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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-17

Study Completion Date

2024-08-01

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.

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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 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.

Conditions

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Chronic Limb Threatening Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CLTI clinic patients

This is a repeated measures study design. Eligible patients are opportunistically recruited into the study, and if successfully enrolled are given the EuroQoL 5-D to complete.

Whether they undergo a revascularization procedure or not, the EuroQol 5-D is administered again at 6-12 weeks and again at 1 year after their initial assessment

CLTI Clinic

Intervention Type OTHER

This is a specialist clinic designed to assess and manage patients with CLTI. Patients are assessed and imaged, and undergo elective revascularization procedures if appropriate

Interventions

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CLTI Clinic

This is a specialist clinic designed to assess and manage patients with CLTI. Patients are assessed and imaged, and undergo elective revascularization procedures if appropriate

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No