Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-27 @ 4:07 PM
Study NCT ID:
NCT03744858
Status:
UNKNOWN
Last Update Posted:
2018-11-16
First Post:
2018-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Pyroptosis in Chronic Venous Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, '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': '2018-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-11-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-15', 'studyFirstSubmitDate': '2018-11-12', 'studyFirstSubmitQcDate': '2018-11-15', 'lastUpdatePostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pyroptosis evaluation 1', 'timeFrame': '2 years', 'description': 'NETs evaluation to be presented in ng/ml'}, {'measure': 'Pyroptosis evaluation 2', 'timeFrame': '2 years', 'description': 'Caspase-1 evaluation to be presented in pg/ml'}, {'measure': 'Pyroptosis evaluation 3', 'timeFrame': '2 years', 'description': 'IL-1 β, IL-4, IL-10, IL-18, and TNF-α evaluation to presented in pg/ml'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic vein disease', 'inflammation', 'pyroptosis'], 'conditions': ['Inflammation', 'Veins', 'Complication', 'Varicose Veins', 'Varicose Ulcer']}, 'descriptionModule': {'briefSummary': 'Enrollment criteria and clinical data collection: following the principles of medical ethics, the development of inclusion and exclusion criteria. Selecting 200 cases of chronic venous disease (CVD) according to the Comprehensive Classification System for Chronic Venous Disorders (CEAP) divided into 6 Clinical stages (C1-C6) (Group A). Selecting 200 healthy participants without CVD (C0) as controls (Group B). Blood samples will be collected from both groups. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated between the two groups and between the subgroups, according to clinical stage, in group A.', 'detailedDescription': 'Pyroptosis is a pro-inflammatory form of regulated cell death and is dependent on networks of extracellular fibers (NET,s), on the enzymatic activity of inflammatory proteases that belong to the family of cysteine-dependent aspartate-specific proteases (caspase), and cytokines. The role of inflammation has been previously demonstrated in chronic venous disease (CVD), which is a condition that affects up to 80% of adult population in western countries.\n\nAccording to the Comprehensive Classification System for Chronic Venous Disorders (CEAP) divided into 6 Clinical stages:\n\nC0: no visible or palpable signs of venous disease. C1: telangiectasies or reticular veins. C2: varicose veins. C3: edema. C4a: pigmentation and eczema. C4b: lipodermatosclerosis and atrophie blanche. C5: healed venous ulcer. C6: active venous ulcer.\n\nThe aim of this study is to evaluate the role of pyroptosis in the onset and progression of CVD.\n\nThe Investigators will select 200 participants with chronic venous disease (CVD) according to Clinical stage of CEAP (C1-C6 patients) \\[Group A\\] . The investigators will also select 200 healthy participants without CVD (C0) as controls \\[Group B\\].\n\nPeripheral vein blood samples will be collected from both groups. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated between the two groups and between the subgroups of group A, according to clinical stage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Chronic venous disease (CVD) according clinical stages of CEAP classification:\n\nC0: no visible or palpable signs of venous disease. C1: telangiectasies or reticular veins. C2: varicose veins. C3: edema. C4a: pigmentation and eczema. C4b: lipodermatosclerosis and atrophie blanche. C5: healed venous ulcer. C6: active venous ulcer.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic Venous Disease (C1-C6 CEAP classification )\n\nExclusion Criteria:\n\n* Peripheral artery disease\n* Malignant Tumors\n* Severe cardiovascular and cerebrovascular disease\n* Liver and kidney failure'}, 'identificationModule': {'nctId': 'NCT03744858', 'acronym': 'PYROCVD', 'briefTitle': 'The Role of Pyroptosis in Chronic Venous Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Catanzaro'}, 'officialTitle': 'The Role of Pyroptosis in Chronic Venous Disease and Its Pathophysiological Implication', 'orgStudyIdInfo': {'id': 'ER.CZ.2018.06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A - Participants with CVD', 'description': 'Patients with chronic venous disease (CVD) will undergo peripheral blood draw. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated in blood samples.', 'interventionNames': ['Procedure: Peripheral blood draw']}, {'label': 'Group B - Healthy Participants', 'description': 'Voluntary healthy subjects will undergo peripheral blood draw. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated in blood samples.', 'interventionNames': ['Procedure: Peripheral blood draw']}], 'interventions': [{'name': 'Peripheral blood draw', 'type': 'PROCEDURE', 'description': 'Peripheral vein blood draw will be performed to all participants in order to collect blood samples to be evaluated.', 'armGroupLabels': ['Group A - Participants with CVD', 'Group B - Healthy Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': 'CIFL- Interuniversity Center of Phlebolymphology', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}], 'overallOfficials': [{'name': 'Raffaele Serra, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Magna Graecia of Catanzaro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catanzaro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Prof. Raffaele Serra, MD, Ph.D.', 'investigatorAffiliation': 'University of Catanzaro'}}}}