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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05659004
Other study ID # 321794
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 10, 2023
Est. completion date July 7, 2023

Study information

Verified date August 2023
Source University of Hull
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 7, 2023
Est. primary completion date July 7, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility Inclusion Criteria: - CLTI diagnosed in the last year Exclusion Criteria: - Lacking capacity to consent to interview - Potential to be violent - Cognitive impairment - Non-English speaking

Study Design


Related Conditions & MeSH terms

  • Chronic Limb Threatening Ischemia
  • Chronic Limb-Threatening Ischemia
  • Ischemia

Intervention

Behavioral:
Qualitative interview
No intervention

Locations

Country Name City State
United Kingdom Cambridge University Hospitals NHS Trust Cambridge Cambd
United Kingdom Mid Yorkshire Hospitals NHS Trust Wakefield Yorkshire

Sponsors (2)

Lead Sponsor Collaborator
University of Hull The Royal College of Surgeons of England

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Experiences and perceptions of patients on their journey to diagnosis of CLTI Exploring patient experience To be conducted in 2023
Secondary Potential improvements the process from first symptom to diagnosis of CLTI Identifying targets for improvement work To be conducted in 2023
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Enrolling by invitation NCT05786001 - Multimodal Noninvasive Assessment of Peripheral Circulation in Chronic Limb-threatening Ischemia