NCT03744858

The Role of Pyroptosis in Chronic Venous Disease

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: University of Catanzaro · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inflammation
• Veins
• Complication
• Varicose Veins
• Varicose Ulcer

Interventions

Type	Name	Description
PROCEDURE	Peripheral blood draw	Peripheral vein blood draw will be performed to all participants in order to collect blood samples to be evaluated.

Timeline

• Start date: 2018-11-12
• Primary completion: 2019-11-12
• Completion: 2020-11-12
• First posted: 2018-11-16
• Last updated: 2018-11-16

Locations

1 site across 1 country: Italy