Registry for Chronic Venous Disease Incidence and Natural Course

NCT04487314 | Recruiting

• 1 other identifier: RPA 10.001
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicose Veins of Lower Limb

Outcome Measures

Primary Outcomes (4)

• Incidence of Chronic Venous Disease

  Number of Participants with the first identified signs of chronic venous disease according to CEAP classification (telangiectasia, varicose veins, edema)

  1 year

• Natural Course of Chronic Venous Disease

  Progression of CVD will be measured as a change in clinical class of CVD according to CEAP classification in every individual affected by CVD

  1 year

• Incidence of chronic venous insufficiency

  Number of Participants with the first identified sign of chronic venous insufficiency (venous edema, venous eczema, hyperpigmentation of the skin, lipodermatosclerosis, venous ulcer)

  1 year

• Incidence of superficial vein thrombosis

  Number of Participants with the first identified sign of superficial vein thrombosis

  1 year

Study Arms (2)

Patients without Chronic Venous Disease

Individuals who do not have signs of chronic venous diseases of lower legs according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP)

Patients with Chronic Veinous Disease

Individuals who have signs of chronic venous diseases of lower legs according to CEAP classification (telangiectases, varicose veins, venous edema, skin hyperpigmentation, lipodermatosclerosis, venous ulcer).

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The main cohort is formed from those who do not have CVD, who are affected by different factors that we register (various physical activities, the presence or absence of pregnancy, etc.). An additional cohort is formed from those who have CVD at the time of inclusion. The goal is to track the natural evolution (progression) of the disease, to evaluate the incidence and risk factors of complications. An extremely important criterion for the formation of the study population is the possibility to control the lower legs veins of observed individuals by a qualified vascular specialist. To date, a qualitative assessment of veins according to the CEAP classification is a weak point in longitudinal epidemiological studies.

You may qualify if:

• 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

You may not qualify if:

• Any invasive treatment of the chronic venous disorder in anamnesis

Sponsors & Collaborators

• Russian Phlebological Association: lead

Study Sites (1)

"Medalp" private surgery clinic

Saint Petersburg, 197350, Russia

RECRUITING

Related Links

• This is a website specially created for this register.
• The Association of Phlebologists of Russia already has 2 registers, which registered in ClinicalTrials.gov and on the basis of which clinical trials are conducted.

Central Study Contacts

Evgeny Ilyukhin, MD, PhD

CONTACT

+79218451722; evgeny@ilyukhin.info

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 27, 2020
• Study Start: August 20, 2020
• Primary Completion (Estimated): September 1, 2050
• Study Completion (Estimated): September 1, 2050
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)