Actively Recruiting

Age: 10Years +
All Genders
Healthy Volunteers
ID04546750

Prospective Cohort Study for Varicose Veins Incidence and Natural Course

Led by Russian Phlebological Association · Updated on 2023-11-18

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a prospective observational study to understand the development and natural course of chronic lower limb vein disease, including varicose veins and related conditions. The study involves individuals both without varicose veins and those diagnosed with primary varicose veins, aiming to assess morbidity, risk factors, and disease progression over time. This epidemiological registry study is led by the Russian Phlebological Association and focuses on varicose veins of the lower legs and related venous conditions. Participants are divided into two groups: those without varicose veins classified as C0 or C1 according to the CEAP system, and those with varicose veins classified as C2 Ep. The study does not involve any treatments or interventions but follows these individuals over time through regular annual clinical and ultrasound examinations of their venous system. Data collection occurs yearly in the last quarter, with patient information securely maintained in a digital database that is updated continuously. Participants will attend yearly visits for clinical and ultrasound assessments to monitor the incidence and progression of varicose veins and other venous disorders such as chronic venous insufficiency and superficial vein thrombosis. Researchers will measure outcomes including new cases of primary varicose veins, disease progression, and the development of reticular and telangiectatic veins within one year. The study includes healthy volunteers aged 10 years and older and will continue through September 2030, providing long-term observation of vein health.

CONDITIONS

Brief Title

Prospective Cohort Study for Varicose Veins Incidence and Natural Course

Who Can Participate

Age: 10Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Be a family member of the researcher or the researcher themselves (spouse, children, siblings, parents)
  • Be able to attend annual clinical and ultrasound assessments of the venous system
Not Eligible

You will not qualify if you...

  • Have a history of any invasive treatment for chronic venous disorder
  • Have a history of venous thrombosis or currently have venous thrombosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surveillance

Duration - Termless with annual assessments

Participants undergo periodic annual clinical and ultrasound assessments to monitor the presence and progression of varicose veins and related venous conditions.

1 visit per year (in-person)

Trial Site Locations

Total: 1 location

1

"Medalp" private surgery clinic

Saint Petersburg, Russia, 197350

Actively Recruiting

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Research Team

I

Igor Zolotukhin, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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