Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT01632033
Status:
COMPLETED
Last Update Posted:
2015-07-17
First Post:
2012-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Functional Evaluation With Questionnaire in Patients Investigated for Suspected Peripheral Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}], '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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-16', 'studyFirstSubmitDate': '2012-06-28', 'studyFirstSubmitQcDate': '2012-06-28', 'lastUpdatePostDateStruct': {'date': '2015-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scoring of the WELCH. Percent scored questionnaires', 'timeFrame': '1 day', 'description': 'Predetermined scored . Scoring is optional and compared to scoring of the WIQ'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Peripheral artery disease', 'claudication', 'walking', 'questionnaire'], 'conditions': ['Peripheral Artery Disease']}, 'referencesModule': {'references': [{'pmid': '23663870', 'type': 'DERIVED', 'citation': 'Ouedraogo N, Chanut M, Aubourg M, Le Hello C, Hidden V, Audat G, Harbonnier M, Abraham P. Development and evaluation of the Walking Estimated-Limitation Calculated by History questionnaire in patients with claudication. J Vasc Surg. 2013 Oct;58(4):981-8. doi: 10.1016/j.jvs.2013.03.039. Epub 2013 May 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the routine faisibility of a questionnaire to estimate walking impairment(The WELCH questionnaire) in patients investigated for suspected PAD.', 'detailedDescription': 'The WELCH and WIQ questionnaires are self completed by the patients and scored by the physician after self-completion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred for arterial leower limb investigations', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sigjned consent for the data treatment as a database\n\nExclusion Criteria:\n\n* Non french native language age \\< 18 years old'}, 'identificationModule': {'nctId': 'NCT01632033', 'acronym': 'WELCH-bis', 'briefTitle': 'Functional Evaluation With Questionnaire in Patients Investigated for Suspected Peripheral Artery Disease', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Estimation de la capacité Fonctionnelle a la Marche Par Questionnaire Clinique Chez Des Patients adressés Pour Bilan artériel Des Membres inférieurs: Etude WELCH-bis', 'orgStudyIdInfo': {'id': 'PL 2012/14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Investigation for lower limb arteries', 'description': 'Patients referred for investigation of assumed peripheral artery disease (PAD)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'overallOfficials': [{'name': 'Denise JOLIVOT, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Angers'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}