The Role of Pyroptosis in Chronic Venous Disease

Inflammation Clinical Trial

— PYROCVD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03744858
• Other study ID #: ER.CZ.2018.06
• Status: Active, not recruiting
• Start date: November 12, 2018
• Est. completion date: November 12, 2020

Study information

• Verified date: November 2018
• Source: University of Cantanzaro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: November 12, 2020
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Peripheral blood draw
Peripheral vein blood draw will be performed to all participants in order to collect blood samples to be evaluated.

Locations

Country	Name	City	State
Italy	CIFL- Interuniversity Center of Phlebolymphology	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University of Cantanzaro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pyroptosis evaluation 1	NETs evaluation to be presented in ng/ml	2 years
Primary	Pyroptosis evaluation 2	Caspase-1 evaluation to be presented in pg/ml	2 years
Primary	Pyroptosis evaluation 3	IL-1 ß, IL-4, IL-10, IL-18, and TNF-a evaluation to presented in pg/ml	2 years