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

Completed

Conditions: Chronic Limb Threatening Ischemia

Interventions: Other: CLTI Clinic

Registration Number: NCT05613907

Lead Sponsor: The Leeds Teaching Hospitals NHS Trust

Brief Summary: 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: 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 experience of this type of service. Therefore, the purpose of this study is to collect patient-reported outcome measure data at serial points in time, to determine whether a dedicated CLTI clinic can provide a significant and sustained improvement in self-reported quality of life for patients who utilise the service.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-intervention	CLTI Clinic	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
Post-intervention	CLTI Clinic	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

Primary Outcome Measures

Name	Time	Method
EuroQoL-5D Visual Acuity Scale (VAS) Score	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

Secondary Outcome Measures

Name	Time	Method
EuroQoL-5D Movement	At baseline and 1-year	The EuroQol-5D is comprised of 2 parts, and the secondary outcomes involve scrutiny of the separate QoL domains that give rise to the 5D in the name, which are: mobility; self-care; usual activities; pain; anxiety and depression. Patients self-report their own experiences on a 5-point scale. We are comparing pre- and post-intervention levels of the above.
EuroQoL-5D Self Care	Baseline and 1-year	The EuroQol-5D is comprised of 2 parts, and the secondary outcomes involve scrutiny of the separate QoL domains that give rise to the 5D in the name, which are: mobility; self-care; usual activities; pain; anxiety and depression. Patients self-report their own experiences on a 5-point scale. We are comparing pre- and post-intervention levels of the above.
EuroQoL 5-D Usual Activities	Baseline and 1-year	The EuroQol-5D is comprised of 2 parts, and the secondary outcomes involve scrutiny of the separate QoL domains that give rise to the 5D in the name, which are: mobility; self-care; usual activities; pain; anxiety and depression. Patients self-report their own experiences on a 5-point scale. We are comparing pre- and post-intervention levels of the above.
EuroQoL 5-D Pain	Baseline and 1-year	The EuroQol-5D is comprised of 2 parts, and the secondary outcomes involve scrutiny of the separate QoL domains that give rise to the 5D in the name, which are: mobility; self-care; usual activities; pain; anxiety and depression. Patients self-report their own experiences on a 5-point scale. We are comparing pre- and post-intervention levels of the above.
EuroQoL 5-D Anxiety and/or Depression	Baseline and 1-year	The EuroQol-5D is comprised of 2 parts, and the secondary outcomes involve scrutiny of the separate QoL domains that give rise to the 5D in the name, which are: mobility; self-care; usual activities; pain; anxiety and depression. Patients self-report their own experiences on a 5-point scale. We are comparing pre- and post-intervention levels of the above.