Peripheral Artery Disease
Conditions
Brief summary
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.
Detailed description
Peripheral arterial disease is characterized by atherosclerotic obstruction of the arteries in the lower extremities and affects approximately 10% of individuals older than 65 years. The most common clinical presentation of peripheral arterial disease is intermittent claudication, defined as leg pain caused by insufficient blood flow during walking. Individuals with intermittent claudication have severe exercise intolerance and markedly reduced levels of daily ambulatory activity. It is estimated that up to 40 million people worldwide suffer from intermittent claudication. Despite the increasing prevalence of this condition, few medical therapies improve mobility and exercise tolerance in these patients. An urgent need remains for the development of novel, non-invasive strategies that are more widely accessible and eliminate the need for supervision and frequent traveling to a clinical facility. The 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. Subjects will complete baseline assessments for eligibility and ability to do study, including medical history, quality of life assessment, ankle-brachial measurement, leg MRI, venous blood draw, assessment of vascular function, and 6-minute walk test. Treatment consists of 3 treatment sessions per week for six consecutive weeks. Subjects will be randomized to low-heat therapy or high-heat therapy. Subjects will wear water-circulating pants through which the heat therapy will be administered during the treatment sessions. Outcome measurements (same as baseline assessments) will be repeated after 9 treatment sessions and after 18 treatment sessions (at the end of the treatment period).
Interventions
DEVICELow Heat Thermotherapy
Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg.
DEVICEHigh Heat Thermotherapy
Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg.
Sponsors
American Heart Association
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Circulating Total Nitrate Levels (mmol) | Serum total nitrate levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values. | Blood Draw |
| Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes | Maximal walking distances on a 6mwt were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values. | 6-minutes walk test |
| Blood Pressure | 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. | Participants have systolic, diastolic and mean blood pressure recording 14 times during baseline, week 3 and week 6 experimental sessions. |
| Circulating Levels of Endothelin-1 (pg/mL) | Serum endothelin-1 levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values. | Blood draw |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vascular Function Assessed by Leg MRI to Measure Peak Blood Flow in Popliteal Artery (ml/s) | Peak flows after post-occlusive reactive hyperemia were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values. | 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. |
| 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 measures were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values. | Ankle-brachial Index |
| Vascular Function Measuring Leg Cutaneous Vascular Conductance - Measured by Laser-doppler Flowmetry of the Skin | 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. | 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. |
| Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | SF-36 questionnaires were administered at weeks 3/6 and 6/6 of the study and compared to baseline values. | 36-item Short Form Health Survey. All scales are scored 1-100, with 1 being the poorest rating and 100 being the most optimal. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Heat Thermotherapy Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg.
Low Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg. | 15 |
| High Heat Thermotherapy High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg.
High Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Patient non-compliant | 1 | 0 |
Baseline characteristics
| Characteristic | Low Heat Thermotherapy | High Heat Thermotherapy | Total |
|---|---|---|---|
| 6 minute walk test distance | 386.38 meters STANDARD_DEVIATION 85.08 | 414.12 meters STANDARD_DEVIATION 109.23 | 400.25 meters STANDARD_DEVIATION 97.23 |
| Age, Continuous | 69.00 years STANDARD_DEVIATION 7.8 | 68.73 years STANDARD_DEVIATION 8.99 | 68.87 years STANDARD_DEVIATION 8.27 |
| Ankle-Brachial Index | 0.64 Ratio STANDARD_DEVIATION 0.11 | 0.70 Ratio STANDARD_DEVIATION 0.11 | 0.67 Ratio STANDARD_DEVIATION 0.11 |
| BMI | 26.93 kg/m^2 STANDARD_DEVIATION 4.21 | 27.81 kg/m^2 STANDARD_DEVIATION 4.11 | 27.36 kg/m^2 STANDARD_DEVIATION 4.11 |
| Cutaneous Vascular Conductance | 51.91 Percentage of maximum conductance STANDARD_DEVIATION 4.23 | 56.33 Percentage of maximum conductance STANDARD_DEVIATION 2.78 | 54.12 Percentage of maximum conductance STANDARD_DEVIATION 2.52 |
| Diastolic Blood Pressure | 80.82 mmHg STANDARD_DEVIATION 10.37 | 82.24 mmHg STANDARD_DEVIATION 8.85 | 81.53 mmHg STANDARD_DEVIATION 9.5 |
| Height | 173.45 cm STANDARD_DEVIATION 7.09 | 175.20 cm STANDARD_DEVIATION 6.71 | 174.30 cm STANDARD_DEVIATION 6.84 |
| Maximum absolute peak blood flow | 3.87 ml/s STANDARD_DEVIATION 1.89 | 5.73 ml/s STANDARD_DEVIATION 3.3 | 4.80 ml/s STANDARD_DEVIATION 2.78 |
| Mean Arterial Pressure | 103.59 mmHg STANDARD_DEVIATION 9.83 | 106.01 mmHg STANDARD_DEVIATION 8.82 | 104.80 mmHg STANDARD_DEVIATION 9.26 |
| Number of Participants with Lower Limb Stents | 6 Participants | 7 Participants | 13 Participants |
| Number of Participants with Type II Diabetes Mellitus | 3 Participants | 8 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 11 Participants | 24 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Serum Endothelin-1 | 2.44 pg/ml STANDARD_DEVIATION 0.51 | 2.30 pg/ml STANDARD_DEVIATION 0.49 | 2.37 pg/ml STANDARD_DEVIATION 0.5 |
| Serum Total Nitrate | 64.32 uM STANDARD_DEVIATION 66.33 | 42.19 uM STANDARD_DEVIATION 25.74 | 53.64 uM STANDARD_DEVIATION 51.32 |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 12 Participants | 14 Participants | 26 Participants |
| SF-36 Bodily Pain | 49.57 units on a scale STANDARD_DEVIATION 29.87 | 44.93 units on a scale STANDARD_DEVIATION 14.98 | 47.17 units on a scale STANDARD_DEVIATION 23.07 |
| SF-36 General Health | 54.81 units on a scale STANDARD_DEVIATION 20.78 | 58.93 units on a scale STANDARD_DEVIATION 17.85 | 56.94 units on a scale STANDARD_DEVIATION 19.08 |
| SF-36 Mental Health | 77.86 units on a scale STANDARD_DEVIATION 17.4 | 72.00 units on a scale STANDARD_DEVIATION 19.16 | 74.83 units on a scale STANDARD_DEVIATION 18.25 |
| SF-36 Phyiscal Functioning | 45.00 units on a scale STANDARD_DEVIATION 26.02 | 42.14 units on a scale STANDARD_DEVIATION 16.14 | 43.57 units on a scale STANDARD_DEVIATION 21.29 |
| SF-36 Role Emotional | 70.24 units on a scale STANDARD_DEVIATION 31.98 | 60.71 units on a scale STANDARD_DEVIATION 33.4 | 65.48 units on a scale STANDARD_DEVIATION 32.45 |
| SF-36 Role Physical | 45.09 units on a scale STANDARD_DEVIATION 30.54 | 41.96 units on a scale STANDARD_DEVIATION 21.01 | 43.53 units on a scale STANDARD_DEVIATION 25.77 |
| SF-36 Social Functioning | 67.86 units on a scale STANDARD_DEVIATION 26.73 | 65.00 units on a scale STANDARD_DEVIATION 26.81 | 66.38 units on a scale STANDARD_DEVIATION 26.33 |
| SF-36 Vitality | 45.54 units on a scale STANDARD_DEVIATION 26.34 | 50.83 units on a scale STANDARD_DEVIATION 19.75 | 48.28 units on a scale STANDARD_DEVIATION 22.9 |
| Smoker | 7 Participants | 6 Participants | 13 Participants |
| Systolic Blood Pressure | 149.13 mmHg STANDARD_DEVIATION 12.45 | 153.54 mmHg STANDARD_DEVIATION 12.22 | 151.34 mmHg STANDARD_DEVIATION 12.33 |
| Weight | 81.38 kg STANDARD_DEVIATION 15.83 | 85.67 kg STANDARD_DEVIATION 15.77 | 83.45 kg STANDARD_DEVIATION 15.67 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 1 / 16 |
Outcome results
Primary
Blood Pressure
Participants have systolic, diastolic and mean blood pressure recording 14 times during baseline, week 3 and week 6 experimental sessions.
Time frame: 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.
Population: Includes all participants that completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Heat Thermotherapy | Blood Pressure | Systolic BP Week 3 | 146.29 mmHg | Standard Deviation 17.08 |
| Low Heat Thermotherapy | Blood Pressure | Systolic BP Week 6 | 149.84 mmHg | Standard Deviation 9.61 |
| Low Heat Thermotherapy | Blood Pressure | Diastolic BP Week 3 | 79.38 mmHg | Standard Deviation 10.74 |
| Low Heat Thermotherapy | Blood Pressure | Diastolic BP Week 6 | 80.31 mmHg | Standard Deviation 8.98 |
| Low Heat Thermotherapy | Blood Pressure | Mean Arterial Pressure Week 3 | 101.69 mmHg | Standard Deviation 12.18 |
| Low Heat Thermotherapy | Blood Pressure | Mean Arterial Pressure Week 6 | 103.48 mmHg | Standard Deviation 7.9 |
| High Heat Thermotherapy | Blood Pressure | Mean Arterial Pressure Week 3 | 102.81 mmHg | Standard Deviation 9.33 |
| High Heat Thermotherapy | Blood Pressure | Systolic BP Week 3 | 148.97 mmHg | Standard Deviation 12.51 |
| High Heat Thermotherapy | Blood Pressure | Diastolic BP Week 6 | 81.44 mmHg | Standard Deviation 8.64 |
| High Heat Thermotherapy | Blood Pressure | Systolic BP Week 6 | 150.21 mmHg | Standard Deviation 15.38 |
| High Heat Thermotherapy | Blood Pressure | Mean Arterial Pressure Week 6 | 104.36 mmHg | Standard Deviation 9.39 |
| High Heat Thermotherapy | Blood Pressure | Diastolic BP Week 3 | 79.72 mmHg | Standard Deviation 9.42 |
Primary
Circulating Levels of Endothelin-1 (pg/mL)
Blood draw
Time frame: Serum endothelin-1 levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Population: One participant was excluded as an outlier from the low heat group. One participant in the high heat group did not have blood draws
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Heat Thermotherapy | Circulating Levels of Endothelin-1 (pg/mL) | Endothelin-1 Week 3 | 2.44 pg/mL | Standard Deviation 0.66 |
| Low Heat Thermotherapy | Circulating Levels of Endothelin-1 (pg/mL) | Endothelin-1 Week 6 | 2.60 pg/mL | Standard Deviation 0.69 |
| High Heat Thermotherapy | Circulating Levels of Endothelin-1 (pg/mL) | Endothelin-1 Week 3 | 2.11 pg/mL | Standard Deviation 0.37 |
| High Heat Thermotherapy | Circulating Levels of Endothelin-1 (pg/mL) | Endothelin-1 Week 6 | 2.00 pg/mL | Standard Deviation 0.35 |
Primary
Circulating Total Nitrate Levels (mmol)
Blood Draw
Time frame: Serum total nitrate levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Population: One participant was excluded as an outlier from the low heat group. One participant in the high heat group did not have blood draws
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Heat Thermotherapy | Circulating Total Nitrate Levels (mmol) | Total Nitrate Levels Week 3 | 63.62 mmol | Standard Deviation 30.6 |
| Low Heat Thermotherapy | Circulating Total Nitrate Levels (mmol) | Total Nitrate Levels Week 6 | 58.31 mmol | Standard Deviation 29.3 |
| High Heat Thermotherapy | Circulating Total Nitrate Levels (mmol) | Total Nitrate Levels Week 3 | 47.61 mmol | Standard Deviation 21.31 |
| High Heat Thermotherapy | Circulating Total Nitrate Levels (mmol) | Total Nitrate Levels Week 6 | 42.95 mmol | Standard Deviation 19.57 |
Primary
Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes
6-minutes walk test
Time frame: Maximal walking distances on a 6mwt were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Population: Included all participants that completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Heat Thermotherapy | Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes | Week 3 | 388.75 meters | Standard Deviation 85.08 |
| Low Heat Thermotherapy | Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes | Week 6 | 404.29 meters | Standard Deviation 83.05 |
| High Heat Thermotherapy | Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes | Week 3 | 414.96 meters | Standard Deviation 109.23 |
| High Heat Thermotherapy | Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes | Week 6 | 419.73 meters | Standard Deviation 113.83 |
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.
Time frame: SF-36 questionnaires were administered at weeks 3/6 and 6/6 of the study and compared to baseline values.
Population: Includes all participants that completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Mental Health Week 3 | 81.92 units on a scale | Standard Deviation 16.9 |
| Low Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | General Health Week 6 | 55.33 units on a scale | Standard Deviation 18.48 |
| Low Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Role Physical Week 6 | 50.42 units on a scale | Standard Deviation 31.65 |
| Low Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Vitality Week 3 | 50.00 units on a scale | Standard Deviation 21.95 |
| Low Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Vitality Week 6 | 55.00 units on a scale | Standard Deviation 21.8 |
| Low Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Physical Functioning Week 6 | 42.67 units on a scale | Standard Deviation 29.43 |
| Low Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Social Functioning Week 3 | 79.81 units on a scale | Standard Deviation 30.85 |
| Low Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Bodily Pain Week 3 | 45.85 units on a scale | Standard Deviation 21.25 |
| Low Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Social Functioning Week 6 | 75.83 units on a scale | Standard Deviation 27.33 |
| Low Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Physical Functioning Week 3 | 48.08 units on a scale | Standard Deviation 27.27 |
| Low Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Role Emotinoal Week 3 | 80.77 units on a scale | Standard Deviation 27.51 |
| Low Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Bodily Pain Week 6 | 50.33 units on a scale | Standard Deviation 22.4 |
| Low Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Role Emotional Week 6 | 71.67 units on a scale | Standard Deviation 29.18 |
| Low Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Role Physical Week 3 | 50.00 units on a scale | Standard Deviation 33.46 |
| Low Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Mental Health Week 6 | 79.67 units on a scale | Standard Deviation 14.33 |
| Low Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | General Health Week 3 | 54.92 units on a scale | Standard Deviation 13.82 |
| High Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Mental Health Week 6 | 71.33 units on a scale | Standard Deviation 22.71 |
| High Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Mental Health Week 3 | 72.33 units on a scale | Standard Deviation 16.99 |
| High Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Physical Functioning Week 3 | 45.05 units on a scale | Standard Deviation 16.59 |
| High Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Physical Functioning Week 6 | 49.26 units on a scale | Standard Deviation 20.2 |
| High Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Role Physical Week 3 | 50.00 units on a scale | Standard Deviation 24.55 |
| High Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Role Physical Week 6 | 56.25 units on a scale | Standard Deviation 28.84 |
| High Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Bodily Pain Week 3 | 49.29 units on a scale | Standard Deviation 20.6 |
| High Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Bodily Pain Week 6 | 51.87 units on a scale | Standard Deviation 18.28 |
| High Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | General Health Week 3 | 61.47 units on a scale | Standard Deviation 20.2 |
| High Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | General Health Week 6 | 59.40 units on a scale | Standard Deviation 21.67 |
| High Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Vitality Week 6 | 55.00 units on a scale | Standard Deviation 22.19 |
| High Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Social Functioning Week 3 | 75.00 units on a scale | Standard Deviation 24.02 |
| High Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Social Functioning Week 6 | 72.50 units on a scale | Standard Deviation 24.64 |
| High Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Role Emotinoal Week 3 | 65.00 units on a scale | Standard Deviation 30.57 |
| High Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Role Emotional Week 6 | 64.44 units on a scale | Standard Deviation 30.12 |
| High Heat Thermotherapy | Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey | Vitality Week 3 | 52.08 units on a scale | Standard Deviation 20.41 |
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.
Time frame: Peak flows after post-occlusive reactive hyperemia were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Heat Thermotherapy | Vascular Function Assessed by Leg MRI to Measure Peak Blood Flow in Popliteal Artery (ml/s) | Week 3 | 4.25 ml/s | Standard Deviation 2.54 |
| Low Heat Thermotherapy | Vascular Function Assessed by Leg MRI to Measure Peak Blood Flow in Popliteal Artery (ml/s) | Week 6 | 4.49 ml/s | Standard Deviation 2.51 |
| High Heat Thermotherapy | Vascular Function Assessed by Leg MRI to Measure Peak Blood Flow in Popliteal Artery (ml/s) | Week 3 | 4.85 ml/s | Standard Deviation 1.94 |
| High Heat Thermotherapy | Vascular Function Assessed by Leg MRI to Measure Peak Blood Flow in Popliteal Artery (ml/s) | Week 6 | 5.49 ml/s | Standard Deviation 2.43 |
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
Time frame: Ankle-brachial index measures were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Population: Includes all participants that completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Heat Thermotherapy | 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) | Week 3 | 0.64 ratio | Standard Deviation 0.14 |
| Low Heat Thermotherapy | 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) | Week 6 | 0.64 ratio | Standard Deviation 0.12 |
| High Heat Thermotherapy | 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) | Week 3 | 0.71 ratio | Standard Deviation 0.13 |
| High Heat Thermotherapy | 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) | Week 6 | 0.71 ratio | Standard Deviation 0.11 |
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.
Time frame: 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.
Population: Includes all participants that completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Heat Thermotherapy | Vascular Function Measuring Leg Cutaneous Vascular Conductance - Measured by Laser-doppler Flowmetry of the Skin | Week 3 | 55.08 percentage of maximum conductance | Standard Deviation 3.691 |
| Low Heat Thermotherapy | Vascular Function Measuring Leg Cutaneous Vascular Conductance - Measured by Laser-doppler Flowmetry of the Skin | Week 6 | 54.29 percentage of maximum conductance | Standard Deviation 4.077 |
| High Heat Thermotherapy | Vascular Function Measuring Leg Cutaneous Vascular Conductance - Measured by Laser-doppler Flowmetry of the Skin | Week 3 | 56.09 percentage of maximum conductance | Standard Deviation 4.892 |
| High Heat Thermotherapy | Vascular Function Measuring Leg Cutaneous Vascular Conductance - Measured by Laser-doppler Flowmetry of the Skin | Week 6 | 52.66 percentage of maximum conductance | Standard Deviation 3.806 |