Can a Dedicated Chronic Limb-threatening Ischaemia (CLTI) Clinic Improve Patient Self
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- EuroQoL-5D Visual Acuity Scale (VAS) Score
研究概览
简要总结
CLTI is the most severe form of peripheral arterial disease. Patients with the condition require investigation and management (typically in the form of revascularisation surgery) to salvage the limb. Traditionally, patients with the condition are admitted into hospital for their management, but with the advent of regional vascular networks, this is becoming increasingly difficult.
Recently, the Vascular Society of Great Britain and Ireland have advocated for the use of dedicated CLTI clinics to overcome this problem. Whilst there is burgeoning evidence for their clinical benefit, there is a lack of patient reported outcomes to measure their impact on patient selr-reported quality of life. We would like to determine if this service benefits its users as much as the clinical outcomes suggest it does.
详细描述
Chronic limb-threatening ischaemia (CLTI) is the most severe form of peripheral arterial disease (PAD). It affects 1% of the population and its incidence is expected to rise. It is a condition where the circulation to one, or both limbs is inadequate. It requires investigation and may require surgery in order to improve the blood flow to the affected limb(s). Without improvement in circulation, ulcers and gangrene set in, and the only cure is a major limb amputation.
Vascular surgery units in the United Kingdom have undergone centralisation into regional networks over the last decade in order to consolidate vascular surgery into 'high volume centres' to provide high quality care and better outcomes for patients.
However, national analysis of the performance of units has demonstrated that only 50% of CLTI patients are revascularised within the 'deliberately-challenging timeline' issued by the Vascular Society of Great Britain and Ireland (Birmpili et al., 2021; Vascular Society of Great Britain and Ireland, 2019).
CLTI already comprises more than 50% of vascular unit workload and the prevalence of CLTI is expected to rise, further increasing the burden on vascular services (Fowkes et al., 2016; Vascular Society of Great Britain and Ireland, 2018, 2021).
There is ample evidence demonstrating a strong inverse correlation between the provision of specialist outpatient clinics in the assessment and management of diabetic foot ulcers and major lower limb amputation (Joret et al., 2019; M Kerr, Rayman, & Jeffcoate, 2014; Marion Kerr, 2017; Monteiro-soares, Vale-lima, Martiniano, Dias, & Boyko, 2021; Paisey et al., 2017), Diabetic foot ulceration is a condition which has significant overlap with CLTI. It could therefore be inferred that a similar service for CLTI patients would also confer the same benefits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients seen and assessed in the CLTI clinic
排除标准
- •Patients without a confirmed diagnosis of CLTI
- •Patients with chronic venous insufficiency
- •Patients with diabetic foot infection
- •Patients with significant cognitive impairment such that they are unable to answer the questions
结局指标
主要结局
EuroQoL-5D Visual Acuity Scale (VAS) Score
时间窗: Baseline - 6-12 weeks - 1-year
The EuroQoL-5D is comprised of 2 parts, and the primary outcome involve scrutiny of the Visual Acuity Scale (VAS) represents a scale from 0 to 100 on which patients can report their own quality of life (0 the worst, 100 the best). The score is an integer and is measured again at 6-12 weeks, and again at 1-year post-initial assessment
次要结局
- EuroQoL-5D Movement(At baseline and 1-year)
- EuroQoL-5D Self Care(Baseline and 1-year)
- EuroQoL 5-D Usual Activities(Baseline and 1-year)
- EuroQoL 5-D Pain(Baseline and 1-year)
- EuroQoL 5-D Anxiety and/or Depression(Baseline and 1-year)