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Active, Not Recruiting

NCT Number: NCT04546750

Prospective Cohort Study for Varicose Veins Incidence and Natural Course

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Varicose Veins of Lower Limb Cardiovascular Diseases Embolism and Thrombosis Thromboses, Venous Thrombosis Vascular Diseases Venous Insufficiency Venous Thrombosis

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

"Medalp" private surgery clinic

Saint Petersburg, Sankt-Peterburg, 197350, Russia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of primary varicose veins

    Time frame: 1 year

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

Secondary outcomes

  1. Progression of primary varicose veins

    Time frame: 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)

  2. Incidence of chronic venous insufficiency

    Time frame: 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)

  3. Incidence of superficial vein thrombosis

    Time frame: 1 year

    Number of participants with first episode of superficial vein thrombosis

  4. Incidence of reticular and telangiectatic leg veins

    Time frame: 1 year

    Number of Participants with the first identified eticular and telangiectatic leg veins ((class C1 according to CEAP classification)

  5. Progression of reticular and telangiectatic leg veins

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Russian Phlebological Association

Other

Registry information

Acronym: VINCI

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Sep 14, 2020
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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