Can a Dedicated Chronic Limb-threatening Ischaemia (CLTI) Clinic Improve Patient Self-reported Quality of Life
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 opinions of this type of service and non that demonstrate any impact on their quality of life.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pre-intervention 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
This is a specialist clinic designed to assess and manage patients with CLTI.
|
| Post-intervention 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
This is a specialist clinic designed to assess and manage patients with CLTI.
|
Outcome Measures
Primary Outcome Measures
- Statistically significant change in self-reported quality of life [6 weeks and 12 months]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
- All patients seen and assessed in the CLTI clinic
Exclusion Criteria:
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Patients without a confirmed diagnosis of CLTI
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Patients with chronic venous insufficiency
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Patients with diabetic foot infection
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Patients with significant cognitive impairment such that they are unable to answer the questions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Leeds Teaching Hospitals NHS Trust | Leeds | West Yorkshire | United Kingdom | LS1 3EX |
Sponsors and Collaborators
- The Leeds Teaching Hospitals NHS Trust
Investigators
- Principal Investigator: Assad Khan, BMBS, Leeds Vascular Institute, Leeds General Infirmary, Great George Street, Leeds, West Yorkshire, LS1 3EX, UK
Study Documents (Full-Text)
None provided.More Information
Publications
- Monteiro-Soares M, Vale-Lima J, Martiniano J, Pinheiro-Torres S, Dias V, Boyko EJ. A systematic review with meta-analysis of the impact of access and quality of diabetic foot care delivery in preventing lower extremity amputation. J Diabetes Complications. 2021 Apr;35(4):107837. doi: 10.1016/j.jdiacomp.2020.107837. Epub 2020 Dec 31.
- Paisey RB, Abbott A, Levenson R, Harrington A, Browne D, Moore J, Bamford M, Roe M; South-West Cardiovascular Strategic Clinical Network peer diabetic foot service review team. Diabetes-related major lower limb amputation incidence is strongly related to diabetic foot service provision and improves with enhancement of services: peer review of the South-West of England. Diabet Med. 2018 Jan;35(1):53-62. doi: 10.1111/dme.13512. Epub 2017 Oct 11. Erratum In: Diabet Med. 2018 Mar;35(3):394.
- VS22/151953