Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT03435835
Status:
COMPLETED
Last Update Posted:
2022-08-30
First Post:
2017-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Heat Therapy to Reduce Pain and Improve Walking Tolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'brosegui@purdue.edu', 'phone': '7654962612', 'title': 'Dr. Bruno Roseguini', 'organization': 'Purdue University/Indiana University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Throughout the duration of the study (approximately 1 month).', 'eventGroups': [{'id': 'EG000', 'title': 'Sham Treatment', 'description': 'Participants were fitted with liquid-circulating trousers and water at 33°C was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States).', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Heat Therapy', 'description': 'Participants were fitted with liquid-circulating trousers and water at 43°C was circulated through the tube-lined trousers for 90 min using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37°C-38°C.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypokalemia', 'notes': 'Baseline blood draw indicated that participant had plasma potassium concentration of 2.9 (critical value). The study session was stopped and the patient was escorted to the Emergency Department.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'notes': 'After the third blood draw the patient became lightheaded, the blood pressure was 86/50.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Peak Walking Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Treatment', 'description': 'Participants were fitted with liquid-circulating trousers and water at 33°C was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States).'}, {'id': 'OG001', 'title': 'Heat Therapy', 'description': 'Participants were fitted with liquid-circulating trousers and water at 43°C was circulated through the tube-lined trousers for 90 min using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37°C-38°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '955.6', 'spread': '84.3', 'groupId': 'OG000'}, {'value': '947.7', 'spread': '88.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after exposure to a single session of heat therapy or sham treatment, up to ~20 min', 'description': 'Exercise testing was performed in a motorized treadmill (Pro 27, Woodway, St. Paul, Minnesota, United States) following the Gardner-Skinner protocol, which consists of walking at a constant speed (2 mph) with a 2%-grade increase every 2 min (Gardner et al., 1991). Participants received standardized instructions and were asked to indicate when they first began to feel leg pain with a "thumbs up" signal (defined as COT), and then give a "thumbs down" signal when they could no longer continue with the test (defined as PWT).', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Claudication Onset Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Treatment', 'description': 'Participants were fitted with liquid-circulating trousers and water at 33°C was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States).'}, {'id': 'OG001', 'title': 'Heat Therapy', 'description': 'Participants were fitted with liquid-circulating trousers and water at 43°C was circulated through the tube-lined trousers for 90 min using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37°C-38°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '452.6', 'spread': '53.2', 'groupId': 'OG000'}, {'value': '442.9', 'spread': '65.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min', 'description': 'Exercise testing was performed in a motorized treadmill (Pro 27, Woodway, St. Paul, Minnesota, United States) following the Gardner-Skinner protocol, which consists of walking at a constant speed (2 mph) with a 2%-grade increase every 2 min (Gardner et al., 1991). Participants received standardized instructions and were asked to indicate when they first began to feel leg pain with a "thumbs up" signal (defined as COT), and then give a "thumbs down" signal when they could no longer continue with the test (defined as PWT).', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Treatment', 'description': 'Participants were fitted with liquid-circulating trousers and water at 33°C was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States).'}, {'id': 'OG001', 'title': 'Heat Therapy', 'description': 'Participants were fitted with liquid-circulating trousers and water at 43°C was circulated through the tube-lined trousers for 90 min using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37°C-38°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '193.3', 'spread': '23.2', 'groupId': 'OG000'}, {'value': '189.3', 'spread': '31.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min', 'description': 'Blood pressure was measured in the left arm using a stethoscope and sphygmomanometer during exercise.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Treatment', 'description': 'Participants were fitted with liquid-circulating trousers and water at 33°C was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States).'}, {'id': 'OG001', 'title': 'Heat Therapy', 'description': 'Participants were fitted with liquid-circulating trousers and water at 43°C was circulated through the tube-lined trousers for 90 min using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37°C-38°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.2', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '73.5', 'spread': '11.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min', 'description': 'Blood pressure was measured in the left arm using a stethoscope and sphygmomanometer prior and during exercise', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Calf Tissue Saturation Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Treatment', 'description': 'Participants were fitted with liquid-circulating trousers and water at 33°C was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States).'}, {'id': 'OG001', 'title': 'Heat Therapy', 'description': 'Participants were fitted with liquid-circulating trousers and water at 43°C was circulated through the tube-lined trousers for 90 min using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37°C-38°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '43.1', 'spread': '8.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min', 'description': 'The tissue saturation index (TSI%) of the most symptomatic leg was assessed with a commercially available NIRS system (Portamon, Artinis Medical Systems, The Netherlands).', 'unitOfMeasure': '% tissue saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-exercise Plasma Endothelin-1 Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Treatment', 'description': 'Participants were fitted with liquid-circulating trousers and water at 33°C was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States).'}, {'id': 'OG001', 'title': 'Heat Therapy', 'description': 'Participants were fitted with liquid-circulating trousers and water at 43°C was circulated through the tube-lined trousers for 90 min using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37°C-38°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min. Ten minutes following completion of the incremental treadmill test, blood samples were obtained for the assessment of serum ET-1', 'description': 'Commercially available enzyme-linked immunosorbent assay kits were used to measure the plasma concentrations of ET-1 (DET100, Endothelin-1 Quantikine ELISA Kit, R\\&D Systems, Minneapolis, MN, United States)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sham, Then Heat Therapy', 'description': 'Participants were fitted with liquid-circulating trousers. In the sham treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States). At least 72 hrs following the completion of the sham treatment, patients returned to the laboratory and underwent the leg heat therapy (HT treatment). In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC.'}, {'id': 'FG001', 'title': 'Heat Therapy, Then Sham', 'description': 'Participants were fitted with liquid-circulating trousers. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC. At least 72 hrs following the completion of the HT treatment, patients returned to the laboratory and underwent the sham treatment. In the sham treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States).'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were identified and contacted by the Indiana Clinical and Translational Science Institute Research Network (ResNet) research assistants. After interest in participation was established, patients were contacted directly by the investigators. Additional study participants were identified by physicians from the Division of Vascular Surgery at Methodist Hospital.', 'preAssignmentDetails': 'Nineteen participants were consented, but three were withdrawn before receiving an experimental treatment due to the inability to safely and consistently perform the treadmill exercise test. A total of 16 participants completed all study visits.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Participants were assigned, using a randomized, crossover design, to undergo a single session of either a sham treatment (sham) or heat therapy (HT) prior to a symptom-limited cardiopulmonary treadmill exercise test. In the sham treatment session, water at 33°C was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States). In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.7', 'spread': '5.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Nineteen participants were consented, but three were withdrawn before receiving an experimental treatment due to inability to safely and consistently perform the treadmill exercise test. Baseline clinical characteristics of the 16 participants that completed all study visits are presented.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-28', 'size': 172690, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-28T10:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Subjects will not be told outright which therapy there are receiving (thermoneutral or HT) and the Cardiologist supervising the exercise test will not be told which therapy was given.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-07', 'studyFirstSubmitDate': '2017-10-27', 'resultsFirstSubmitDate': '2022-02-14', 'studyFirstSubmitQcDate': '2018-02-10', 'lastUpdatePostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-07', 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Walking Time', 'timeFrame': 'Immediately after exposure to a single session of heat therapy or sham treatment, up to ~20 min', 'description': 'Exercise testing was performed in a motorized treadmill (Pro 27, Woodway, St. Paul, Minnesota, United States) following the Gardner-Skinner protocol, which consists of walking at a constant speed (2 mph) with a 2%-grade increase every 2 min (Gardner et al., 1991). Participants received standardized instructions and were asked to indicate when they first began to feel leg pain with a "thumbs up" signal (defined as COT), and then give a "thumbs down" signal when they could no longer continue with the test (defined as PWT).'}], 'secondaryOutcomes': [{'measure': 'Claudication Onset Time', 'timeFrame': 'The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min', 'description': 'Exercise testing was performed in a motorized treadmill (Pro 27, Woodway, St. Paul, Minnesota, United States) following the Gardner-Skinner protocol, which consists of walking at a constant speed (2 mph) with a 2%-grade increase every 2 min (Gardner et al., 1991). Participants received standardized instructions and were asked to indicate when they first began to feel leg pain with a "thumbs up" signal (defined as COT), and then give a "thumbs down" signal when they could no longer continue with the test (defined as PWT).'}, {'measure': 'Peak Systolic Blood Pressure', 'timeFrame': 'The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min', 'description': 'Blood pressure was measured in the left arm using a stethoscope and sphygmomanometer during exercise.'}, {'measure': 'Peak Diastolic Blood Pressure', 'timeFrame': 'The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min', 'description': 'Blood pressure was measured in the left arm using a stethoscope and sphygmomanometer prior and during exercise'}, {'measure': 'Peak Calf Tissue Saturation Index', 'timeFrame': 'The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min', 'description': 'The tissue saturation index (TSI%) of the most symptomatic leg was assessed with a commercially available NIRS system (Portamon, Artinis Medical Systems, The Netherlands).'}, {'measure': 'Post-exercise Plasma Endothelin-1 Concentration', 'timeFrame': 'The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min. Ten minutes following completion of the incremental treadmill test, blood samples were obtained for the assessment of serum ET-1', 'description': 'Commercially available enzyme-linked immunosorbent assay kits were used to measure the plasma concentrations of ET-1 (DET100, Endothelin-1 Quantikine ELISA Kit, R\\&D Systems, Minneapolis, MN, United States)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': '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 (PAD).', 'detailedDescription': '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 the validity of HT in improving walking tolerance on PAD patents.\n\nSubjects will complete baseline assessments for eligibility, including medical history and ankle-brachial measurement. Eligible participants will be asked to report to the laboratory on 4 different occasions. The purpose of visits 1 and 2 The central hypothesis of this study, based on preliminary data, is that exposure to HT will enhance the oxygenation of calf muscles during exercise and as a result, the onset of pain will be delayed and walking performance will be enhanced. is to familiarize the participants with the treadmill walking test and assess the test-retest reliability of maximal walking time determination. On visits 3 and 4 participants will receive either heat treatment or a control treatment for 80 min prior to undergoing a symptom-limited incremental test on the treadmill.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women with stable symptomatic leg claudication for 6 months or longer.\n* Ankle brachial index \\< 0.9\n\nExclusion Criteria:\n\n* Heart Failure\n* COPD\n* Critical limb ischemia\n* Prior amputation\n* Exercise-limiting co-morbidity\n* Recent infrainguinal revascularization or planned during study period\n* Plans to change medical therapy during duration of the study\n* Active cancer\n* Chronic kidney disease\n* HIV positive, active HBV or HCV disease\n* Presence of any unsuitable comorbid clinical condition in the opinion of the PI\n* Peripheral neuropathy, numbness or paresthesia in the legs\n* Morbid obesity, BMI \\> 36 or unable to fit in water-circulating pants\n* Open wounds or ulcers on the extremity\n* Unable to walk on the treadmill'}, 'identificationModule': {'nctId': 'NCT03435835', 'briefTitle': 'Heat Therapy to Reduce Pain and Improve Walking Tolerance', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Heat Therapy to Reduce Leg Pain and Improve Walking Tolerance in Patients With Symptomatic Peripheral Artery Disease', 'orgStudyIdInfo': {'id': '1708785351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sham, then heat therapy', 'description': 'Participants were fitted with liquid-circulating trousers. In the sham-treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States). At least 72 hrs after completion of the sham treatment session, participants returned to the laboratory and received the heat therapy (HT) treatment. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC.', 'interventionNames': ['Device: Control/Sham Treatment', 'Device: Heat Therapy (HT)']}, {'type': 'EXPERIMENTAL', 'label': 'Heat therapy, then sham', 'description': 'Participants were fitted with liquid-circulating trousers. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC. At least 72 hrs after completion of the sham treatment session, participants returned to the laboratory and received the sham treatment. In the sham-treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States).', 'interventionNames': ['Device: Control/Sham Treatment', 'Device: Heat Therapy (HT)']}], 'interventions': [{'name': 'Control/Sham Treatment', 'type': 'DEVICE', 'description': 'Water at 33ºC was circulated through water-circulating trousers.', 'armGroupLabels': ['Heat therapy, then sham', 'Sham, then heat therapy']}, {'name': 'Heat Therapy (HT)', 'type': 'DEVICE', 'description': 'Water at 42-43ºC was circulated through the water-circulating trousers.', 'armGroupLabels': ['Heat therapy, then sham', 'Sham, then heat therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Raghu L Motaganahalli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roseguini, Bruno, PhD', 'class': 'INDIV'}, {'name': 'Michael Emery, MD', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Raghu Motaganahalli', 'investigatorAffiliation': 'Indiana University'}}}}