NCT04484168Unknown不适用
Axial Ablation Versus Terminal Interruption of the Reflux Source (AAVTIRS): A Randomised Controlled Trial
University College Hospital Galway1 个研究点 分布在 1 个国家目标入组 308 人开始时间: 2020年7月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Ulcer healing
研究概览
简要总结
This randomised trial aims to compare the effect on ulcer healing of different means of managing venous reflux in the lower limb. It is a non-inferiority trial comparing endovenous ablation of the axial (Saphenous and other large veins) veins of the lowere limb, versus terminal interruption of the reflux source (TIRS). For the purposes of this trial TIRS will be achieved using foam sclerotherapy of the distal tributaries in the immediate vicinity of the ulcer being treated.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or recurrent venous leg ulcer
- •Long or short saphenous vein reflux confirmed on ultrasound assessment, defined as retrograde flow lasting for >0.5 seconds
- •Ankle-Brachial pressure Index (ABI) ≥ 0.8 (if ulceration prevents ABI Toe-Brachial Index(TBI) ≥ 0.5 acceptable), or a palpable pulse
- •Ulcer size between 1 and 200 cm2
- •Patient suitable for full compression bandaging
排除标准
- •Pregnancy (or breastfeeding and needing to feed within 48 hours of treatment)
- •Active infection of ulcer, or infection within the last two weeks
- •Leg ulcer of non-venous aetiology as determined by clinical assessment
- •Isolated perforator vein reflux only
- •Evidence of deep venous insufficiency or thrombosis
- •Known hypersensitivity to Sotradecol or similar sclerosants
- •Previous inability to tolerate compression bandages
- •Presence of any contraindications for the use of compression bandages:
- •Absence of a palpable pulse, and Ankle Brachial Index (ABI) <0.8
- •Decompensated congestive cardiac failure (NYHA Class IV)
- •Known hypersensitivity to any of the component materials
- •Patients unable to provide informed consent
- •Patients attending the leg ulcer clinic already will be excluded from enrolment with the same ulcer but will be eligible to enrol with a contralateral ulcer. Recurrent ipsilateral ulcers will not be excluded.
结局指标
主要结局
Ulcer healing
时间窗: 6 months
The main outcome measure is the proportion of ulcers which have healed within the follow up period
次要结局
- Ulcer Healing(3 months)
- Wound Progress(6 months)
- Change in Venous disease related quality of Live(6 months)
- Reduction in ulcer size(6 months)
- Relative Reduction in ulcer size(6 months)
- Change in overall venous disease(6 months)
研究者
Colum Keohane
Specialist Registrar in Vascular Surgery
University College Hospital Galway
研究点 (1)
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