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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Heat Thermotherapy | Active Comparator | 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. |
|
| High Heat Thermotherapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Heat Thermotherapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
MRI Exclusions:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Tesini Roseguini, PhD | Purdue University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States | ||
| Richard L. Roudebush VA Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes | 6-minutes walk test | Included all participants that completed the study. | Posted | Mean | Standard Deviation | meters | Maximal walking distances on a 6mwt were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values. |
|
Adverse event data was collected for each participant over the course of 6 weeks of treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surface level burn | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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Some PC-MRI data was unreliable or lost due to errors in the scanning HR monitor. Erroneous data sets were removed, which reduced the power for PC-MRI flow-related variables.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bruno Roseguini, Assistant Professor | Purdue University | (765) 496-2612 | brosegui@purdue.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2019 | Dec 12, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 30, 2018 | Dec 12, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| High Heat Thermotherapy | Device | 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. |
|
| Peak flows after post-occlusive reactive hyperemia were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values. |
| 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. |
| 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. |
| 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. |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Ankle-Brachial Index | The ankle-brachial index represents the highest systolic pressure taken from the brachial artery divided by the highest systolic pressure obtained from the dorsalis pedis and posterior tibial arteries. This represents a ratio of upper limb blood pressure to lower limb blood pressure and is a hallmark diagnostic measure for peripheral artery disease. | Mean | Standard Deviation | Ratio |
|
| Number of Participants with Lower Limb Stents | Count of Participants | Participants |
|
| Number of Participants with Type II Diabetes Mellitus | Count of Participants | Participants |
|
| Smoker | Count of Participants | Participants |
|
| 6 minute walk test distance | Mean | Standard Deviation | meters |
|
| Maximum absolute peak blood flow | Some MRI outputs were affected by technological problems and the data was subsequently removed from the final dataset. Addtionally, patients who could not undergo MRI due to non-compatible stenting or claustrophobia were also removed. | Mean | Standard Deviation | ml/s |
|
| Serum Endothelin-1 | 1 participant could not under go blood draws and 1 participant's samples were deemed an outlier and subsequently removed. | Mean | Standard Deviation | pg/ml |
|
| Serum Total Nitrate | 1 participant could not under go blood draws. | Mean | Standard Deviation | uM |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Mean Arterial Pressure | Mean | Standard Deviation | mmHg |
|
| Cutaneous Vascular Conductance | 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. | Mean | Standard Deviation | Percentage of maximum conductance |
|
| SF-36 | All scales are scored 1-100, with 1 being the poorest rating and 100 being the most optimal. | Mean | Standard Deviation | units on a scale |
|
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. |
|
|
| Primary | Blood Pressure | Participants have systolic, diastolic and mean blood pressure recording 14 times during baseline, week 3 and week 6 experimental sessions. | Includes all participants that completed the study. | Posted | Mean | Standard Deviation | mmHg | 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 | One participant was excluded as an outlier from the low heat group. One participant in the high heat group did not have blood draws | Posted | Mean | Standard Deviation | pg/mL | 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 | One participant was excluded as an outlier from the low heat group. One participant in the high heat group did not have blood draws | Posted | Mean | Standard Deviation | mmol | 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. | Posted | Mean | Standard Deviation | 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. |
|
|
|
| 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 | Includes all participants that completed the study. | Posted | Mean | Standard Deviation | ratio | 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. | Includes all participants that completed the study. | Posted | Mean | Standard Deviation | percentage of maximum conductance | 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. | Includes all participants that completed the study. | Posted | Mean | Standard Deviation | units on a scale | SF-36 questionnaires were administered at weeks 3/6 and 6/6 of the study and compared to baseline values. |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 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. | 0 | 16 | 1 | 16 | 0 | 16 |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Diastolic BP Week 3 |
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| Diastolic BP Week 6 |
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| Mean Arterial Pressure Week 3 |
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| Mean Arterial Pressure Week 6 |
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| Role Physical Week 3 |
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| Role Physical Week 6 |
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| Bodily Pain Week 3 |
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| Bodily Pain Week 6 |
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| General Health Week 3 |
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| General Health Week 6 |
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| Vitality Week 3 |
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| Vitality Week 6 |
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| Social Functioning Week 3 |
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| Social Functioning Week 6 |
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| Role Emotinoal Week 3 |
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| Role Emotional Week 6 |
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| Mental Health Week 3 |
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| Mental Health Week 6 |
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