Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-04 @ 3:30 AM
Study NCT ID:
NCT03813758
Status:
UNKNOWN
Last Update Posted:
2019-08-07
First Post:
2019-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inter-observer and Intra-observer Variability of the Wrinkle Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-05', 'studyFirstSubmitDate': '2019-01-16', 'studyFirstSubmitQcDate': '2019-01-21', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'wrinkle test', 'timeFrame': '40 min', 'description': 'wrinkle of the skin in the finger compaared to the finger witout digital nerve injury'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wrinkle Test']}, 'descriptionModule': {'briefSummary': 'Skin wrinkling of the fingers following immersion in warm water depends on intact sympathetic innervation. It is abolished by lesions affecting both central and peripheral sympathetic pathways. It affords a simple and reliable clinical test of sympathetic function.', 'detailedDescription': 'Fingertip skin wrinkling after prolonged immersion in water is a well-recognized phenomenon, whereas a denervated digit does not exhibit normal skin wrinkling while a finger with a regenerated or repaired nerve shows at least partial reappearance of wrinkling. This is the basis for the bedside immersion-wrinkling test of autonomic digital nerve function. The exact mechanism of fingertip skin wrinkling is still subject to controversy. the purpose of this study is to examine the Inter-observer and Intra-observer Variability of the Wrinkle Test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients after suture of full cut of digital nerve', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients after suture of full cut of digital nerve\n\nExclusion Criteria:\n\n* other nerve injury'}, 'identificationModule': {'nctId': 'NCT03813758', 'briefTitle': 'Inter-observer and Intra-observer Variability of the Wrinkle Test', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'Inter-observer and Intra-observer Variability of the Wrinkle Test and the Optimum Time Need for the Test. Pilot Study', 'orgStudyIdInfo': {'id': '134-18-EMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'finger after digital nerve cut', 'interventionNames': ['Diagnostic Test: wrinkle test']}, {'label': 'healthy finger', 'interventionNames': ['Diagnostic Test: wrinkle test']}], 'interventions': [{'name': 'wrinkle test', 'type': 'DIAGNOSTIC_TEST', 'description': 'soaking in 40 deg water for 40 min. every 10 min the hand will be photo', 'armGroupLabels': ['finger after digital nerve cut', 'healthy finger']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18101', 'city': 'Afula', 'country': 'Israel', 'facility': 'HaEmek medical center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'guy rubin', 'investigatorAffiliation': 'HaEmek Medical Center, Israel'}}}}