Varicose Veins of Lower Limb Clinical Trial
— VICTORYOfficial 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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | April 25, 2025 |
Est. primary completion date | January 25, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Adult males and females aged between 19 and under 80 years old 2. 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 3. 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 4. Patients who voluntarily provide written informed consent to participate in this clinical trial Exclusion Criteria: 1. Peripheral arterial occlusive disease in the lower limbs 2. Asymptomatic lower extremity varicose veins 3. Acute deep vein thrombosis 4. Frequent lower limb pain due to neuropathy 5. 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) 6. 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 7. 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 8. Severe renal dysfunction (serum creatinine levels more than twice the normal upper limit of the institution) at the screening date 9. Severe liver dysfunction (ALT or AST levels more than three times the normal upper limit of the institution) at the screening date 10. 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) 11. History of clinically significant psychiatric disorders or alcohol abuse 12. History of hypersensitivity reactions to the investigational drug or its ingredients 13. 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 14. Pregnant or breastfeeding women 15. Women of childbearing potential who plan to become pregnant during the clinical trial participation period 16. Individuals deemed unsuitable for participation in the clinical trial by the investigator |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yongin Severance Hospitall, Yonsei University College of Medicine | Yongin | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
AIUM 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. — View Citation
De 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. Erratum In: Eur J Vasc Endovasc Surg. 2022 Aug-Sep;64(2-3):284-285. — View Citation
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. Erratum In: J Vasc Surg Venous Lymphat Disord. 2024 Mar;12(2):101719. — View Citation
Labropoulos 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. — View Citation
Labropoulos 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6, 12 weeks | |
Secondary | 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) | 6, 12 weeks | |
Secondary | Change in varicose vein size area | The investigators will assess changes in varicose vein diameters using lower-limb venous Doppler ultrasound examinations | 6, 12 weeks | |
Secondary | Change in venous reflux volume | The investigators will assess the changes in venous reflux volume using Venous Doppler Reflux VTI × varicose vein size area | 6, 12 weeks | |
Secondary | 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®). | 6, 12 weeks | |
Secondary | 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. | 6, 12 weeks | |
Secondary | 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. | 6, 12 weeks |
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