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

Chronic Limb Threatening Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05613907
• Other study ID #: VS22/151953
• Status: Not yet recruiting
• Start date: January 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: November 2022
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: Assad Khan, BMBS
• Phone: +447792391212
• Email: assad.khan3[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Limb Threatening Ischemia
• Ischemia

Intervention

Other:
• CLTI Clinic
This is a specialist clinic designed to assess and manage patients with CLTI.

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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 2 — View 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. — View 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. — View 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-Threate — View 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. Erratum in: Diabet Med. 2018 Mar;35(3):394. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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