The Effectiveness of Compression and Early Glue Ablation of Saphenous Vein Reflux Compared With Compression Alone in the Healing of Venous Ulcer, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Time to ulcer healing
研究概览
简要总结
The study evaluates the effects of early endovenous glue ablation on ulcer healing in patients with chronic venous ulceration. Half the patients are randomized to receive early endovenous ablation (within 2 weeks) and a half to standard care
详细描述
To get the venous leg ulcer to heal, the current best treatment is to wear a multi-component compression bandage, with which about 60% of these ulcers will heal within 24 weeks. There is evidence that treatment of the varicose veins by surgery will prevent the ulcer from returning after it has healed. Recent studies have suggested that newer techniques of treating varicose veins, such as sclerotherapy, laser or radiofrequency in an outpatient setting may help the ulcers to heal more quickly and reduce the chance of the ulcer recurrence. The aim of this study is to see whether early treatment of varicose veins using endovenous glue embolization helps with 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current leg ulceration of greater than 6 weeks, but less than 6 months duration
- •Able to give informed consent to participate in the study after reading the patient information documentation
- •Patient age > 18 years
- •Ankle Brachial Pressure Index (ABPI) ≥ 0.8
- •Superficial venous disease on colour duplex assessment deemed to be significant enough to warrant ablation by the treating clinician (either primary or recurrent venous reflux)
排除标准
- •Presence of deep venous occlusive disease or other conditions precluding superficial venous intervention
- •Patients who are unable to tolerate any multilayer compression bandaging / stockings will be excluded.
- •The inability of the patient to receive the prompt endovenous intervention
- •Pregnancy (female participants of reproductive age will be eligible for inclusion in the study, subject to a negative pregnancy test prior to randomisation)
结局指标
主要结局
Time to ulcer healing
时间窗: time from date of randomisation to date of healing within the 12 month study period
For the purposes of this study, ulcer healing is defined as complete re-epithelialization of all ulceration on the randomized (reference) leg in the absence of a scab (eschar) with no dressing required.
次要结局
- Quality Of Life SF36(6 weeks post randomisation, 6 months, 12 months)
- Quality Of Life CIVIQ-20(6 weeks post randomisation, 6 months, 12 months)
- Quality Of Life EQ5D(6 weeks post randomisation, 6 months, 12 months)
- Ulcer Healing Rate(24 weeks & time to ulcer healing within the 12 month study period)
- Ulcer recurrence / Ulcer Free Time(Up to 12 months)
- Clinical Success - Presence of residual / recurrent varicose veins(at 6 weeks)
- Clinical Success - VCSS(at 6 weeks)
- Clinical Success - Complications(up to 12 months)