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CompletedNCT05659004Updated Aug 24, 2023

Referrals for CLTI: Qualitative Study

An observational study in Chronic Limb Threatening Ischemia, sponsored by University of Hull. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2023-08-24.

Sponsored by University of Hull · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
20
Ages
18 Years to 120 Years
Sex
All
01

Study summary

The goal of this qualitative study is to explore the experiences of patients who have been diagnosed with chronic limb-threatening ischaemia (CLTI). The main questions it aims to answer are:

  • What are the perceptions and experiences of patients between first symptom of CLTI and vascular surgery assessment
  • What is important to patients during this process.

Participants will be interviewed and their words analysed using reflexive thematic analysis.

Read the detailed description

There are delays at every stage of the patient journey from developing chronic limb-threatening ischaemia (CLTI) to treatment, associated with poorer outcomes for patients. There is currently limited national and international guidance on how and when to refer patients with suspected CLTI to specialist vascular surgery services. The use of qualitative interviews will allow us explore perceptions and experiences of patients with CLTI being referred to vascular surgery services, and identify possible ways to improve the process via interviews. This study will provide novel information on patient experience, and together with other work provide a framework for improvement of the referral process for CLTI.

02

Conditions studied

  • Chronic Limb Threatening Ischemia
03

In context

Chronic Limb-Threatening Ischemia

343 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 70 are open to participants now.

This study's enrollment of 20 is below the median of 123 across 98 observational studies indexed under Chronic Limb-Threatening Ischemia.

Browse Chronic Limb-Threatening Ischemia studies →

Lead sponsor

University of Hull is the lead sponsor of 33 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with chronic limb-threatening ischaemia in the last year

Inclusion criteria

  • CLTI diagnosed in the last year

Exclusion criteria

Exclusion Criteria:

  • Lacking capacity to consent to interview
  • Potential to be violent
  • Cognitive impairment
  • Non-English speaking
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • All participants

    1 qualitative interview

    Behavioral: Qualitative interview

Interventions

  • BehavioralQualitative interview

    No intervention

06

What researchers measure

Primary outcomes

  1. Experiences and perceptions of patients on their journey to diagnosis of CLTI

    Exploring patient experience

    Time frame: To be conducted in 2023

Secondary outcomes

  1. Potential improvements the process from first symptom to diagnosis of CLTI

    Identifying targets for improvement work

    Time frame: To be conducted in 2023

07

Study locations

2 sites
  • Cambridge University Hospitals NHS Trust
    Cambridge, Cambd CB2 0QQ, United Kingdom
  • Mid Yorkshire Hospitals NHS Trust
    Wakefield, Yorkshire WF1 4DG, United Kingdom
08

References and documents

Individual participant data

Plan to share: No — There is no plan; data will not be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05659004
Lead sponsor
University of Hull
Collaborators
The Royal College of Surgeons of England
Responsible party
Sponsor
First posted
Dec 21, 2022
Start date
Jan 10, 2023
Primary completion
Jul 7, 2023
Completion
Jul 7, 2023
Last update
Aug 24, 2023

Study contacts

Ian Chetter, MD
study director · University of Hull

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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