Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2026-01-31 @ 2:59 PM
Study NCT ID:
NCT03101761
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2017-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characteristics and the Future of the City Chilblains
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002647', 'term': 'Chilblains'}], 'ancestors': [{'id': 'D005627', 'term': 'Frostbite'}, {'id': 'D000067390', 'term': 'Cold Injury'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2017-03-17', 'studyFirstSubmitQcDate': '2017-03-29', 'lastUpdatePostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Évaluation of chilblains' topography", 'timeFrame': 'Day 1', 'description': 'This assessment consists to evaluate the chilblains topography, vasospastic profile and presence or not of another acrosyndrome'}], 'secondaryOutcomes': [{'measure': "Questionnaire of assessment of chilblains' evolution", 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chilblains']}, 'descriptionModule': {'briefSummary': "Chilblains are cutaneous lesions affecting extremities (foot and fingers) with erythemic papules, evolving by painful relapse due to cold and sudden reheating.\n\nThis pathology is currently poorly understood while it's frequent.\n\nThe aim of the study is to evaluate all the characteristics of this pathology by reporting clinical and biological data of patient consulting for chilblains; and the other point is to assess the evolution of these patients.", 'detailedDescription': 'Investigators are going to collect data on patient medical report to fill up a case report form. And in a second time they call patient by phone to ask him/her about the evolution of their pathology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'every patient consulting for chilblains between 2012 and 2014', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patient consulting for chilblains\n* diagnostic of chilblain during the consultation\n\nExclusion Criteria:\n\n* patients consulting for other reason than chilblains\n* patient who can't reply by telephonic call"}, 'identificationModule': {'nctId': 'NCT03101761', 'briefTitle': 'Characteristics and the Future of the City Chilblains', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Characteristics and the Future of the City Chilblains', 'orgStudyIdInfo': {'id': 'ENGELURES'}}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Groupe Hospitalier Paris Saint Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Pascal PRIOLLET, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Groupe Hospitalier Paries St JOSEPH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}