Clinical trial NCT03744858: The Role of Pyroptosis in Chronic Venous Disease
Official title: The Role of Pyroptosis in Chronic Venous Disease and Its Pathophysiological Implication
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammation
Veins
Complication
Varicose Veins
Varicose Ulcer
Keywords: chronic vein disease
inflammation
pyroptosis
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Chronic venous disease (CVD) according clinical stages of CEAP classification:

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.

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.

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

Primary outcomes:
measure: Pyroptosis evaluation 1
timeFrame: 2 years
measure: Pyroptosis evaluation 2
timeFrame: 2 years
measure: Pyroptosis evaluation 3
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: CIFL- Interuniversity Center of Phlebolymphology
Study officials:
affiliation: University Magna Graecia of Catanzaro
name: Raffaele Serra, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: