Study of the Effects of Bioflavonoids on Venous Wall Remodeling in Patients With Varicose Veins of the Lower Extremities
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in biomarkers expression in venous wall
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •the presence of neoplasms, previous operations on the vessels of the lower extremities, deep vein thrombosis, severe concomitant diseases, including infectious ones, pregnancy, lactation
研究组 & 干预措施
А- Varicose vein patients with Conservative treatment with a venoactive drug
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
干预措施: "Venarus®" (diosmin and hesperidin) (Drug)
А- Varicose vein patients with Conservative treatment with a venoactive drug
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
干预措施: Elastic compression (Other)
А- Varicose vein patients with Conservative treatment with a venoactive drug
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
干预措施: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores (Other)
B- Varicose veins patients without invasive treatment or a venoactive drug
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
干预措施: Elastic compression (Other)
B- Varicose veins patients without invasive treatment or a venoactive drug
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
干预措施: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores (Other)
C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug
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
干预措施: "Venarus®" (diosmin and hesperidin) (Drug)
C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug
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
干预措施: Endovenous laser ablation (EVLA) with miniphlebectomy (Procedure)
C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug
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
干预措施: Elastic compression (Other)
C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug
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
干预措施: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores (Other)
D- Varicose veins patients who will undergo EVLA
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
干预措施: Endovenous laser ablation (EVLA) with miniphlebectomy (Procedure)
D- Varicose veins patients who will undergo EVLA
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
干预措施: Elastic compression (Other)
D- Varicose veins patients who will undergo EVLA
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
干预措施: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores (Other)
E-healthy volunteers
20 healthy volunteers without clinical and ultrasound signs of varicose veins receiving no treatment
干预措施: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores (Other)
结局指标
主要结局
Changes in biomarkers expression in venous wall
时间窗: 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
changes in biomarkers of venous wall remodeling
时间窗: 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
次要结局
未报告次要终点