The Role of Pyroptosis in Chronic Venous Disease

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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. 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.

Official Title
-----------------
The Role of Pyroptosis in Chronic Venous Disease and Its Pathophysiological Implication

Conditions
-----------------
Inflammation, Veins, Complication, Varicose Veins, Varicose Ulcer

Intervention / Treatment
-----------------
* Procedure: Peripheral blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Venous Disease (C1-C6 CEAP classification ) Exclusion Criteria: Peripheral artery disease Malignant Tumors Severe cardiovascular and cerebrovascular disease Liver and kidney failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A - Participants with CVD<br>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. | Procedure: Peripheral blood draw<br>* Peripheral vein blood draw will be performed to all participants in order to collect blood samples to be evaluated.<br>|
| Group B - Healthy Participants<br>Voluntary healthy subjects will undergo peripheral blood draw. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated in blood samples. | Procedure: Peripheral blood draw<br>* Peripheral vein blood draw will be performed to all participants in order to collect blood samples to be evaluated.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pyroptosis evaluation 1 | NETs evaluation to be presented in ng/ml | 2 years | 
| Pyroptosis evaluation 2 | Caspase-1 evaluation to be presented in pg/ml | 2 years | 
| Pyroptosis evaluation 3 | IL-1 β, IL-4, IL-10, IL-18, and TNF-α evaluation to presented in pg/ml | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic vein disease, inflammation, pyroptosis