Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-01-28 @ 6:52 PM
Study NCT ID:
NCT02006420
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2013-11-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Scleroderma ARFI Imaging of the Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045743', 'term': 'Scleroderma, Diffuse'}], 'ancestors': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'khannad@umich.edu', 'phone': '734-763-7182', 'title': 'Dinesh Khanna', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'single visit; less than 1 hour; no specific follow up.', 'eventGroups': [{'id': 'EG000', 'title': 'Scleroderma', 'description': 'Scleroderma participants could have limited or diffuse scleroderma Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Skin Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Scleroderma', 'description': 'Scleroderma participants could have limited or diffuse scleroderma. Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.'}], 'classes': [{'title': 'Forearm', 'categories': [{'measurements': [{'value': '2.68', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '2.07', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Thigh', 'categories': [{'measurements': [{'value': '2.23', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '2.27', 'spread': '0.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This is the p value for the mean skin thickness of the forearm.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Unequal variance assumption'}, {'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This is the p value for the mean skin stiffness of the thigh', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Unequal variance assumption'}], 'paramType': 'MEAN', 'timeFrame': 'Cross-sectional study, 1 visit, <1 hr', 'description': 'Skin stiffness was measured from the forearm and thigh of patients with scleroderma using ultrasound shear wave velocity imaging. Shear wave velocity is measured in meters per second (m/s).', 'unitOfMeasure': 'meters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Skin Stiffness as Measured by Durometer Scoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Scleroderma', 'description': 'Scleroderma Arm. Patients could have limited or diffuse scleroderma.Participants undergo durometer scoring on the forearm and thigh as part of the study.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Healthy volunteers who do not have scleroderma.Participants undergo durometer scoring on the forearm and thigh as part of the study.'}], 'classes': [{'title': 'Forearm', 'categories': [{'measurements': [{'value': '30.5', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Thigh', 'categories': [{'measurements': [{'value': '30.1', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '19.3', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'groupDescription': 'This is the p-value for the forearm', 'statisticalMethod': 'Pearson correlation', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.007', 'groupIds': ['OG000'], 'groupDescription': 'This is the p-value for the thigh', 'statisticalMethod': 'Pearson correlation', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Cross-sectional study, 1 visit, <1 hr', 'description': 'Durometer scoring of skin stiffness in two groups of patients (controls and scleroderma). Durometer measurements are expressed in standardized international durometer units ranging from 0 to 100 where 100 is harder (worse outcome) The Rex Gauge model DD-3 was used. For further reference see Arthritis and Rheumatism (Arthritis Care \\& Research) Vol. 55. No. 4, August 15, 2006, pp. 603-609. DOI 10.1002/art.22093.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Linear Relationship Between Ultrasound Skin Stiffness and Durometer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Scleroderma and Healthy Volunteers'}], 'classes': [{'title': 'Forearm', 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000'}]}]}, {'title': 'Thigh', 'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'groupDescription': 'This is the p value for the forearm.', 'statisticalMethod': 'Pearson correlation', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.007', 'groupIds': ['OG000'], 'groupDescription': 'This is the p value for the thigh', 'statisticalMethod': 'Pearson correlation', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Cross-sectional study, 1 visit, <1 hr', 'description': 'Pearson correlation assesses the linear relationship between Ultrasound skin stiffness measurements and Durometer scoring of skin stiffness.\n\nData was combined for scleroderma and control subjects to assess the relationship and association across a broad range of skin conditions.', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Landmark Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Scleroderma', 'description': 'Scleroderma Arm. Patients could have limited or diffuse scleroderma.Participants undergo durometer scoring on the forearm and thigh as part of the study.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Healthy volunteers who do not have scleroderma.Participants undergo durometer scoring on the forearm and thigh as part of the study.'}], 'classes': [{'title': 'Forearm', 'categories': [{'measurements': [{'value': '0.6667', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Thigh', 'categories': [{'measurements': [{'value': '0.58333', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cross-sectional study, 1 visit, <1 hr', 'description': 'Mean Landmark scores are on a scale of 0 to 3, 0 = normal and 3 =marked skin hardening.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Linear Relationship Between Ultrasound Skin Stiffness and Landmark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stiffness vs. Landmark', 'description': 'Scleroderma and Healthy Volunteers'}], 'classes': [{'title': 'Forearm', 'categories': [{'measurements': [{'value': '.65', 'groupId': 'OG000'}]}]}, {'title': 'Thigh', 'categories': [{'measurements': [{'value': '.55', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'groupDescription': 'This is the p-value for the forearm', 'statisticalMethod': 'Pearson correlation', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'This is the p-value for the thigh', 'statisticalMethod': 'Pearson correlation', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Cross-sectional study, 1 visit, <1 hr', 'description': 'Pearson correlation assesses the linear relationship between ultrasound skin stiffness and subjective skin scoring (Landmark) of skin stiffness in all patients (controls plus scleroderma). Data was combined for scleroderma and control subjects to assess the relationship and association across a broad range of skin conditions.', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MRSS Scores for Scleroderma Participants.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Scleroderma Participants', 'description': 'Scleroderma Participants only'}], 'classes': [{'categories': [{'measurements': [{'value': '11.27273', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '29'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cross-sectional study, 1 visit, <1 hr', 'description': 'MRSS scores exist on a scale from 0 to 51 based on scores of 0 to 3 measured in 17 locations on the body, where 0 represents overall healthy skin and 51 would be the worst outcome in all 17 locations.\n\nMRSS measures are not taken on healthy participants.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 24 scleroderma participants, data was not available for 2.'}, {'type': 'SECONDARY', 'title': 'Linear Relationship Between Ultrasound Skin Stiffness and MRSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stiffness vs. MRSS', 'description': 'Scleroderma Participants only'}], 'classes': [{'title': 'Forearm', 'categories': [{'measurements': [{'value': '0.53', 'groupId': 'OG000'}]}]}, {'title': 'Thigh', 'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000'], 'groupDescription': 'This is the p-value for the forearm', 'statisticalMethod': 'Pearson correlation', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.10', 'groupIds': ['OG000'], 'groupDescription': 'This is the p-value for the thigh', 'statisticalMethod': 'Pearson correlation', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Cross-sectional study, 1 visit, <1 hr', 'description': 'Pearson correlation assesses the linear relationships between ultrasound skin stiffness and subjective skin scoring (MRSS) of skin stiffness. MRSS is the Modified Rodnan Score. Skin thickness is measured by clinical palpation using a 0-3 scale. 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch the skin into a fold.\n\nBecause MRSS measurements were not taken for healthy participants, no correlations are provided for them. Therefore, the correlations are based on a skin stiffness and skin scoring solely for scleroderma participants.', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for 2 of 24 participants is not available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Scleroderma', 'description': 'Scleroderma participants could have limited or diffuse scleroderma Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Scleroderma', 'description': 'Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes.\n\nARFI-SVI Ultrasound: Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes.\n\nARFI-SVI Ultrasound: Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.7', 'spread': '14.6', 'groupId': 'BG000'}, {'value': '47.7', 'spread': '14.68', 'groupId': 'BG001'}, {'value': '48.2', 'spread': '14.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-17', 'studyFirstSubmitDate': '2013-11-26', 'resultsFirstSubmitDate': '2018-03-06', 'studyFirstSubmitQcDate': '2013-12-04', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-17', 'studyFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Skin Stiffness', 'timeFrame': 'Cross-sectional study, 1 visit, <1 hr', 'description': 'Skin stiffness was measured from the forearm and thigh of patients with scleroderma using ultrasound shear wave velocity imaging. Shear wave velocity is measured in meters per second (m/s).'}], 'secondaryOutcomes': [{'measure': 'Mean Skin Stiffness as Measured by Durometer Scoring', 'timeFrame': 'Cross-sectional study, 1 visit, <1 hr', 'description': 'Durometer scoring of skin stiffness in two groups of patients (controls and scleroderma). Durometer measurements are expressed in standardized international durometer units ranging from 0 to 100 where 100 is harder (worse outcome) The Rex Gauge model DD-3 was used. For further reference see Arthritis and Rheumatism (Arthritis Care \\& Research) Vol. 55. No. 4, August 15, 2006, pp. 603-609. DOI 10.1002/art.22093.'}, {'measure': 'Linear Relationship Between Ultrasound Skin Stiffness and Durometer', 'timeFrame': 'Cross-sectional study, 1 visit, <1 hr', 'description': 'Pearson correlation assesses the linear relationship between Ultrasound skin stiffness measurements and Durometer scoring of skin stiffness.\n\nData was combined for scleroderma and control subjects to assess the relationship and association across a broad range of skin conditions.'}, {'measure': 'Mean Landmark Scores', 'timeFrame': 'Cross-sectional study, 1 visit, <1 hr', 'description': 'Mean Landmark scores are on a scale of 0 to 3, 0 = normal and 3 =marked skin hardening.'}, {'measure': 'Linear Relationship Between Ultrasound Skin Stiffness and Landmark', 'timeFrame': 'Cross-sectional study, 1 visit, <1 hr', 'description': 'Pearson correlation assesses the linear relationship between ultrasound skin stiffness and subjective skin scoring (Landmark) of skin stiffness in all patients (controls plus scleroderma). Data was combined for scleroderma and control subjects to assess the relationship and association across a broad range of skin conditions.'}, {'measure': 'MRSS Scores for Scleroderma Participants.', 'timeFrame': 'Cross-sectional study, 1 visit, <1 hr', 'description': 'MRSS scores exist on a scale from 0 to 51 based on scores of 0 to 3 measured in 17 locations on the body, where 0 represents overall healthy skin and 51 would be the worst outcome in all 17 locations.\n\nMRSS measures are not taken on healthy participants.'}, {'measure': 'Linear Relationship Between Ultrasound Skin Stiffness and MRSS', 'timeFrame': 'Cross-sectional study, 1 visit, <1 hr', 'description': 'Pearson correlation assesses the linear relationships between ultrasound skin stiffness and subjective skin scoring (MRSS) of skin stiffness. MRSS is the Modified Rodnan Score. Skin thickness is measured by clinical palpation using a 0-3 scale. 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch the skin into a fold.\n\nBecause MRSS measurements were not taken for healthy participants, no correlations are provided for them. Therefore, the correlations are based on a skin stiffness and skin scoring solely for scleroderma participants.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Scleroderma']}, 'descriptionModule': {'briefSummary': 'Scleroderma and other rheumatologic conditions can affect the skin. Scleroderma in particular involves skin thickening and hardening.\n\nCurrently, looking at the degree that the skin is affected by scleroderma is measured based on a combination of a physical exam and a skin biopsy.\n\nThe researchers propose to measure skin hardness using ultrasound imaging of elasticity. They will use a technique using acoustic radiation force impulse/shear wave velocity imaging , known as ARFI/SVI).\n\nThe investigators hypothesize that ARFI/SVI may be able to distinguish between normal skin and skin affected by scleroderma.. This tool may also help to quantify the amount of fibrosis in the skin.\n\nThis type of radiologic biomarker could be used to help confirm the diagnosis of scleroderma.', 'detailedDescription': 'Scleroderma as well as numerous other rheumatologic conditions can affect the skin. Scleroderma in particular causes skin thickening and hardening.\n\nCurrently, evaluation of degree to which skin is affected by scleroderma is measured by a combination of a physical exam and skin biopsy results.\n\nThe investigators propose to measure skin hardness using ultrasound elasticity imaging, in the form of acoustic radiation force impulse/shear wave velocity imaging (ARFI/SVI).\n\nThe investigators hypothesize that ARFI/SVI may be able to distinguish normal skin from skin affected by scleroderma (and other rheumatologic conditions). And, this ultrasound technique might measure the amount of fibrosis in the dermis (skin).\n\nSuch a radiologic biomarker could be used to help confirm the diagnosis of scleroderma. In addition, it may be usable for following patients over time and measuring their response to therapy and progression of disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects are people aged 18 or over who are either healthy or who have scleroderma or another rheumatological condition.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18 years of age or older\n2. Rheumatologic disease of the skin including: Limited Scleroderma, Diffuse Scleroderma, or Eosinophilic Fascitis (Schulman's Syndrome)\n\nExclusion Criteria:\n\n1\\. None"}, 'identificationModule': {'nctId': 'NCT02006420', 'acronym': 'ARFI', 'briefTitle': 'Scleroderma ARFI Imaging of the Skin', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Acoustic Radiation Force Impulse/Shear Wave Velocity Imaging of the Skin in Scleroderma and Other Rheumatologic Diseases', 'orgStudyIdInfo': {'id': 'HUM00074229'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ARFI-SVI Ultrasound', 'description': 'Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes.', 'interventionNames': ['Device: ARFI-SVI Ultrasound']}, {'label': 'Healthy Volunteers: ARFI/SVI Ultrasound', 'description': 'Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes.', 'interventionNames': ['Device: ARFI-SVI Ultrasound']}], 'interventions': [{'name': 'ARFI-SVI Ultrasound', 'type': 'DEVICE', 'description': 'Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.', 'armGroupLabels': ['ARFI-SVI Ultrasound', 'Healthy Volunteers: ARFI/SVI Ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dinesh Khanna, MD, MS', 'investigatorAffiliation': 'University of Michigan'}}}}