Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-02-20 @ 3:37 PM
Study NCT ID:
NCT02754804
Status:
COMPLETED
Last Update Posted:
2020-08-14
First Post:
2016-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Claudication, Systematic Evaluation of Limp on Treadmill
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-13', 'studyFirstSubmitDate': '2016-04-16', 'studyFirstSubmitQcDate': '2016-04-27', 'lastUpdatePostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Root mean square (RMS) of the electromyogram signal', 'timeFrame': 'Evaluation is complete immediately at the end of each walking test. (The end of the walking period is the end of participation of each patient, no follow up of patients)', 'description': 'Calculation for the difference (change) in RMS value at the end vs.beginning of the walking test (RMS is calculated over 15 sec at rest and 15 sec just before the end of the walking period)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Peripheral Artery Disease']}, 'descriptionModule': {'briefSummary': 'Vascular claudication is a common cause of functional limitation. This painful condition is a source overall muscle deconditioning in the peripheral arterial diseased (PAD) patient leading gradually to a state accented inactivity. The characterization of the claudication as it results from a proximal or distal ischemia has never carried out. Investigators will analyze dynamic pedometer parameter throughout walking tests in PAD patients with claudication', 'detailedDescription': 'Patients referred for exercise tests on treadmill for the quantification of walking ability will gave a recording of their walking parameters through an instrumented treadmill recording biomechanic parameters (surface electromyography, walking pace; force of the foot/treadmill interface, length of the step.. etc.) Analysis will be performed until walking is stopped due to usual claudication during a constant load 2 miles per hour 10% slope treadmill procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients complaining claudication and referred for a treadmill test', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referred for treadmill testing\n* Age \\> 18\n* Claudication\n* Covered by the French Healthcare system\n* Consent to participate\n\nExclusion Criteria:\n\n* Unstable angina\n* History of lower limb osteo articular rheumatologic disease\n* Lower limb amputation\n* Cardiac or respiratory failure\n* Neurologic disease'}, 'identificationModule': {'nctId': 'NCT02754804', 'acronym': 'CLAUSEL', 'briefTitle': 'Claudication, Systematic Evaluation of Limp on Treadmill', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': "Claudication et Fatigue Musculaire de l'artériopathe", 'orgStudyIdInfo': {'id': '2016-A000052-49'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PAD patients', 'description': 'Patients with grade 1 claudication Measurement of biomechanic parameters while walking on treadmill', 'interventionNames': ['Device: Biomechanic parameters']}], 'interventions': [{'name': 'Biomechanic parameters', 'type': 'DEVICE', 'description': 'recording of biomechanic parameters and surface electromyography at the thigh and calf level throughout the walking period, in PAD patients .', 'armGroupLabels': ['PAD patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'Centre hospitalier universitaire', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'overallOfficials': [{'name': 'pierre Abraham, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Angers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}