Registry for Chronic Venous Disease Incidence and Natural Course

Recruiting

• Conditions: Varicose Veins of Lower Limb

• Registration Number: NCT04487314
• Lead Sponsor: Russian Phlebological Association

Brief Summary

A prospective cohort study of patients with primary varicose veins to assess the morbidity, risk factors and development of chronic lower limb vein disease.

Detailed Description

Multicenter prospective cohort observational study based on a termless epidemiological registry.

Periodic inspection and collection of data from the subjects is carried out annually, in the last quarter of the current year.

Patient data is recorded in a promising digital database and is constantly updated.

Study Timeline

• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-27
• Study Start: 2020-08-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18
• Primary Completion: 2050-09-01
• Study Completion: 2050-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• A family members of the researcher (spouse, childrens, brothers and sisters, parents) or the researcher himself
• The possibility of annual clinical and ultrasound assessment of the venous system of the observed individuals

Exclusion Criteria

• Any invasive treatment of the chronic venous disorder in anamnesis
• Venous thrombosis in the anamnesis or at the time of inclusion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of chronic venous insufficiency	1 year	Number of Participants with the first identified sign of chronic venous insufficiency (venous edema, venous eczema, hyperpigmentation of the skin, lipodermatosclerosis, venous ulcer)
Incidence of superficial vein thrombosis	1 year	Number of Participants with the first identified sign of superficial vein thrombosis
Incidence of Chronic Venous Disease	1 year	Number of Participants with the first identified signs of chronic venous disease according to CEAP classification (telangiectasia, varicose veins, edema)
Natural Course of Chronic Venous Disease	1 year	Progression of CVD will be measured as a change in clinical class of CVD according to CEAP classification in every individual affected by CVD

Trial Locations

Locations (1)

"Medalp" private surgery clinic; 🇷🇺 Saint Petersburg, Russian Federation