Chronic Limb Threatening IschemiaNCT05659004
Referrals for CLTI: Qualitative Study
An observational study of Chronic Limb Threatening Ischemia, run by University of Hull at 2 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Chronic Limb Threatening Ischemia
- What is being tested?
- Qualitative interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 10 Jan 2023to 7 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with chronic limb-threatening ischaemia in the last year
Who may be able to join
- CLTI diagnosed in the last year
Who cannot join
- Lacking capacity to consent to interview
- Potential to be violent
- Cognitive impairment
- Non-English speaking
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Cambridge University Hospitals NHS Trust
Cambridge, Cambd, CB2 0QQ
Mid Yorkshire Hospitals NHS Trust
Wakefield, Yorkshire, WF1 4DG
About this study
Official title: The Experiences of Patients With Chronic Limb-threatening Ischaemia From First Symptom to Vascular Surgery Assessment: a Qualitative Study
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.
- Conditions
- Chronic Limb Threatening Ischemia
- Being tested
- Qualitative interview
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative interviewBehavioural
No intervention
| Study group | Role | What they receive |
|---|---|---|
| All participants | 1 qualitative interview Receives: Behavioral: Qualitative interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiences and perceptions of patients on their journey to diagnosis of CLTI
Exploring patient experience
Measured: To be conducted in 2023
Secondary outcomes (1)
Potential improvements the process from first symptom to diagnosis of CLTI
Identifying targets for improvement work
Measured: To be conducted in 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start10 Jan 2023
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Limb Threatening IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal College of Surgeons of England
- Responsible party
- Sponsor
- Investigators
- Ian Chetter, MD, Study director, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659004
- Sponsor's protocol ID
- 321794
- Status last verified
- Aug 2023
- First submitted
- 12 Dec 2022
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan; data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Experiences of Patients With Chronic Limb-threatening Ischaemia From First Symptom to Vascular Surgery Assessment: a Qualitative Study
- ClinicalTrials.gov ID
- NCT05659004
- Acronym / sponsor ID
- 321794
- Conditions
- Chronic Limb Threatening Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of HullUniversity, hospital or other
- Collaborators
- The Royal College of Surgeons of England
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Behavioral: Qualitative interview1 qualitative interview |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with chronic limb-threatening ischaemia in the last year
Key inclusion criteria (1 listed)
- CLTI diagnosed in the last year
Key exclusion criteria (4 listed)
- Lacking capacity to consent to interview
- Potential to be violent
- Cognitive impairment
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative interviewNo intervention | Behavioural | All participants |
Primary outcome
Experiences and perceptions of patients on their journey to diagnosis of CLTI
Time frame: To be conducted in 2023
Exploring patient experience
1 secondary outcome
Potential improvements the process from first symptom to diagnosis of CLTI
Time frame: To be conducted in 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: No. There is no plan; data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Chetter, MD study director
University of Hull
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Limb Threatening Ischemia, run by University of Hull at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiences and perceptions of patients on their journey to diagnosis of CLTI (time frame: To be conducted in 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.