Prospective Cohort Study for Varicose Veins Incidence and Natural Course

Recruiting

• Conditions: Venous Insufficiency; Varicose Veins of Lower Limb; Thromboses, Venous

• Registration Number: NCT04546750
• Lead Sponsor: Russian Phlebological Association

Brief Summary

A prospective study of individuals without varicose veins and who have primary varicose veins to assess the morbidity, risk factors and natural course 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 digital database and is constantly updated

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-09-05
• Study First Submitted QC: 2020-09-05
• Study First Posted: 2020-09-14
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18
• Primary Completion: 2030-09
• Study Completion: 2030-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 primary varicose veins	1 year	Number of Participants with the first identified varicose veins (class C2 according to CEAP classification)

Secondary 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)
Progression of primary varicose veins	1 year	The presence of varicose veins in new areas of the lower extremites (each limb is divided into 8 areas: thigh - anterior, posterior, medial, lateral area; lower leg - anterior, posterior, medial, lateral area)
Incidence of superficial vein thrombosis	1 year	Number of participants with first episode of superficial vein thrombosis
Incidence of reticular and telangiectatic leg veins	1 year	Number of Participants with the first identified eticular and telangiectatic leg veins ((class C1 according to CEAP classification)
Progression of reticular and telangiectatic leg veins	1 year	The presence of reticular and telangiectatic leg veins in new areas of the lower extremites (each limb is divided into 8 areas: thigh - anterior, posterior, medial, lateral area; lower leg - anterior, posterior, medial, lateral area)

Trial Locations

Locations (1)

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