Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-28 @ 11:00 PM
Study NCT ID:
NCT05071651
Status:
UNKNOWN
Last Update Posted:
2021-10-08
First Post:
2021-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiological Characteristics and Prevention Methods of Blisters in Ultra-trail Runners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-03-09', 'releaseDate': '2021-12-17'}], 'estimatedResultsFirstSubmitDate': '2021-12-17'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-07', 'studyFirstSubmitDate': '2021-08-23', 'studyFirstSubmitQcDate': '2021-10-07', 'lastUpdatePostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention methods used before an ultra-trail via a self-questionnaire', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Prevention methods used before an ultra-trail'}], 'secondaryOutcomes': [{'measure': 'Location of blisters, via a self-questionnaire', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Location of blisters on the feet'}, {'measure': 'Presence or not of blisters at the end of the ultra-trail or at the time of abandonment', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence or not of blisters at the end'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sport Injury', 'Blister of Foot']}, 'descriptionModule': {'briefSummary': 'PRIMARY OBJECTIVE : To evaluate the methods of prevention of the appearance of blisters set up by the runners before and during an ultra-trail\n\nSECONDARY OBJECTIVES :\n\nTo evaluate :\n\n* The main locations of blisters.\n* The severity of blisters\n* The effectiveness of prevention methods To evaluate the incidence of blisters in an ultra-trail context.', 'detailedDescription': 'MAIN JUDGEMENT CRITERIA :\n\nPrevention methods used before an ultra-trail via a self-questionnaire\n\nSECONDARY JUDGING CRITERIA : Location of blisters, via a self-questionnaire Presence or not of blisters at the end of the ultra-trail or at the time of abandonment\n\nSTUDY SCHEME : Post-race questioning'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ultra runners', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ultra-trail participants with validated registration\n\nExclusion Criteria:\n\n* Presence of blisters or other skin lesions on the feet before the race'}, 'identificationModule': {'nctId': 'NCT05071651', 'briefTitle': 'Epidemiological Characteristics and Prevention Methods of Blisters in Ultra-trail Runners', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Formation et de Recherche en Médecine de Montagne'}, 'officialTitle': "Caractéristiques épidémiologiques et méthodes de prévention Des Ampoules Chez Les Coureurs d'Ultra-trail", 'orgStudyIdInfo': {'id': 'Blisters-stop 1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Chamonix', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Corentin Tanné, MD', 'role': 'CONTACT', 'email': 'C.Tanne@ch-sallanches-chamonix.fr', 'phone': '0450473105'}], 'facility': 'Ifremmont', 'geoPoint': {'lat': 45.92375, 'lon': 6.86933}}], 'centralContacts': [{'name': 'Corentin Tanné, MD', 'role': 'CONTACT', 'email': 'C.Tanne@ch-sallanches-chamonix.fr', 'phone': '0450473105'}], 'overallOfficials': [{'name': 'Corentin Tanné, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de Formation et de Recherche en Médecine de Montagne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Formation et de Recherche en Médecine de Montagne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-12-17', 'type': 'RELEASE'}, {'date': '2022-03-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Institut de Formation et de Recherche en Médecine de Montagne'}}}}