Varicose Veins of Lower LimbPhase 4VICTORYNCT05851183
Effect of Vitis Vinifera Seed Extract on Venous Reflux Time in Varicose Vein
A Phase 4 study testing Vitis Vinifera seed extract medication plus therapeutic lifestyle change and Therapeutic lifestyle change only in people with Varicose Veins of Lower Limb, run by Yonsei University at 1 site in South Korea.
Trial summary
The number of patients with lower extremity varicose veins has been increasing due to an aging population, with treatments divided into conservative and invasive methods. Current treatments can be expensive and inaccessible for some patients. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Varicose Veins of Lower Limb
- What is being tested?
- Vitis Vinifera seed extract medication plus therapeutic lifestyle change and Therapeutic lifestyle change only
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jul 2023to 30 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and females aged between 19 and under 80 years old
- Patients with the following findings on venous Doppler ultrasound examination:
- Superficial veins (such as the great saphenous vein, small saphenous vein, etc.) showing valvular reflux for 0.5 seconds or longer
- Deep veins (such as the femoral vein, etc.) showing valvular reflux for 1 second or longer
- Patients who have completed the washout period as described below by Visit 2, including the screening period:
- Analgesics, steroids, anti-inflammatory drugs, and venoactive medications (such as Entelon, etc.): at least 4 weeks
- Patients who voluntarily provide written informed consent to participate in this clinical trial
Who cannot join
- Peripheral arterial occlusive disease in the lower limbs
- Asymptomatic lower extremity varicose veins
- Acute deep vein thrombosis
- Frequent lower limb pain due to neuropathy
- Patients who have undergone or are scheduled for varicose vein procedures/surgeries (However, patients who have had a procedure or surgery more than 1 year prior to the screening date are eligible to participate)
- Patients diagnosed with systemic diseases causing edema or thrombosis, such as heart failure, endocrine diseases (hypothyroidism, Cushing's syndrome, uncontrolled diabetes), allergic reactions to medications, urticaria and angioedema, malabsorption and protein-calorie malnutrition, obstructive sleep apnea, or thrombophilia, as determined by the investigator
Show all 19Show fewer
- History of malignancy within the past 5 years, but the following cases are eligible for clinical trial participation:
- Those who have a history within the past 5 years but maintain a cured state without recurrence or metastasis
- Those who have completed treatment for their tumor and have been disease-free for at least 5 years from the screening date
- Those who have passed at least 1 year since the screening date after complete resection of basal cell carcinoma/squamous cell carcinoma, radical resection of thyroid papillary cancer, or successful treatment of cervical intraepithelial neoplasia
- Severe renal dysfunction (serum creatinine levels more than twice the normal upper limit of the institution) at the screening date
- Severe liver dysfunction (ALT or AST levels more than three times the normal upper limit of the institution) at the screening date
- Need to receive diuretics or contraindicated medications and therapies that may affect the results of this clinical trial during the study period (However, patients who have been taking antihypertensive medications (calcium channel blockers, beta-blockers, angiotensin-converting enzyme inhibitors, vasodilators, vasoconstrictors) at the same dosage for at least 4 weeks (28 days) before screening and will maintain the same dosage and administration during the study period are eligible to participate)
- History of clinically significant psychiatric disorders or alcohol abuse
- History of hypersensitivity reactions to the investigational drug or its ingredients
- Those who have participated in or are scheduled to participate in other clinical trials (investigational drugs, medical devices, health functional foods) within 12 weeks from the screening date
- Pregnant or breastfeeding women
- Women of childbearing potential who plan to become pregnant during the clinical trial participation period
- Individuals deemed unsuitable for participation in the clinical trial by the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yongin Severance Hospitall, Yonsei University College of Medicine
Yongin, Gyeonggi-do, 16995
About this study
Official title: A Prospective, Open-label, Pragmatic Randomized Controlled Trial to Demonstrate the Effect of Improving the Venous Reflux Time by Vitis Vinifera Seed Extract in Patients With Varicose Vein of Lower Extremity
The number of patients with lower extremity varicose veins has been increasing due to an aging population, with treatments divided into conservative and invasive methods. Current treatments can be expensive and inaccessible for some patients. Entelon, a relatively inexpensive intravenous drug, has shown promise in improving symptoms related to venous lymphatic dysfunction, but its objective vascular function improvement hasn't been proven. This study aims to assess the effectiveness of Vitis Vinifera seed extract (Entelon®) combined with lifestyle therapy in patients with varicose veins, using follow-up Doppler ultrasonography to measure venous reflux improvement.
Read the detailed description
Varicose veins in the lower extremities are more than the function of the valve membranes on the inside of the legs, and the heart cannot function, resulting in regurgitation in the lower half of the body. This causes blood to pool in the lower extremities and causes various symptoms. Large stalks of superficial veins and venous valves of deep veins become dysfunctional, resulting in an increase in blood vessels in the calf area with backflow of blood. The valvular insufficiency of lower extremity veins is the main cause. In general, it occurs in the great saphenous vein that flows into the deep vein from the groin, the small saphenous vein in the posterior leg, and the perforating vein in the calf. Reflux in superficial veins (e.g. great saphenous vein, small saphenous vein) and deep veins can generally be confirmed using Doppler ultrasound. Determine the direction of treatment by confirming if there is branch vein dilatation. Ultrasonography is also done on the opposite, unaffected side, even if symptoms are in only one leg.
Treatment of varicose veins can generally be divided into conservative treatment and invasive treatment, and lifestyle correction and wearing compression stockings are recommended as conservative treatment. Surgical treatment is indicated when conservative treatment is ineffective or interferes with daily life. Symptoms can be alleviated by removing superficial veins with regurgitation due to valvular insufficiency, or by inducing hardening of the causative blood vessels using high frequency or laser to block regurgitation and prevent blood flow.
However, most of these treatments are non-salary items, and are relatively expensive treatment methods that impose a large financial burden on patients. In addition, deep veins are responsible for 90% of blood transport, but surgical treatment is impossible and only conservative treatment is possible.
As a non-invasive treatment, which is an intravenous active agent, is registered as a drug to be administered, and improvement of symptoms related to venous lymphatic dysfunction (pain, lower extremity anxiety symptoms) is attracting attention. It is relatively inexpensive compared to surgical treatment, but until now, objective improvement of vascular function by drug treatment has not been proven. Vitis Vinifera seed extract (Entelon®) was launched in 1998 and its safety has already been confirmed, and the investigators have investigated the effect of lower limit volume reduction compared to placebo after administration of Vitis Vinifera seed extract in patients with edema. (Sano A, Tokutake S, Seo A. Proanthocyanidin-rich grape seed extract reduces leg swelling in healthy women during prolonged sitting. J Sci Food Agric. 2013 Feb;93(3):457-62.).
In this study, along with lifestyle therapy in patients with varicose veins, follow-up Doppler ultrasonography after administration of Entelon will be used to confirm the improvement effect of venous reflux.
- Conditions
- Varicose Veins of Lower Limb
- Being tested
- Vitis Vinifera seed extract medication plus therapeutic lifestyle change, Therapeutic lifestyle change only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitis Vinifera seed extract medication plus therapeutic lifestyle changeDrug
Also called Entelon® medication plus therapeutic lifestyle change
Administer 150mg of Vitis Vinifera seed extract (Entelon®) orally twice a day
Therapeutic lifestyle change onlyBehavioural
Implementing TLCs is a critical component of a comprehensive treatment plan for varicose veins. A key aspect of TLCs is the optimization of postural habits. Patients are advised to avoid extended sitting or standing periods, which exert additional pressure on the venous system in the lower extremities and exacerbate venous insufficiency. During rest periods, elevating the legs closer to the heart is recommended because this simple yet effective adjustment promotes venous return and reduces the gravitational burden on the venous valves of the legs. The use of graduated compression stockings during waking hours is another therapeutic lifestyle intervention that is often prescribed for patients with varicose veins. Additional TLCs include maintaining optimal body weight and engaging in regular physical exercise Walking or cycling are often recommended because of their effectiveness in promoting lower limb venous return.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic lifestyle change | Active comparator | Therapeutic lifestyle change only Receives: Behavioral: Therapeutic lifestyle change only |
| Therapeutic lifestyle change plus Vitis Vinifera extract therapy | Experimental | Therapeutic lifestyle change plus Vitis Vinifera extract medication therapy Receives: Drug: Vitis Vinifera seed extract medication plus therapeutic lifestyle change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in venous reflux time
The investigators will assess the changes in venous reflux time using lower limb venous Doppler ultrasound examinations. The examination will be performed by an independent assessor who is not aware of the group assignments to ensure unbiased assessment and measurement.
Measured: 6, 12 weeks
Secondary outcomes (6)
Improvement of venous reflux
The investigators will assess the improvement of venous reflux of target vessel (superficial vein < 0.5 seconds, deep vein < 1 seconds)
Measured: 6, 12 weeks
Change in varicose vein size area
The investigators will assess changes in varicose vein diameters using lower-limb venous Doppler ultrasound examinations
Measured: 6, 12 weeks
Change in venous reflux volume
The investigators will assess the changes in venous reflux volume using Venous Doppler Reflux VTI × varicose vein size area
Measured: 6, 12 weeks
Change of extracellular water ratio
The investigators will assess the changes in extracellular water (ECW) ratio (ECW/total body water) of target limb using body composition analyzer (ACCUNIQ BC720®).
Measured: 6, 12 weeks
Improvement in Venous Clinical Severity Score (VCSS)
The Venous Clinical Severity Score (VCSS) assesses the severity of chronic venous diseases. The score ranges from 0 (no symptoms) to 30 (severe venous disease). The scoring system considers various factors, including pain; varicose veins; venous edema; skin pigmentation; inflammation; induration; and active ulcers and their duration, size, and number. A higher VCSS indicates a worse outcome, implying a more severe state of venous disease.
Measured: 6, 12 weeks
Improvement of 14-item Chronic Venous Insufficiency quality of life Questionnaire (CIVIQ-14)
The Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ-14) is a valuable tool designed to evaluate the impact of chronic venous insufficiency on quality of life. Improvement in the CIVIQ-14 refers to the enhancement in scores, indicating better management of symptoms, greater comfort, and overall well-being of the patient over the course of treatment or intervention.
Measured: 6, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start20 Jul 2023
- Primary completion30 Sep 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Varicose Veins of Lower LimbStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators aim to compare and evaluate the improvement effects on venous reflux time in patients with lower extremity varicose veins between lifestyle modifications and the combined treatment of Vitis Vinifera seed extract (Entelon®) administration and lifestyle modifications.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Hyun Jung, Yonsei University
- Investigators
- In Hyun Jung, MD, PhD, Principal investigator, Yongin Severance Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851183
- Sponsor's protocol ID
- VICTORY trial
- Acronym
- VICTORY
- Status last verified
- Mar 2025
- First submitted
- 28 Apr 2023
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data.
Publications
Gloviczki P, Lawrence PF, Wasan SM, Meissner MH, Almeida J, Brown KR, Bush RL, Di Iorio M, Fish J, Fukaya E, Gloviczki ML, Hingorani A, Jayaraj A, Kolluri R, Murad MH, Obi AT, Ozsvath KJ, Singh MJ, Vayuvegula S, Welch HJ. The 2022 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part I. Duplex Scanning and Treatment of Superficial Truncal Reflux: Endorsed by the Society for Vascular Medicine and the International Union of Phlebology. J Vasc Surg Venous Lymphat Disord. 2023 Mar;11(2):231-261.e6. doi: 10.1016/j.jvsv.2022.09.004. Epub 2022 Oct 12.
PubMed 36326210Labropoulos N, Tiongson J, Pryor L, Tassiopoulos AK, Kang SS, Ashraf Mansour M, Baker WH. Definition of venous reflux in lower-extremity veins. J Vasc Surg. 2003 Oct;38(4):793-8. doi: 10.1016/s0741-5214(03)00424-5.
PubMed 14560232Labropoulos N, Leon LR Jr. Duplex evaluation of venous insufficiency. Semin Vasc Surg. 2005 Mar;18(1):5-9. doi: 10.1053/j.semvascsurg.2004.12.002.
PubMed 15791546De Maeseneer MG, Kakkos SK, Aherne T, Baekgaard N, Black S, Blomgren L, Giannoukas A, Gohel M, de Graaf R, Hamel-Desnos C, Jawien A, Jaworucka-Kaczorowska A, Lattimer CR, Mosti G, Noppeney T, van Rijn MJ, Stansby G, Esvs Guidelines Committee, Kolh P, Bastos Goncalves F, Chakfe N, Coscas R, de Borst GJ, Dias NV, Hinchliffe RJ, Koncar IB, Lindholt JS, Trimarchi S, Tulamo R, Twine CP, Vermassen F, Wanhainen A, Document Reviewers, Bjorck M, Labropoulos N, Lurie F, Mansilha A, Nyamekye IK, Ramirez Ortega M, Ulloa JH, Urbanek T, van Rij AM, Vuylsteke ME. Editor's Choice - European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs. Eur J Vasc Endovasc Surg. 2022 Feb;63(2):184-267. doi: 10.1016/j.ejvs.2021.12.024. Epub 2022 Jan 11. No abstract available.
PubMed 35027279AIUM Practice Parameter for the Performance of a Peripheral Venous Ultrasound Examination. J Ultrasound Med. 2020 May;39(5):E49-E56. doi: 10.1002/jum.15263. Epub 2020 Mar 12. No abstract available.
PubMed 32162338Bae S, Kim H, Son NH, Kim M, Park S, Jung IH. Vitis vinifera seed extract reduces venous reflux time in patients with varicose veins: VICTORY randomized controlled trial. J Vasc Surg Venous Lymphat Disord. 2026 Jan;14(1):102355. doi: 10.1016/j.jvsv.2025.102355. Epub 2025 Nov 15.
PubMed 41242464
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Pragmatic Randomized Controlled Trial to Demonstrate the Effect of Improving the Venous Reflux Time by Vitis Vinifera Seed Extract in Patients With Varicose Vein of Lower Extremity
- ClinicalTrials.gov ID
- NCT05851183
- Acronym / sponsor ID
- VICTORY / VICTORY trial
- Conditions
- Varicose Veins of Lower Limb
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 9 May 2023 (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 number of patients with lower extremity varicose veins has been increasing due to an aging population, with treatments divided into conservative and invasive methods. Current treatments can be expensive and inaccessible for some patients. Entelon, a relatively inexpensive intravenous drug, has shown promise in improving symptoms related to venous lymphatic dysfunction, but its objective vascular function improvement hasn't been proven. This study aims to assess the effectiveness of Vitis Vinifera seed extract (Entelon®) combined with lifestyle therapy in patients with varicose veins, using follow-up Doppler ultrasonography to measure venous reflux improvement.
Detailed description
Varicose veins in the lower extremities are more than the function of the valve membranes on the inside of the legs, and the heart cannot function, resulting in regurgitation in the lower half of the body. This causes blood to pool in the lower extremities and causes various symptoms. Large stalks of superficial veins and venous valves of deep veins become dysfunctional, resulting in an increase in blood vessels in the calf area with backflow of blood. The valvular insufficiency of lower extremity veins is the main cause. In general, it occurs in the great saphenous vein that flows into the deep vein from the groin, the small saphenous vein in the posterior leg, and the perforating vein in the calf. Reflux in superficial veins (e.g. great saphenous vein, small saphenous vein) and deep veins can generally be confirmed using Doppler ultrasound. Determine the direction of treatment by confirming if there is branch vein dilatation. Ultrasonography is also done on the opposite, unaffected side, even if symptoms are in only one leg.
Treatment of varicose veins can generally be divided into conservative treatment and invasive treatment, and lifestyle correction and wearing compression stockings are recommended as conservative treatment. Surgical treatment is indicated when conservative treatment is ineffective or interferes with daily life. Symptoms can be alleviated by removing superficial veins with regurgitation due to valvular insufficiency, or by inducing hardening of the causative blood vessels using high frequency or laser to block regurgitation and prevent blood flow.
However, most of these treatments are non-salary items, and are relatively expensive treatment methods that impose a large financial burden on patients. In addition, deep veins are responsible for 90% of blood transport, but surgical treatment is impossible and only conservative treatment is possible.
As a non-invasive treatment, which is an intravenous active agent, is registered as a drug to be administered, and improvement of symptoms related to venous lymphatic dysfunction (pain, lower extremity anxiety symptoms) is attracting attention. It is relatively inexpensive compared to surgical treatment, but until now, objective improvement of vascular function by drug treatment has not been proven. Vitis Vinifera seed extract (Entelon®) was launched in 1998 and its safety has already been confirmed, and the investigators have investigated the effect of lower limit volume reduction compared to placebo after administration of Vitis Vinifera seed extract in patients with edema. (Sano A, Tokutake S, Seo A. Proanthocyanidin-rich grape seed extract reduces leg swelling in healthy women during prolonged sitting. J Sci Food Agric. 2013 Feb;93(3):457-62.).
In this study, along with lifestyle therapy in patients with varicose veins, follow-up Doppler ultrasonography after administration of Entelon will be used to confirm the improvement effect of venous reflux.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators aim to compare and evaluate the improvement effects on venous reflux time in patients with lower extremity varicose veins between lifestyle modifications and the combined treatment of Vitis Vinifera seed extract (Entelon®) administration and lifestyle modifications.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic lifestyle change | Active comparator | Behavioral: Therapeutic lifestyle change onlyTherapeutic lifestyle change only |
| Therapeutic lifestyle change plus Vitis Vinifera extract therapy | Experimental | Drug: Vitis Vinifera seed extract medication plus therapeutic lifestyle changeTherapeutic lifestyle change plus Vitis Vinifera extract medication therapy |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult males and females aged between 19 and under 80 years old
- Patients with the following findings on venous Doppler ultrasound examination:
- Patients who have completed the washout period as described below by Visit 2, including the screening period:
- Patients who voluntarily provide written informed consent to participate in this clinical trial
Key exclusion criteria (19 listed)
- Peripheral arterial occlusive disease in the lower limbs
- Asymptomatic lower extremity varicose veins
- Acute deep vein thrombosis
- Frequent lower limb pain due to neuropathy
- Patients who have undergone or are scheduled for varicose vein procedures/surgeries (However, patients who have had a procedure or surgery more than 1 year prior to the screening date are eligible to participate)
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 |
|---|---|---|
| Vitis Vinifera seed extract medication plus therapeutic lifestyle changeAlso: Entelon® medication plus therapeutic lifestyle changeAdminister 150mg of Vitis Vinifera seed extract (Entelon®) orally twice a day | Drug | Therapeutic lifestyle change plus Vitis Vinifera extract therapy |
| Therapeutic lifestyle change onlyImplementing TLCs is a critical component of a comprehensive treatment plan for varicose veins. A key aspect of TLCs is the optimization of postural habits. Patients are advised to avoid extended sitting or standing periods, which exert additional pressure on the venous system in the lower extremities and exacerbate venous insufficiency. During rest periods, elevating the legs closer to the heart is recommended because this simple yet effective adjustment promotes venous return and reduces the gravitational burden on the venous valves of the legs. The use of graduated compression stockings during waking hours is another therapeutic lifestyle intervention that is often prescribed for patients with varicose veins. Additional TLCs include maintaining optimal body weight and engaging in regular physical exercise Walking or cycling are often recommended because of their effectiveness in promoting lower limb venous return. | Behavioural | Therapeutic lifestyle change |
Primary outcome
Change in venous reflux time
Time frame: 6, 12 weeks
The investigators will assess the changes in venous reflux time using lower limb venous Doppler ultrasound examinations. The examination will be performed by an independent assessor who is not aware of the group assignments to ensure unbiased assessment and measurement.
6 secondary outcomes
Improvement of venous reflux
Time frame: 6, 12 weeks
Change in varicose vein size area
Time frame: 6, 12 weeks
Change in venous reflux volume
Time frame: 6, 12 weeks
Change of extracellular water ratio
Time frame: 6, 12 weeks
Improvement in Venous Clinical Severity Score (VCSS)
Time frame: 6, 12 weeks
Improvement of 14-item Chronic Venous Insufficiency quality of life Questionnaire (CIVIQ-14)
Time frame: 6, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Background: PubMed 36326210Gloviczki P, Lawrence PF, Wasan SM, Meissner MH, Almeida J, Brown KR, Bush RL, Di Iorio M, Fish J, Fukaya E, Gloviczki ML, Hingorani A, Jayaraj A, Kolluri R, Murad MH, Obi AT, Ozsvath KJ, Singh MJ, Vayuvegula S, Welch HJ. The 2022 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part I. Duplex Scanning and Treatment of Superficial Truncal Reflux: Endorsed by the Society for Vascular Medicine and the International Union of Phlebology. J Vasc Surg Venous Lymphat Disord. 2023 Mar;11(2):231-261.e6. doi: 10.1016/j.jvsv.2022.09.004. Epub 2022 Oct 12.
- Background: PubMed 14560232Labropoulos N, Tiongson J, Pryor L, Tassiopoulos AK, Kang SS, Ashraf Mansour M, Baker WH. Definition of venous reflux in lower-extremity veins. J Vasc Surg. 2003 Oct;38(4):793-8. doi: 10.1016/s0741-5214(03)00424-5.
- Background: PubMed 15791546Labropoulos N, Leon LR Jr. Duplex evaluation of venous insufficiency. Semin Vasc Surg. 2005 Mar;18(1):5-9. doi: 10.1053/j.semvascsurg.2004.12.002.
- Background: PubMed 35027279De Maeseneer MG, Kakkos SK, Aherne T, Baekgaard N, Black S, Blomgren L, Giannoukas A, Gohel M, de Graaf R, Hamel-Desnos C, Jawien A, Jaworucka-Kaczorowska A, Lattimer CR, Mosti G, Noppeney T, van Rijn MJ, Stansby G, Esvs Guidelines Committee, Kolh P, Bastos Goncalves F, Chakfe N, Coscas R, de Borst GJ, Dias NV, Hinchliffe RJ, Koncar IB, Lindholt JS, Trimarchi S, Tulamo R, Twine CP, Vermassen F, Wanhainen A, Document Reviewers, Bjorck M, Labropoulos N, Lurie F, Mansilha A, Nyamekye IK, Ramirez Ortega M, Ulloa JH, Urbanek T, van Rij AM, Vuylsteke ME. Editor's Choice - European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs. Eur J Vasc Endovasc Surg. 2022 Feb;63(2):184-267. doi: 10.1016/j.ejvs.2021.12.024. Epub 2022 Jan 11. No abstract available.
- Background: PubMed 32162338AIUM Practice Parameter for the Performance of a Peripheral Venous Ultrasound Examination. J Ultrasound Med. 2020 May;39(5):E49-E56. doi: 10.1002/jum.15263. Epub 2020 Mar 12. No abstract available.
- Derived from this study: PubMed 41242464Bae S, Kim H, Son NH, Kim M, Park S, Jung IH. Vitis vinifera seed extract reduces venous reflux time in patients with varicose veins: VICTORY randomized controlled trial. J Vasc Surg Venous Lymphat Disord. 2026 Jan;14(1):102355. doi: 10.1016/j.jvsv.2025.102355. Epub 2025 Nov 15.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
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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.
In Hyun Jung, MD, PhD principal investigator
Yongin Severance Hospital, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitis Vinifera seed extract medication plus therapeutic lifestyle change and Therapeutic lifestyle change only in people with Varicose Veins of Lower Limb, run by Yonsei University at 1 site in South Korea.
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 7 inclusion and 19 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: finished, as of the sponsor's last update on 4 Mar 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in venous reflux time (time frame: 6, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05851183, which also lists 6 linked publications.
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 4 Mar 2025.