Varicose Veins of Lower LimbRRCVDNCT04487314
Registry for Chronic Venous Disease Incidence and Natural Course
An observational study of Varicose Veins of Lower Limb, run by Russian Phlebological Association at 1 site in Russia.
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. 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
- How many people
- 10,000 participants
- Where
- 1 siteRussia
- Study dates
- 20 Aug 2020to 1 Sep 2050
- 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 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.
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. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
"Medalp" private surgery clinic
Saint Petersburg, Sankt-Peterburg, 197350
Evgeny Ilyukhin, PhD, euugen.iluhin@gmail.com
About this study
Official title: Russian Registry for Chronic Venous Disease Incidence and Natural Course
A prospective cohort study of patients with primary varicose veins to assess the morbidity, risk factors and development 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 promising digital database and is constantly updated.
- Conditions
- Varicose Veins of Lower Limb
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 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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 the first identified sign of superficial vein thrombosis
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 posted27 Jul 2020
- Study start20 Aug 2020
- Primary completion1 Sep 2050 (estimated)
- Study completion1 Sep 2050 (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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Phlebological Association
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evgeny Ilyukhin, Russian Phlebological Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487314
- Sponsor's protocol ID
- RPA 10.001
- Acronym
- RRCVD
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 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
- Russian Registry for Chronic Venous Disease Incidence and Natural Course
- ClinicalTrials.gov ID
- NCT04487314
- Acronym / sponsor ID
- RRCVD / RPA 10.001
- Conditions
- Varicose Veins of Lower Limb
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Russian Phlebological AssociationUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 1 Sep 2050 (estimated)
- Study completion
- 1 Sep 2050 (estimated)
- First posted
- 27 Jul 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 cohort study of patients with primary varicose veins to assess the morbidity, risk factors and development 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 promising digital database and is constantly updated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
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 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.
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 Chronic Venous Disease
Time frame: 1 year
Number of Participants with the first identified signs of chronic venous disease according to CEAP classification (telangiectasia, varicose veins, edema)
Natural Course of Chronic Venous Disease
Time frame: 1 year
Progression of CVD will be measured as a change in clinical class of CVD according to CEAP classification in every individual affected by CVD
Incidence of chronic venous insufficiency
Time frame: 1 year
Number of Participants with the first identified sign of chronic venous insufficiency (venous edema, venous eczema, hyperpigmentation of the skin, lipodermatosclerosis, venous ulcer)
Incidence of superficial vein thrombosis
Time frame: 1 year
Number of Participants with the first identified sign of superficial vein thrombosis
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.
- This is a website specially created for this register.Link provided by the sponsor.
- 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.Link 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.
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, 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: looking for participants now, 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?
Contact Evgeny Ilyukhin, MD, PhD (+79218451722, evgeny@ilyukhin.info), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Chronic Venous Disease (time frame: 1 year). The study lists 4 primary outcomes in all. 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.