Endovenous MechanO-Chemical Ablation Plus Compression Versus CompreSSion Alone in Chronic Venous Ulcers Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Participants with active ulcer diameter from absent (score 0) to severe (score 3).
研究概览
简要总结
This study will be looking at the effect of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging vs multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's).
详细描述
The most severe form of chronic venous disease is venous ulceration with an overall prevalence of about 1% in the adult population. Venous ulcers significantly impair quality of life, and their treatment places a heavy financial burden upon healthcare systems.
To get the ulcer to heal, the current best treatment is to wear a compression bandage with multiple layers, with which about 60% of these ulcers will heal within 6 months.
There is evidence that treatment of the varicose veins by sahenous veins stripping will prevent the ulcer recurrence.
Recent studies have suggested that novel proceduress of superficial truncal reflux elimination, such as foam sclerotherapy or treating the saphenous veins with termal (laser or radiofrequency) ablation to seal it effectively, may help the ulcers to heal more quickly and increase recurrence-free rate. These techniques can be carried out in the outpatient setting and are much better tolerated by patients in comparison to surgery.
At the same time, no studies which compared compression plus endovenous mechanochemical ablation (MOCA) vs. compression alone in chronic venous ulcers have been conducted to date.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age > 18 years.
- •Current leg ulceration of greater than 6 weeks.
- •Great saphenous vein (GSV) incompetence with reflux at least down to the knee level.
- •Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C
- •Able to give informed consent to participate in the study after reading the patient information documentation.
- •Ankle Brachial Pressure Index (ABPI) ≥ 0.8.
排除标准
- •Postoperative varicose veins disease recurrence.
- •Patients who are unable to tolerate any multilayer compression bandaging / stockings will be excluded.
- •Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome.
- •History of pulmonary embolism or stroke.
- •Current anticoagulation therapy (within 7 days of enrollment).
- •Pregnant or lactating women.
结局指标
主要结局
Number of Participants with active ulcer diameter from absent (score 0) to severe (score 3).
时间窗: 6-12 months
None (0), Diameter less than 2 cm (1), Diameter 2-6 cm (2), Diameter more than 6 cm (3)
Number of Participants with skin Pigmentation from absent (score 0) to severe (score 3).
时间窗: 6-12 months
None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
Number of Participants with varicose Veins from absent (score 0) to severe (score 3).
时间窗: 6-12 months
None (0), Few, scattered (1), Confined to calf or thigh (2) Involve calf and thigh (3)
Number of Participants with induration from absent (score 0) to severe (score 3).
时间窗: 6-12 months
None (0), Limited to perimalleolar area (1), Involving lower third of calf (2), Involving more than lower third of calf (3)
Number of Participants with active ulcers from absent (score 0) to severe (score 3).
时间窗: 6-12 months
None (0), 1 (1), 2 (2), more than 2 (3)
次要结局
- Number of Participants with ulcer recurrence-free rate (no - score 0, yes - score 1)(3-24 months)
研究者
Vladimir Khryshchanovich
Professor
Belarusian State Medical University