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

NCT05613907 | Completed Results

• 1 other identifier: VS22/151953
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Limb Threatening Ischemia

Outcome Measures

Primary Outcomes (1)

• EuroQoL-5D Visual Acuity Scale (VAS) Score

  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

  Baseline - 6-12 weeks - 1-year

Secondary Outcomes (5)

• EuroQoL-5D Movement

  At baseline and 1-year

• EuroQoL-5D Self Care

  Baseline and 1-year

• EuroQoL 5-D Usual Activities

  Baseline and 1-year

• EuroQoL 5-D Pain

  Baseline and 1-year

• EuroQoL 5-D Anxiety and/or Depression

  Baseline and 1-year

Study Arms (1)

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

Other: CLTI Clinic

Interventions

CLTI Clinic 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

CLTI clinic patients

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• All patients seen and assessed in the CLTI clinic

You may not qualify if:

• 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

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS1 3EX, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 33423910 BACKGROUND

• 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.

  PMID: 29023974 BACKGROUND

• 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.

  PMID: 35543274 RESULT

• 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.

  PMID: 32306742 RESULT

• 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.

  PMID: 33583708 RESULT

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Limitations and Caveats

Low recruitment numbers. This is multifactorial. * Some patients feel unable to meaningfully answer the questions or engage with technology used to complete the questionnaire * Some have mild memory impairment, and may struggle answering questions or remembering that they are enrolled. * Some patients report felt overwhelmed by the diagnosis and management and either declined to participate or withdrew midway. * CLTI is a condition with high mortality, and some patients did not survive.

Results Point of Contact

• Title: Dr Assad Khan
• Organization: Leeds Vascular Institute

assad.khan3@nhs.net

0113

Study Officials

• Assad Khan, BMBS

  Leeds Vascular Institute, Leeds General Infirmary, Great George Street, Leeds, West Yorkshire, LS1 3EX, UK

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: November 17, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 14, 2025
• Results First Posted: February 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)