A Randomised Clinical Trial to Compare Early Versus Delayed Endovenous Treatment of Superficial Venous Reflux in Patients With Chronic Venous Ulceration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Time to Ulcer Healing From Date of Randomisation to Date of Healing up to 365 Days
研究概览
简要总结
The EVRA study evaluates the effects of early endovenous ablation on ulcer healing in patients with chronic venous ulceration. Half the patients are randomised to receive early endovenous ablation (within 2 weeks) and half to standard care
详细描述
A large number of patients (around 1% of the adult population) suffer from an ulcer (break in the skin surface) near the ankle. In most people, such an injury should heal up within a week or two. However, when there is an underlying problem with the skin, ulcers do not heal and may result in longstanding (chronic), painful, smelly and embarrassing wounds. The ulcers are often due to varicose veins in the legs, which can cause skin breakdown and ulcer formation. To get the ulcer to heal, the current best treatment is to wear a tight compression bandage with multiple layers, 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 injecting a medicine into the varicose vein (sclerotherapy) or treating the vein with heat ablation to seal it (using laser or radiofrequency), in an outpatient setting may help the ulcers to heal more quickly and (like surgery) reduce the chance of the ulcer coming back. These techniques can be carried out in the outpatient setting and are much better tolerated by patients in comparison to surgery. The aim of this study is to see whether early treatment of varicose veins using sclerotherapy or heat ablation 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)
盲法说明
Blinded assessment of ulcer healing photos
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 (at the discretion of local research team)
- •Patients who are unable to tolerate any multilayer compression bandaging / stockings will be excluded. However, concordance with compression therapy can be variable for patients at different times. Patients who are generally compliant with compression, but unable to tolerate the bandages for short periods will still be eligible to inclusion. A period of non-compliance with compression bandages will not be considered a protocol violation, but a normal variation within the spectrum of 'standard therapy'.
- •Inability of the patient to receive prompt endovenous intervention by recruiting centre
- •Pregnancy (female participants of reproductive age will be eligible for inclusion in the study, subject to a negative pregnancy test prior to randomisation)
- •Leg ulcer of non-venous aetiology (as assessed by responsible clinician)
- •Patient deemed to require skin grafting
结局指标
主要结局
Time to Ulcer Healing From Date of Randomisation to Date of Healing up to 365 Days
时间窗: time from date of randomisation to date of healing up to 365 days
For the purposes of this study, ulcer healing is defined as complete re-epithelialisation of all ulceration on the randomised (reference) leg in the absence of a scab (eschar) with no dressing required.
次要结局
- EuroQol-5 Dimensions (EQ-5D)(6 weeks post randomisation, 6 months, 12 months)
- Health Economic Assessment(Baseline, 6 weeks, 6 months, 12 months)
- Clinical Success - VCSS(at 6 weeks)
- Clinical Success - Complications(up to 12 months)
- Percentage of Participants With Ulcer Healing(24 weeks & time to ulcer healing up to 365 days)
- Ulcer Recurrence / Ulcer Free Time(Up to 12 months (and with the extension, up to 5 years (median approximately 3.7 years)))
- Clinical Success - Presence of Residual / Recurrent Reflux in the Veins(at 6 weeks)
- Quality Of Life Questionnaire up to 365 Days(6 weeks post randomisation, 6 months, 12 months)
- Generic (SF-36) Quality of Life Assessment(6 weeks post randomisation, 6 months, 12 months)