Varicose Veins of Lower LimbVINCINCT04546750
Prospective Cohort Study for Varicose Veins Incidence and Natural Course
An observational study of Varicose Veins of Lower Limb and Thromboses, Venous, run by Russian Phlebological Association at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Varicose Veins of Lower Limb, Thromboses, Venous, Venous Insufficiency
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2020to Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The main cohort is formed from those who do not have varicose veins, 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 varicose veins 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.
Who may be able to join
- 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
Who cannot join
- Any invasive treatment of the chronic venous disorder in anamnesis
- Venous thrombosis in the anamnesis or at the time of inclusion
Trial locations and contacts
1 site in 1 country.
Russia1 site
"Medalp" private surgery clinic
Saint Petersburg, Sankt-Peterburg, 197350
About this study
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.
Read the detailed 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
- Medical subject headings
- Venous Thrombosis, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients without Varicose Veins | Individuals who do not have varicose veins of lower legs: C0, C1 classes according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP) | |
| Patients with Varicose Veins | Individuals who have varicose veins of lower legs: C2 Ep class according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of primary varicose veins
Number of Participants with the first identified varicose veins (class C2 according to CEAP classification)
Measured: 1 year
Secondary outcomes (5)
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)
Measured: 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)
Measured: 1 year
Incidence of superficial vein thrombosis
Number of participants with first episode of superficial vein thrombosis
Measured: 1 year
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)
Measured: 1 year
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Sep 2020
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose Veins of Lower LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Phlebological Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546750
- Sponsor's protocol ID
- RPA 7.001.
- Acronym
- VINCI
- Status last verified
- Jun 2026
- First submitted
- 5 Sep 2020
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study for Varicose Veins Incidence and Natural Course
- ClinicalTrials.gov ID
- NCT04546750
- Acronym / sponsor ID
- VINCI / RPA 7.001.
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Russian Phlebological AssociationUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without Varicose Veins | – | –Individuals who do not have varicose veins of lower legs: C0, C1 classes according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP) |
| Patients with Varicose Veins | – | –Individuals who have varicose veins of lower legs: C2 Ep class according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP) |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The main cohort is formed from those who do not have varicose veins, 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 varicose veins 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Any invasive treatment of the chronic venous disorder in anamnesis
- Venous thrombosis in the anamnesis or at the time of inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of primary varicose veins
Time frame: 1 year
Number of Participants with the first identified varicose veins (class C2 according to CEAP classification)
5 secondary outcomes
Progression of primary varicose veins
Time frame: 1 year
Incidence of chronic venous insufficiency
Time frame: 1 year
Incidence of superficial vein thrombosis
Time frame: 1 year
Incidence of reticular and telangiectatic leg veins
Time frame: 1 year
Progression of reticular and telangiectatic leg veins
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- The accumulation of data will be carried out on the basis of an termless Russian epidemiological registry, ClinicalTrials.gov Identifier: NCT04487314Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Varicose Veins of Lower Limb
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Mindfulness Intervention on Minimally Invasive Vascular Surgery
Anxiety, Pain
Active, not recruitingObservational study
Pain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave
Lower Extremity Varicose Veins, Radiofrequency Ablation
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins of Lower Limb and Thromboses, Venous, run by Russian Phlebological Association at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of primary varicose veins (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.