mwt were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values. | |
Primary | Blood Pressure | Participants have systolic, diastolic and mean blood pressure recording 14 times during baseline, week 3 and week 6 experimental sessions. | Average blood pressure taken every 5 minutes for 70 minutes was obtained at weeks 3/6 and 6/6 of the study and compared to baseline values. | |
Primary | Circulating Levels of Endothelin-1 (pg/mL) | Blood draw | Serum endothelin-1 levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values. | |
Primary | Circulating Total Nitrate Levels (mmol) | Blood Draw | Serum total nitrate levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values. | |
Secondary | Vascular Function Assessed by Leg MRI to Measure Peak Blood Flow in Popliteal Artery (ml/s) | Phase contrast magnetic resonance imaging was performed on the leg that the patient indicated to have the most severe claudication. An inflation cuff was placed around the thigh and inflated to 75 mmHg above resting brachial systolic pressure for 5 minutes. After 5 minutes of inflation, the cuff was release and an additional 10 minutes of imaging took place. | Peak flows after post-occlusive reactive hyperemia were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values. | |
Secondary | Vascular Function Measured by Ankle-brachial Index - Calculated by Dividing Higher of Posterior Tibial or Dorsalis Pedis Blood Pressure (mmHg) by Higher of Right or Left Arm Systolic Blood Pressure (mmHg) | Ankle-brachial Index | Ankle-brachial index measures were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values. | |
Secondary | Vascular Function Measuring Leg Cutaneous Vascular Conductance - Measured by Laser-doppler Flowmetry of the Skin | Laser-Doppler flowmetry of skin included placement of two heating probes on the anterior portion of the lower leg. The participant sat in a semi-recumbent position for 70 minutes while the temperature of the probe progressed from 33C to 39C at minute 10 and then to 43C at minute 50. Cutaneous vascular conductance was calculated at the average red blood cell flux during the final 2 minutes of the 39C heating portion divided by the mean arterial pressure taken at that time. | Maximal cutaneous vascular conductance values after 40 minutes of localized heating were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values. | |
Secondary | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | 36-item Short Form Health Survey. All scales are scored 1-100, with 1 being the poorest rating and 100 being the most optimal. | SF-36 questionnaires were administered at weeks 3/6 and 6/6 of the study and compared to baseline values. |
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