Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-24 @ 7:18 PM
Study NCT ID:
NCT05113420
Status:
UNKNOWN
Last Update Posted:
2021-11-09
First Post:
2021-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Different Phlebotonic Drugs in Children With Venous Malformations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054079', 'term': 'Vascular Malformations'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C080675', 'term': 'S 5682'}, {'id': 'C053279', 'term': 'troxevasin'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-09-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2021-10-09', 'studyFirstSubmitQcDate': '2021-10-28', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Satisfaction after treatment', 'timeFrame': '1 month', 'description': 'Questionnaire'}], 'primaryOutcomes': [{'measure': 'Coagulation testing', 'timeFrame': '1 month', 'description': 'Coagulation testing'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug Effect', 'Children, Only', 'Vascular Malformations', 'Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the efficacy and safety of different phlebotonic drugs in children and to assess patient satisfaction after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children', 'eligibilityCriteria': 'Inclusion Criteria: venous malformation\n\n* venous malformation\n\nExclusion Criteria:\n\n* allergy'}, 'identificationModule': {'nctId': 'NCT05113420', 'briefTitle': 'The Efficacy and Safety of Different Phlebotonic Drugs in Children With Venous Malformations', 'organization': {'class': 'OTHER', 'fullName': 'Center for Vascular Pathology, Moscow'}, 'officialTitle': 'The Efficacy and Safety of Different Phlebotonic Drugs in Children With Venous Malformations: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'VAC_VM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Per os+topical solution(1)', 'interventionNames': ['Drug: Detralex']}, {'label': 'Per os+topical solution(2)', 'interventionNames': ['Drug: Detralex', 'Drug: Troxevasin']}, {'label': 'Per os only', 'interventionNames': ['Drug: Detralex']}, {'label': 'Topical solution only', 'interventionNames': ['Drug: Detralex', 'Drug: Troxevasin']}], 'interventions': [{'name': 'Detralex', 'type': 'DRUG', 'description': 'Diosmin+ Hesperidin', 'armGroupLabels': ['Per os only', 'Per os+topical solution(1)', 'Per os+topical solution(2)', 'Topical solution only']}, {'name': 'Troxevasin', 'type': 'DRUG', 'description': 'Troxerutin', 'armGroupLabels': ['Per os+topical solution(2)', 'Topical solution only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '109028', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Ekaterina Listovskaya', 'role': 'CONTACT'}], 'facility': 'The Vascular Anomalies Center (VAC) "Hemangioma" LLC', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Ekaterina Listovskaia', 'role': 'CONTACT', 'email': 'listovskaya_ek@outlook.com', 'phone': '+79032069027'}], 'overallOfficials': [{'name': 'Ekaterina Listovskaia, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vascular Anomalies Center (VAC) "Hemangioma" LLC.'}, {'name': 'Dmitriy Romanov, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vascular Anomalies Center (VAC) "Hemangioma" LLC.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Vascular Pathology, Moscow', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}