Clinical trial NCT05613907: Can a Dedicated Chronic Limb-threatening Ischaemia (CLTI) Clinic Improve Patient Self-reported Quality of Life
Official title: Can a Dedicated Chronic Limb-threatening Ischaemia (CLTI) Clinic Improve Patient Self
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Limb Threatening Ischemia
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is made up of opportunistic patients obtained from the CLTI clinic attendance register. They have been referred to the service either because they have a confirmed diagnosis of CLTI and need further management or the disease is suspected. Patients who do not have CLTI will be excluded as will those who do not have the ability to answer questions about their perceived quality of life

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.

Eligibility criteria: 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

Primary outcomes:
measure: EuroQoL-5D Visual Acuity Scale (VAS) Score
timeFrame: Baseline - 6-12 weeks - 1-year
Secondary outcomes:
measure: EuroQoL-5D Movement
timeFrame: At baseline and 1-year
measure: EuroQoL-5D Self Care
timeFrame: Baseline and 1-year
measure: EuroQoL 5-D Usual Activities
timeFrame: Baseline and 1-year
measure: EuroQoL 5-D Pain
timeFrame: Baseline and 1-year
measure: EuroQoL 5-D Anxiety and/or Depression
timeFrame: Baseline and 1-year
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
state: West Yorkshire
Study officials:
affiliation: Leeds Vascular Institute, Leeds General Infirmary, Great George Street, Leeds, West Yorkshire, LS1 3EX, UK
name: Assad Khan, BMBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Li Q, Birmpili P, Johal AS, Waton S, Pherwani AD, Boyle JR, Cromwell DA. Delays to revascularization for patients with chronic limb-threatening ischaemia. Br J Surg. 2022 Jul 15;109(8):717-726. doi: 10.1093/bjs/znac109.
citation: Khan A, Hughes M, Ting M, Riding G, Simpson J, Egun A, Banihani M. A 'hot clinic' for cold limbs: the benefit of urgent clinics for patients with critical limb ischaemia. Ann R Coll Surg Engl. 2020 Jul;102(6):412-417. doi: 10.1308/rcsann.2020.0068. Epub 2020 Apr 20.
citation: Nickinson ATO, Dimitrova J, Houghton JSM, Rate L, Dubkova S, Lines H, Gray LJ, Nduwayo S, Payne TJ, Sayers RD, Davies RSM. Does the Introduction of a Vascular Limb Salvage Service Improve One Year Amputation Outcomes for Patients with Chronic Limb-Threatening Ischaemia? Eur J Vasc Endovasc Surg. 2021 Apr;61(4):612-619. doi: 10.1016/j.ejvs.2020.12.007. Epub 2021 Feb 12.