Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2025-12-31 @ 5:15 PM
Study NCT ID:
NCT05099861
Status:
UNKNOWN
Last Update Posted:
2023-02-13
First Post:
2021-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Anatomy of Superficial Veins of Lower Limbs
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': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2021-10-18', 'studyFirstSubmitQcDate': '2021-10-18', 'lastUpdatePostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Anatomy of superficial Veins of Lower Limbs', 'timeFrame': '2022-2024', 'description': 'the anatomy observed by ultrasonography imaging focus on communicans between small saphenous vein and great saphenous vein'}], 'secondaryOutcomes': [{'measure': 'The Anatomy of Superficial Veins of Lower Limbs: junction saphenopopliteal', 'timeFrame': '2022-2024', 'description': 'clinical anatomy of saphenopopliteal junction and its variations observed by ultrasound imaging'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['small saphenous vein', 'great saphenous vein', 'saphenopopliteal junction', 'venae intersaphenae'], 'conditions': ['Saphenous Vein Injury']}, 'descriptionModule': {'briefSummary': 'The study is focused on clinical anatomy of superficial veins of lower limbs. We are mapping their anatomy via ultrasonography. We are focusing on saphenopopliteal junction and communicants between small saphenous vein and great saphenous vein.', 'detailedDescription': 'Research project is focused on superficial veins of lower extremities, especially their clinical anatomy. Superficial veins are located within the compartimentum saphenum. The function of superficial veins is drainage of intradermal and epifascial spaces. Superficial veins and their function are fundamental in development of chronic venous disorder. These veins are physiologically connected with deep venous system via perforators but also between each other via communicanting veins. Communicanting veins between small saphenous vein and great saphenous vein have not been described yet, particularly because of their variations. Clinically important is also the saphenopopliteal junction in the fossa poplitea. This region features many variations, which were described in many studies. Also, the nomenclature of saphenopopliteal juction is not standardised in comparison to the saphenofemoral junction. Moreover, many articles are pointing out that there were not specified all potential drainage ways of the cranial extension of small saphenous vein (extesio cranialis). Articles are uniform neither in its prevalence nor in its terminology.\n\nThe knowledge of connections between the superficial and deep venous systems as well as knowledge of communicanting veins between superficial veins is important for diagnosis and proper treatment of chronic venous disorder. Variabilities of these veins can play fundamental role in choosing the proper graft for aorto-coronary bypass grafting. The ununiformed nomenclature of superficial veins, their communicating veins and junctions can cause misleading preoperative diagnosis and overlooking of these structures in clinical practise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'European population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women and men\n* age 18-80\n\nExclusion Criteria:\n\n* wounds on lower limbs'}, 'identificationModule': {'nctId': 'NCT05099861', 'briefTitle': 'Clinical Anatomy of Superficial Veins of Lower Limbs', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Clinical Anatomy of Superficial Veins of Lower Limbs', 'orgStudyIdInfo': {'id': 'CHU185797621'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy volunteers', 'description': 'Healthy volunteers with no sign of internal disease. Age 18-50, both women and men.', 'interventionNames': ['Other: No intervention']}, {'label': 'patients with internal disease', 'description': 'Patients with internal disease, both women and men.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'this is an observational study', 'armGroupLabels': ['healthy volunteers', 'patients with internal disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12200', 'city': 'Prague', 'country': 'Czechia', 'facility': 'First faculty of medicine, Charles University', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Michaela Hronová, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '1. faculty of Medicine, Charles University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MUDr.', 'investigatorFullName': 'MUDr. Michaela Hronova', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}