Treatment of Reticular Leg Veins: a Prospective, Randomized, Comparative Clinical Trial of a 1064 nm Nd:YAG Long Pulse Laser, Combined Treatment of a 1064 nm Nd:YAG Long Pulse Laser and Sclerotherapy vs. Sclerotherapy Alone.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Disappearance of the reticular vein
研究概览
简要总结
Treatment of reticular veins with a 1064 nm long-pulsed Nd:YAG laser and combination of a 1064 nm Nd:YAG long pulse laser and sclerotherapy should be no less effective than sclerotherapy alone, and have a frequency of adverse events less then sclerotherapy alone.
详细描述
Reticular leg veins are mostly an aesthetic problem. Sclerotherapy is considered the gold standard for treatment them. However, this method has a high frequency of long persistent hyperpigmentation which decreases the patients' satisfaction. It is a reason to find another method of treatment. Another possible technique to treat reticular veins is the Nd:YAG long pulse 1064 nm transdermal laser or Nd:YAG laser combined with injection sclerotherapy. There are a few studies comparing sclerotherapy with laser treatment and combined treatment with sclerotherapy. But there are no prospective, randomized, comparative clinical trials of all three methods: the 1064 nm Nd:YAG long pulse laser, combined treatment of a 1064 nm Nd:YAG long pulse laser with sclerotherapy and sclerotherapy alone. The aim of current study is the efficacy assessment of the 1064 nm long-pulsed Nd:YAG laser, combined treatment of the 1064 nm Nd:YAG long pulse laser with sclerotherapy and sclerotherapy alone for the treatment of reticular leg veins and analysis of side effects to establish advantages and disadvantage of these methods and find the best option for treatment of reticular leg veins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women over 18
- •reticular veins
- •signed informed consent to participate in the study
排除标准
- •diabetes mellitus
- •pregnancy or lactation
- •malignant neoplasms
- •inability or unwillingness of the patient to wear compression stockings
- •hypersensitivity to the polidocanol, cold, sunlight
- •concomitant diseases: bronchial asthma, severe liver and kidney disease, acute thrombosis and thrombophlebitis, infection of the skin and/or soft tissues, infectious diseases, arteriosclerosis, diabetic angiopathy, heart defects requiring surgery, fever, toxic hyperthyroidism, obesity, tuberculosis, sepsis, violation of the cellular composition of the blood, all diseases requiring bed rest, heart disease with decompensation phenomena,
- •known hereditary thrombophilia.
- •period after treatment of alcoholism
- •reception of oral contraceptives
- •sedentary lifestyle
结局指标
主要结局
Disappearance of the reticular vein
时间窗: 6 months
The clearing of the vessels on the six-point scale (from 0 to 5 points): 5 - total disappearance of the matting (100% efficacy), 4 - disappearance of around 80%, 3 - disappearance of around 60%, 2 - disappearance of around 40%, 1 - disappearance of around 20%, 0 - no changes.
次要结局
- Patient Satisfaction After Treatment(6 months)
- Intensity of hyperpigmentation(6 months)
- Pain during the procedure: Numerical Rating Scale(immediately after the procedure)
研究者
Oksana Bukina
Director, Clinical Research
Derzhavin Tambov State University