Duplex UltraSound afTer Endo Revascularisation - Feasibility Randomised Control Trial (DUSTER)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- To assess feasibility of ultrasound surveillance
研究概览
简要总结
17, 000 people every year in the UK develop foot pain or wounds from blocked leg arteries. If left untreated, this can lead to amputation. Keyhole surgery is often used to balloon open the blockages before they can cause serious problems. However half of people over the next 2 years can develop further blockages, which can be identified by ultrasound scans of the leg arteries
The aim of this clinical trial is to explore the benefits of regular ultrasound checks of the leg after keyhole surgery.
In this study participants are randomly allocated to one of two groups. Half of participants will have standard clinic appointments with their vascular specialist at 1 month, 6 months and 12 months. The other half will have additional ultrasound scans of the leg arteries before their clinic appointments at 1, 6 and 12 months.
We will then look at how many people attended the scans, whether the scans could be completed and how this affected decisions to have more surgery. At the end of the trial we will look at what happened to participants in both groups.
详细描述
Phase 1: Feasibility RCT
The study is a multi-site, randomised (1:1), controlled, open label, 2 arm, feasibility trial.
DUSTER will be performed in 3 NHS vascular units at the following NHS Trusts:
- Mid and South Essex NHS Foundation Trust
- Imperial College Healthcare NHS Trust
- Manchester University NHS Trust
These sites comprise two urban and one rural site, in both the North, South and East of the country. This will help understand the effects of travel, ethnicity, and geography on attending appointments. Following NIHR INCLUDE guidance we have costed for translation of study materials / interpreters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •Adults (18y+) who have had successful lower limb endovascular therapy (angioplasty, stenting, atherectomy, lithotripsy, drug eluting balloon or stent, or combination of above) for chronic limb threatening ischaemia (ischaemic rest pain, ulceration or gangrene with arterial imaging confirming peripheral arterial disease). Technical success is defined as <30% residual stenosis in the treated segments and patient leaving hospital without a major (above ankle) amputation on study leg
- •Procedures within the last 3 weeks
- •Interventions to iliac, femoral, tibial, and pedal vessels alone or in combination
- •Endarterectomy or cutdown is permissible
- •Able to give informed consent
排除标准
- •Surgical bypass or endarterectomy alone undertaken
- •Patient unfit for or does not want any future revascularisation
- •Need for major amputation due to gas gangrene, severe Charcot deformity, extensive tissue loss with unstable foot, severe pedal disease on angiography or patient request
- •Patient unwilling or cannot attend further surveillance
- •Interventions for claudication or acute limb ischaemia or trauma
- •Patients unable to take any form of antiplatelet therapy (aspirin or clopidogrel)
- •Prior leg endovascular therapy at same anatomical location in study leg (within 1 year)
- •Currently taking part in research that may impact on the results, design, or scientific value of this study or other studies that the potential participant may be taking part in.
结局指标
主要结局
To assess feasibility of ultrasound surveillance
时间窗: 1 year
* attendance at ultrasound surveillance appointments * completion rates of components of ultrasound surveillance * of participants undergoing arterial reintervention
次要结局
- Limb Salvage(1 year)
- Quality of Life(1 Year)
- Disease specific quality of life(1 Year)
- Independence in daily activities(1 Year)
- Participant reported pain(1 Year)
- Amputations(1 Year)
- Serious reintervention complications(1 Year)
- Adverse events (cardiac/cerebrovascular)(1 Year)
- Mortality(1 Year)