Cyanoacrylate Closure for Treatment of Venous Leg Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Rate of adverse events
研究概览
简要总结
Venous leg ulcers (VLUs) are a common wound with significant morbidity and cost, and suboptimal therapeutic options. VLUs result from chronic venous insufficiency, including venous reflux and post-thrombotic syndrome. VLU can take from months to years to heal, and 54-78% recur. Current therapies include wound, compression therapy, and medications. These treatments can increase the rate of healing, and reduce recurrence, however these therapies can be burdensome, painful, and ineffective, and despite these therapies, ~50% of wounds become chronic. Chronic VLUs can be painful, malodorous, and infected, and they often significantly limit an individual's function and mobility. An emerging therapy for symptomatic venous reflux is the closure of the culprit vein by endovenous closure with a cyanoacrylate adhesive implant. Recent studies show cyanoacrylate closure (CAC) to be a safe and effective treatment for varicosities resulting from symptomatic incompetent great saphenous veins. This study will evaluate the safety and effectiveness of CAC for VLUs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old at time of screening;
- •Venous leg ulcer;
- •Venous insufficiency (>0.5 seconds; confirmed by Doppler within last 6 months);
- •ABI of ≥0.9;
- •Capable of understanding the study and providing informed consent.
排除标准
- •Previous hypersensitivity reactions to the VenaSealTM adhesive or cyanoacrylates;
- •Acute superficial thrombophlebitis;
- •Bilateral treatment
- •Thrombophlebitis migrans;
- •Deep venous thrombosis;
- •Deep venous incompetence or occlusion in external iliac or distal veins in the affected extremity (as assessed based on spontaneity, phasicity, augmentation, pulsatility, and compressibility on ultrasound);
- •Post-thrombotic syndrome;
- •Acute sepsis;
- •Coagulation disorders;
- •Radiation or chemotherapy within 3 months of study;
- •Pregnant or lactating females;
- •Uncontrolled diabetes (HbA1c >10%);
- •Diabetic foot ulcers;
- •Current use of systemic anticoagulation;
- •Previous treatment of target vein;
- •Tortuous veins;
- •Current participation in another interventional study, or participation within 30 days prior to screening;
- •Inability to tolerate compression, or to receive endovenous treatment.
结局指标
主要结局
Rate of adverse events
时间窗: 3 months
Healing rate
时间窗: 3 months
Change in ulcer size
次要结局
- Rate of adverse events(12 months)
- Closure rate(12 months)
- Patient-reported quality of life: EuroQol Five Dimension Scale: EQ-5D-5L Health Questionnaire(12 months)
- Healing rate(12 months)