Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2018-11-12
2020-11-12
Brief Summary
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Detailed Description
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According to the Comprehensive Classification System for Chronic Venous Disorders (CEAP) divided into 6 Clinical stages:
C0: 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.
The aim of this study is to evaluate the role of pyroptosis in the onset and progression of CVD.
The 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 \[Group B\].
Peripheral 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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group A - Participants with CVD
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.
Peripheral blood draw
Peripheral vein blood draw will be performed to all participants in order to collect blood samples to be evaluated.
Group B - Healthy Participants
Voluntary healthy subjects will undergo peripheral blood draw. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated in blood samples.
Peripheral blood draw
Peripheral vein blood draw will be performed to all participants in order to collect blood samples to be evaluated.
Interventions
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Peripheral blood draw
Peripheral vein blood draw will be performed to all participants in order to collect blood samples to be evaluated.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Malignant Tumors
* Severe cardiovascular and cerebrovascular disease
* Liver and kidney failure
18 Years
ALL
Yes
Sponsors
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University of Catanzaro
OTHER
Responsible Party
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Prof. Raffaele Serra, MD, Ph.D.
Clinical Professor
Principal Investigators
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Raffaele Serra, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Magna Graecia of Catanzaro
Locations
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CIFL- Interuniversity Center of Phlebolymphology
Catanzaro, , Italy
Countries
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Other Identifiers
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ER.CZ.2018.06
Identifier Type: -
Identifier Source: org_study_id
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