Venous Ulcer: Endovenous Radiofrequency Treatment of Insufficient Perforating and Saphenous Veins Versus Multilayer Compression Bandaging - Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Ulcer Healing - 12 w
研究概览
简要总结
The aim of this study is to analyze the effect of intravenous therapy with radiofrequency for superficial and perforating venous insufficiency versus compression therapy with multilayer banding in patients with active venous ulcer. This is a controlled, randomized prospective clinical trial. People with venous ulcers and primary venous insufficiency in superficial and perforating venous system will be studied. Participants will be divided into two experimental groups: compression therapy alone, and compression therapy associated with superficial and perforating venous system ablation. Clinical aspects, improvement in patients' quality of life and interventions cost-effectiveness will be analyzed. Patients will be followed for 12 months after ulcer healing.
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 (Outcomes Assessor)
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
- •age between 18 and 80 years old
- •venous ulcer appeared at least 4 weeks, bellow knee
- •ankle-brachial index more than 0.9
- •saphenous veins insufficiency plus perforating veins reflux
- •saphenous vein diameter between 5 mm and 12 mm
- •absence of saphenous veins thrombophlebitis
- •absence of personal history of venous deep thrombosis
- •absence of ultrasound evidence of actual or previous venous deep thrombosis
- •absence of severe ankle anquilosis
排除标准
- •Unable to provide informed consent
- •Unable to receive surgical intervention due to severe clinical condition
研究组 & 干预措施
Radiofrequency treatment
Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment
干预措施: Radiofrequency ablation (Procedure)
Radiofrequency treatment
Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment
干预措施: Multilayer Compressive Bandage (Procedure)
Multilayer Compressive Bandage only
Receive only compressive treatment
干预措施: Multilayer Compressive Bandage (Procedure)
结局指标
主要结局
Ulcer Healing - 12 w
时间窗: 12 weeks
Ulcers was already healed after 12 weeks
Ulcer Healing - 24 w
时间窗: 24 weeks
Ulcers was already healed after 24 weeks
次要结局
- Ulcer Recurrence(1 year)
- Quality of life SF-36(at the begginning and up to 1 week after ulcer had healed)
- Quality of life EQ- 5D(at the begginning and up to 1 week after ulcer had healed)
- Quality of life VLU-Qol(at the begginning and up to 1 week after ulcer had healed)
- Quality of life CCVLUQ(at the begginning and up to 1 week after ulcer had healed)
- Health Economic Assessment(1 year)
研究者
Juliana Puggina
MD
University of Sao Paulo