The Role of Pyroptosis in Chronic Venous Disease

NCT03744858 | Unknown DMC

• 1 other identifier: ER.CZ.2018.06
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Veins; Complication; Varicose Veins; Varicose Ulcer

Keywords

chronic vein disease; inflammation; pyroptosis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

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

Interventions

Peripheral blood draw PROCEDURE

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

Group A - Participants with CVD; Group B - Healthy Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Chronic Venous Disease (C1-C6 CEAP classification )

You may not qualify if:

• Peripheral artery disease
• Malignant Tumors
• Severe cardiovascular and cerebrovascular disease
• Liver and kidney failure

Sponsors & Collaborators

• University of Catanzaro: lead

Study Sites (1)

CIFL- Interuniversity Center of Phlebolymphology

Catanzaro, 88100, Italy

Location

MeSH Terms

Conditions

Inflammation; Varicose Veins; Varicose Ulcer

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Raffaele Serra, MD, PhD

  University Magna Graecia of Catanzaro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 16, 2018
• Study Start: November 12, 2018
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2020
• Last Updated: November 16, 2018

Record last verified: 2018-11

Locations

IT (1)