NCT05659004

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

January 10, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

December 12, 2022

Last Update Submit

August 23, 2023

Conditions

Chronic Limb Threatening Ischemia

Outcome Measures

Primary Outcomes (1)

  • Experiences and perceptions of patients on their journey to diagnosis of CLTI

    Exploring patient experience

    To be conducted in 2023

Secondary Outcomes (1)

  • Potential improvements the process from first symptom to diagnosis of CLTI

    To be conducted in 2023

Study Arms (1)

All participants

1 qualitative interview

Behavioral: Qualitative interview

Interventions

Qualitative interviewBEHAVIORAL

No intervention

All participants

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \- CLTI diagnosed in the last year

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cambridge University Hospitals NHS Trust

Cambridge, Cambd, CB2 0QQ, United Kingdom

Location

Mid Yorkshire Hospitals NHS Trust

Wakefield, Yorkshire, WF1 4DG, United Kingdom

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Officials

  • Ian Chetter, MD

    University of Hull

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2022

First Posted

December 21, 2022

Study Start

January 10, 2023

Primary Completion

July 7, 2023

Study Completion

July 7, 2023

Last Updated

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

There is no plan; data will not be shared.

Locations

GB(2)