The Role of Pyroptosis in Chronic Venous Disease (PYROCVD)

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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammation; Varicose Veins; Varicose Ulcer; Complication; Veins
• Intervention / Treatment: Procedure: Peripheral blood draw

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • CIFL- Interuniversity Center of Phlebolymphology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: 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.	Procedure: Peripheral blood draw; Peripheral vein blood draw will be performed to all participants in order to collect blood samples to be evaluated.

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

Collaborators and Investigators

• Sponsor: University of Catanzaro
• Investigators: Principal Investigator: Raffaele Serra, MD, PhD, University Magna Graecia of Catanzaro

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Anticipated): November 12, 2019
• Study Completion (Anticipated): November 12, 2020

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): November 16, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: pyroptosis; inflammation; chronic vein disease
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Inflammation; Varicose Ulcer; Varicose Veins
• Other Study ID Numbers: ER.CZ.2018.06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No