Prospective Cohort Study for Varicose Veins Incidence and Natural Course

Venous Insufficiency Clinical Trial

— VINCI  

Official title:

Prospective Cohort Study for Varicose Veins Incidence and Natural Course

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04546750
• Other study ID #: RPA 7.001.
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: September 2030

Study information

• Verified date: November 2023
• Source: Russian Phlebological Association
• Contact: Igor Zolotukhin, MD, PhD
• Phone: +79255182479
• Email: zoloto70[@]bk.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2030
• Est. primary completion date: September 2030
• 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

• Thromboses, Venous
• Thrombosis
• Varicose Veins
• Varicose Veins of Lower Limb
• Venous Insufficiency
• Venous Thrombosis

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 primary varicose veins	Number of Participants with the first identified varicose veins (class C2 according to CEAP classification)	1 year
Secondary	Progression of primary varicose veins	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)	1 year
Secondary	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
Secondary	Incidence of superficial vein thrombosis	Number of participants with first episode of superficial vein thrombosis	1 year
Secondary	Incidence of reticular and telangiectatic leg veins	Number of Participants with the first identified eticular and telangiectatic leg veins ((class C1 according to CEAP classification)	1 year
Secondary	Progression of reticular and telangiectatic leg veins	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)	1 year

External Links

•   The accumulation of data will be carried out on the basis of an termless Russian epidemiological registry, ClinicalTrials.gov Identifier: NCT04487314