Registry for Chronic Venous Disease Incidence and Natural Course

Varicose Veins of Lower Limb Clinical Trial

— RRCVD  

Official title:

Russian Registry for Chronic Venous Disease Incidence and Natural Course

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04487314
• Other study ID #: RPA 10.001
• Status: Recruiting
• Start date: August 20, 2020
• Est. completion date: September 1, 2050

Study information

• Verified date: November 2023
• Source: Russian Phlebological Association
• Contact: Evgeny Ilyukhin, MD, PhD
• Phone: +79218451722
• Email: evgeny[@]ilyukhin.info
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: September 1, 2050
• Est. primary completion date: September 1, 2050
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins
• Varicose Veins of Lower Limb

Locations

Country	Name	City	State
Russian Federation	"Medalp" private surgery clinic	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Russian Phlebological Association

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Incidence of superficial vein thrombosis	Number of Participants with the first identified sign of superficial vein thrombosis	1 year

External Links

•   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.
•   This is a website specially created for this register.