Varicose Veins of Lower LimbNCT06367166
Effects of Bioflavanoids on Vascular Wall Remodeling in Patients With Varicose Veins
A study testing "Venarus®" (diosmin and hesperidin), Endovenous laser ablation (EVLA) with miniphlebectomy and Elastic compression in people with Varicose Veins of Lower Limb and Varix, run by Ryazan State Medical University at 1 site in Russia.
Trial summary
The study is aimed at assessing the dynamics of changes in biochemical markers of venous wall remodeling (type 1 plasminogen activation inhibitor (PAI-1), fibronectin (fibronectin, FN), vimentin (vimentin, VM), von Willebrand factor (vWF), PECAM-1 (CD31) ) in patients with C2s-C3s varicose veins compared with healthy… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicose Veins of Lower Limb, Varix, Vascular Diseases
- What is being tested?
- "Venarus®" (diosmin and hesperidin), Endovenous laser ablation (EVLA) with miniphlebectomy and Elastic compression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2023to 1 May 2026
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study will include men or women over 18 years of age with varicose disease of the lower extremities C2-C3 according to the CEAP classification, confirmed by ultrasound duplex scanning of the veins of the lower extremities
Who cannot join
- the presence of neoplasms, previous operations on the vessels of the lower extremities, deep vein thrombosis, severe concomitant diseases, including infectious ones, pregnancy, lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effects of Bioflavonoids on Venous Wall Remodeling in Patients With Varicose Veins of the Lower Extremities
The study is aimed at assessing the dynamics of changes in biochemical markers of venous wall remodeling (type 1 plasminogen activation inhibitor (PAI-1), fibronectin (fibronectin, FN), vimentin (vimentin, VM), von Willebrand factor (vWF), PECAM-1 (CD31) ) in patients with C2s-C3s varicose veins compared with healthy volunteers while taking Venarus® (diosmin in combination with hesperidin).
Read the detailed description
The study will include 80 patients with varicose veins of the lower extremities, CEAP (CEAP classification stands for Clinical (C), Etiological (E), Anatomical (A), and Pathophysiological (P)) clinical class C2s-C3s and 20 healthy volunteers of similar age, gender, and ethnicity (100 patients altogether). The study participants will be divided into five groups: Group A: 20 patients with varicose veins who will be treated conservatively - receive the drug "Venarus®" (diosmin in combination with hesperidin) at a dosage of 1000 mg once daily for 6 months; Group B: 20 patients with varicose veins C2s-C3s who are not prescribed conservative therapy with venoactive drugs and will not undergo invasive treatment; Group C: 20 patients with varicose veins who will undergo invasive treatment (endovenous laser ablation with miniphlebectomy), followed by Venarus at a dosage of 1000 mg once daily for 6 months; Group D: 20 patients with varicose veins who will undergo invasive treatment (endovenous laser ablation with miniphlebectomy), after which no venoactive drugs will be prescribed. Group E: 20 healthy volunteers without clinical and ultrasound signs of varicose veins.
All subjects in groups A, B, C, and D will receive elastic compression.
- Conditions
- Varicose Veins of Lower Limb, Varix, Vascular Diseases, Leg Edema
- Being tested
- "Venarus®" (diosmin and hesperidin), Endovenous laser ablation (EVLA) with miniphlebectomy, Elastic compression, Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores
- Keywords
- bioflavonoids, venous remodeling, varicose veins
- Medical subject headings
- Varicose Veins, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Venarus®" (diosmin and hesperidin)Drug
Also called BIOFLAVANOIDS
"Venarus®" (diosmin and hesperidin) at a dosage of 1000 mg once daily for 6 months
Endovenous laser ablation (EVLA) with miniphlebectomyProcedure or surgery
Endovenous laser ablation will be performed under local and tumescent anesthesia, laser wavelength 1470nm.
Elastic compressionOther
All subject with varicose veins enrolled in the study will receive class 2 elastic compression (elastic stockings) after enrollment
Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scoresOther
The patients and healthy volunteers will undergo evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), Venous clinical severity (VCS) score, Visual Analog Scale (VAS) score and 20 item-ChronIc Venous dIsease quality-of-life Questionnaire (CIVIQ-20) at baseline, and 2, 3, and 6 months after enrollment
| Study group | Role | What they receive |
|---|---|---|
| А- Varicose vein patients with Conservative treatment with a venoactive drug | Experimental | 20 patients with varicose veins who will be treated conservatively - receive the drug "Venarus®" (diosmin in combination with hesperidin) at a dosage of 1000 mg once daily for 6 months along with elastic compression Receives: Drug: "Venarus®" (diosmin and hesperidin); Other: Elastic compression; Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores |
| B- Varicose veins patients without invasive treatment or a venoactive drug | Experimental | 20 patients with varicose veins C2s-C3s who are not prescribed conservative therapy with a venoactive drug and will not undergo invasive treatment; the patients will receive elastic compression Receives: Other: Elastic compression; Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores |
| C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug | Experimental | 20 patients with varicose veins who will undergo invasive treatment (endovenous laser ablation with miniphlebectomy), followed by Venarus at a dosage of 1000 mg once daily for 6 months; the patients will also receive elastic compression Receives: Drug: "Venarus®" (diosmin and hesperidin); Procedure: Endovenous laser ablation (EVLA) with miniphlebectomy; Other: Elastic compression; Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores |
| D- Varicose veins patients who will undergo EVLA | Experimental | 20 patients with varicose veins patients who will undergo invasive treatment (EVLK with miniphlebectomy), after which no venoactive drugs will be prescribed; the patients will also receive elastic compression Receives: Procedure: Endovenous laser ablation (EVLA) with miniphlebectomy; Other: Elastic compression; Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores |
| E-healthy volunteers | Experimental | 20 healthy volunteers without clinical and ultrasound signs of varicose veins receiving no treatment Receives: Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in biomarkers of venous wall remodeling
Changes in biomarkers of venous wall remodeling including vimentin, fibronectin, PAI-1, vWF, CD31
Measured: At baseline, and at 2, 3 and 6 months after the start of treatment
Changes in biomarkers expression in venous wall
Changes in expression of biomarkers of venous wall remodeling (vimentin, fibronectin, PAI-1, vWF, CD31) as assessed with Western blot techniques using the dilated veins harvested during miniphlebectomy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Apr 2023
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with varicose veins will be assigned to different treatments to assess the venous wall remodeling parameters throughout treatment
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryazan State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Igor Suchkov, Principal investigator, RyazSMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367166
- Sponsor's protocol ID
- RyazanSMU
- Status last verified
- Jul 2025
- First submitted
- 2 Oct 2023
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Bioflavonoids on Venous Wall Remodeling in Patients With Varicose Veins of the Lower Extremities
- ClinicalTrials.gov ID
- NCT06367166
- Acronym / sponsor ID
- RyazanSMU
- Conditions
- Varicose Veins of Lower Limb, Varix, Vascular Diseases, Leg Edema
- Keywords
- bioflavonoids, venous remodeling, varicose veins
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ryazan State Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 16 Apr 2024 (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.
The study is aimed at assessing the dynamics of changes in biochemical markers of venous wall remodeling (type 1 plasminogen activation inhibitor (PAI-1), fibronectin (fibronectin, FN), vimentin (vimentin, VM), von Willebrand factor (vWF), PECAM-1 (CD31) ) in patients with C2s-C3s varicose veins compared with healthy volunteers while taking Venarus® (diosmin in combination with hesperidin).
Detailed description
The study will include 80 patients with varicose veins of the lower extremities, CEAP (CEAP classification stands for Clinical (C), Etiological (E), Anatomical (A), and Pathophysiological (P)) clinical class C2s-C3s and 20 healthy volunteers of similar age, gender, and ethnicity (100 patients altogether). The study participants will be divided into five groups: Group A: 20 patients with varicose veins who will be treated conservatively - receive the drug "Venarus®" (diosmin in combination with hesperidin) at a dosage of 1000 mg once daily for 6 months; Group B: 20 patients with varicose veins C2s-C3s who are not prescribed conservative therapy with venoactive drugs and will not undergo invasive treatment; Group C: 20 patients with varicose veins who will undergo invasive treatment (endovenous laser ablation with miniphlebectomy), followed by Venarus at a dosage of 1000 mg once daily for 6 months; Group D: 20 patients with varicose veins who will undergo invasive treatment (endovenous laser ablation with miniphlebectomy), after which no venoactive drugs will be prescribed. Group E: 20 healthy volunteers without clinical and ultrasound signs of varicose veins.
All subjects in groups A, B, C, and D will receive elastic compression.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Patients with varicose veins will be assigned to different treatments to assess the venous wall remodeling parameters throughout treatment
| Arm | Type | Receives |
|---|---|---|
| А- Varicose vein patients with Conservative treatment with a venoactive drug | Experimental | Drug: "Venarus®" (diosmin and hesperidin), Other: Elastic compression, Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores20 patients with varicose veins who will be treated conservatively - receive the drug "Venarus®" (diosmin in combination with hesperidin) at a dosage of 1000 mg once daily for 6 months along with elastic compression |
| B- Varicose veins patients without invasive treatment or a venoactive drug | Experimental | Other: Elastic compression, Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores20 patients with varicose veins C2s-C3s who are not prescribed conservative therapy with a venoactive drug and will not undergo invasive treatment; the patients will receive elastic compression |
| C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug | Experimental | Drug: "Venarus®" (diosmin and hesperidin), Procedure: Endovenous laser ablation (EVLA) with miniphlebectomy, Other: Elastic compression, Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores20 patients with varicose veins who will undergo invasive treatment (endovenous laser ablation with miniphlebectomy), followed by Venarus at a dosage of 1000 mg once daily for 6 months; the patients will also receive elastic compression |
| D- Varicose veins patients who will undergo EVLA | Experimental | Procedure: Endovenous laser ablation (EVLA) with miniphlebectomy, Other: Elastic compression, Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores20 patients with varicose veins patients who will undergo invasive treatment (EVLK with miniphlebectomy), after which no venoactive drugs will be prescribed; the patients will also receive elastic compression |
| E-healthy volunteers | Experimental | Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores20 healthy volunteers without clinical and ultrasound signs of varicose veins receiving no treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study will include men or women over 18 years of age with varicose disease of the lower extremities C2-C3 according to the CEAP classification, confirmed by ultrasound duplex scanning of the veins of the lower extremities
Key exclusion criteria (1 listed)
- the presence of neoplasms, previous operations on the vessels of the lower extremities, deep vein thrombosis, severe concomitant diseases, including infectious ones, pregnancy, lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Venarus®" (diosmin and hesperidin)Also: BIOFLAVANOIDS"Venarus®" (diosmin and hesperidin) at a dosage of 1000 mg once daily for 6 months | Drug | C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug, А- Varicose vein patients with Conservative treatment with a venoactive drug |
| Endovenous laser ablation (EVLA) with miniphlebectomyEndovenous laser ablation will be performed under local and tumescent anesthesia, laser wavelength 1470nm. | Procedure or surgery | C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug, D- Varicose veins patients who will undergo EVLA |
| Elastic compressionAll subject with varicose veins enrolled in the study will receive class 2 elastic compression (elastic stockings) after enrollment | Other | B- Varicose veins patients without invasive treatment or a venoactive drug, C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug, D- Varicose veins patients who will undergo EVLA, А- Varicose vein patients with Conservative treatment with a venoactive drug |
| Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scoresThe patients and healthy volunteers will undergo evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), Venous clinical severity (VCS) score, Visual Analog Scale (VAS) score and 20 item-ChronIc Venous dIsease quality-of-life Questionnaire (CIVIQ-20) at baseline, and 2, 3, and 6 months after enrollment | Other | B- Varicose veins patients without invasive treatment or a venoactive drug, C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug, D- Varicose veins patients who will undergo EVLA, E-healthy volunteers, А- Varicose vein patients with Conservative treatment with a venoactive drug |
Primary outcome
changes in biomarkers of venous wall remodeling
Time frame: At baseline, and at 2, 3 and 6 months after the start of treatment
Changes in biomarkers of venous wall remodeling including vimentin, fibronectin, PAI-1, vWF, CD31
Changes in biomarkers expression in venous wall
Time frame: 6 months
Changes in expression of biomarkers of venous wall remodeling (vimentin, fibronectin, PAI-1, vWF, CD31) as assessed with Western blot techniques using the dilated veins harvested during miniphlebectomy
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 23 Jul 2025.
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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.
Igor Suchkov principal investigator
RyazSMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Venarus®" (diosmin and hesperidin), Endovenous laser ablation (EVLA) with miniphlebectomy and Elastic compression in people with Varicose Veins of Lower Limb and Varix, run by Ryazan State Medical University 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 1 inclusion and 1 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 23 Jul 2025. 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?
changes in biomarkers of venous wall remodeling (time frame: At baseline, and at 2, 3 and 6 months after the start of treatment). The study lists 2 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 23 Jul 2025.