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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03744858
Other study ID # ER.CZ.2018.06
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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