Can a Dedicated Chronic Limb-threatening Ischaemia (CLTI) Clinic Improve Patient Self-reported Quality of Life

Study Overview
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Brief Summary
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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.

Detailed Description
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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. At the Leeds Vascular Institute, we have implemented a dedicated CLTI clinic to assess and manage patients with the condition. Whilst there is limited evidence that these rapid access clinics can facilitate review and management of the condition, thereby successfully preventing major amputation in CLTI patients, the results are typically from single centre data series (Khan et al., 2020; Nickinson et al., 2021). There is a paucity of evidence evaluating patient opinions of this type of service and non that demonstrate any impact on their quality of life.

Official Title
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Can a Dedicated Chronic Limb-threatening Ischaemia (CLTI) Clinic Improve Patient Self

Conditions
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Chronic Limb Threatening Ischemia

Intervention / Treatment
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* Other: CLTI Clinic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients seen and assessed in the CLTI clinic Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-intervention<br>This group comprises patients who have been referred into the CLTI clinic service prior to their first assessment. These patients will be given a structured outcome questionnaire like the EuroQoL 5D questionnaire that asks them to describe their symptoms | Other: CLTI Clinic<br>* This is a specialist clinic designed to assess and manage patients with CLTI.<br>|
| Post-intervention<br>This group comprises patients from the pre-intervention group who have undergone a revascularisation procedure. These patients will be given the same structured questionnaire to complete post procedurally. They will also be invited to complete the same questionnaire at 12 months post revascularisation | Other: CLTI Clinic<br>* This is a specialist clinic designed to assess and manage patients with CLTI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistically significant change in self-reported quality of life | A statistically significant change in the self reported quality of life scores pre- and post-CLTI clinic assessment and management, using the EuroQoL-5D questionnaire. The EuroQoL 5-D questionnaire contains 4 questions which have 5 answers each ranging from no symptoms to severe symptoms. The final question is on a scale ranging from 0-100 where 0 is the worst possible response and 100 is the best possible response | 6 weeks and 12 months |