A Randomized, Single Blind, Placebo Controlled, Multicenter Study to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for the Treatment of Symptomatic, Visible Varicose Veins With Saphenofemoral Junction (SFJ) Incompetence.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 主要终点
- The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of polidocanol injectable foam in the relief of symptoms, improvement of appearance, and overall effectiveness and safety in the treatment of varicose veins compared to placebo.
详细描述
The purpose of this study is to evaluate the efficacy of polidocanol injectable foam vs placebo treatments in relief of symptoms using two disease specific questionnaires, establishment of a minimally important difference (MID) for the questionnaires, improvement in the appearance of visible varicosities by a patient and medical assessments aided by pre and post treatment photographs, and a central independent assessor evaluating pre and post treatment photographs. In addition, the study will evaluate the efficacy of polidocanol injectable foam vs the placebo treatment in the elimination of SFJ reflux or occlusion of the treated vein, and to determine whether the placebo procedure blinds the patient to treatment assignment.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females 18-65 years old
- •VEINES Sym Score less than 75 points
- •Varicose Vein clinical classification CEAP 2, 3, 4, or 5
- •Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein
- •Superficial venous disease manifested by both symptoms and visible varicosities
- •Ability to comprehend and sign an informed consent document and completed study questionnaires in English
排除标准
- •Incompetence of the SSV which substantially contributes to the filling of visible varicose veins
- •Current or previous Deep Vein Thrombosis
- •Leg obesity
- •Peripheral arterial disease in the leg to be treated
- •Reduced mobility
- •Planned prolonged travel with limited mobility with in 4 weeks of treatment
- •History of pulmonary embolism or stroke
- •Major surgery, prolonged hospitalization or pregnancy within 3 months
- •Current anticoagulation therapy (within 7 days of enrollment)
- •Participation in a clinical study involving a investigational product within 3 months
- •Major co-existing disease or clinically significant laboratory abnormalities
- •Known allergic response to polidocanol or heparin or severe and/or multiple allergic reactions
- •Women of childbearing potential not using effective contraception one month prior to enrollment and/or unwilling to continue while on study
- •Pregnant or lactating women
- •Current alcohol or drug abuse
研究组 & 干预措施
1
Varisolve (polidocanol endovenous mircofoam)
干预措施: Varisolve (Polidocanol Endovenous Microfoam) (Drug)
2
Agitated saline
干预措施: Agitated Saline (Drug)
结局指标
主要结局
The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks
时间窗: Baseline to 8 weeks
The VVSymQ is a subset of the VEINES-Sym and consists of the 5 symptoms most relevant to patients. The raw score, which can range from 5 to 30, was transformed to a summary VVSymQ score that ranges from 0 (worst possible symptom health) to 100 (best symptom health) using the following formula: VVSymQ: (Transformed Score) = \[(Raw Score) - 5\] \* 4.
次要结局
未报告次要终点