Chronic Limb Threatening IschemiaNCT05613907
Can a Dedicated Chronic Limb-threatening Ischaemia (CLTI) Clinic Improve Patient Self-reported Quality of Life
An observational study of Chronic Limb Threatening Ischemia, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Chronic Limb Threatening Ischemia
- What is being tested?
- CLTI Clinic
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Nov 2022to 1 Aug 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- All patients seen and assessed in the CLTI clinic
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS1 3EX
About this study
Official title: Can a Dedicated Chronic Limb-threatening Ischaemia (CLTI) Clinic Improve Patient Self
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.
Read the detailed description
Chronic limb-threatening ischaemia (CLTI) is the most severe form of peripheral arterial disease (PAD). It affects 1% of the population and its incidence is expected to rise. It is a condition where the circulation to one, or both limbs is inadequate. It requires investigation and may require surgery in order to improve the blood flow to the affected limb(s). Without improvement in circulation, ulcers and gangrene set in, and the only cure is a major limb amputation.
Vascular surgery units in the United Kingdom have undergone centralisation into regional networks over the last decade in order to consolidate vascular surgery into 'high volume centres' to provide high quality care and better outcomes for patients.
However, national analysis of the performance of units has demonstrated that only 50% of CLTI patients are revascularised within the 'deliberately-challenging timeline' issued by the Vascular Society of Great Britain and Ireland (Birmpili et al., 2021; Vascular Society of Great Britain and Ireland, 2019).
CLTI already comprises more than 50% of vascular unit workload and the prevalence of CLTI is expected to rise, further increasing the burden on vascular services (Fowkes et al., 2016; Vascular Society of Great Britain and Ireland, 2018, 2021).
There is ample evidence demonstrating a strong inverse correlation between the provision of specialist outpatient clinics in the assessment and management of diabetic foot ulcers and major lower limb amputation (Joret et al., 2019; M Kerr, Rayman, \& Jeffcoate, 2014; Marion Kerr, 2017; Monteiro-soares, Vale-lima, Martiniano, Dias, \& Boyko, 2021; Paisey et al., 2017), Diabetic foot ulceration is a condition which has significant overlap with CLTI. It could therefore be inferred that a similar service for CLTI patients would also confer the same benefits.
At the Leeds Vascular Institute, we have implemented a dedicated CLTI clinic to assess and manage patients with the condition. Whilst there is limited evidence that these rapid access clinics can facilitate review and management of the condition, thereby successfully preventing major amputation in CLTI patients, the results are typically from single centre data series (Khan et al., 2020; Nickinson et al., 2021).
There is a paucity of evidence evaluating patient experience of this type of service. Therefore, the purpose of this study is to collect patient-reported outcome measure data at serial points in time, to determine whether a dedicated CLTI clinic can provide a significant and sustained improvement in self-reported quality of life for patients who utilise the service.
- Conditions
- Chronic Limb Threatening Ischemia
- Being tested
- CLTI Clinic
- 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.
CLTI ClinicOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: CLTI Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline - 6-12 weeks - 1-year
Secondary outcomes (5)
EuroQoL-5D Movement
The EuroQol-5D is comprised of 2 parts, and the secondary outcomes involve scrutiny of the separate QoL domains that give rise to the 5D in the name, which are: mobility; self-care; usual activities; pain; anxiety and depression. Patients self-report their own experiences on a 5-point scale. We are comparing pre- and post-intervention levels of the above.
Measured: At baseline and 1-year
EuroQoL-5D Self Care
The EuroQol-5D is comprised of 2 parts, and the secondary outcomes involve scrutiny of the separate QoL domains that give rise to the 5D in the name, which are: mobility; self-care; usual activities; pain; anxiety and depression. Patients self-report their own experiences on a 5-point scale. We are comparing pre- and post-intervention levels of the above.
Measured: Baseline and 1-year
EuroQoL 5-D Usual Activities
The EuroQol-5D is comprised of 2 parts, and the secondary outcomes involve scrutiny of the separate QoL domains that give rise to the 5D in the name, which are: mobility; self-care; usual activities; pain; anxiety and depression. Patients self-report their own experiences on a 5-point scale. We are comparing pre- and post-intervention levels of the above.
Measured: Baseline and 1-year
EuroQoL 5-D Pain
The EuroQol-5D is comprised of 2 parts, and the secondary outcomes involve scrutiny of the separate QoL domains that give rise to the 5D in the name, which are: mobility; self-care; usual activities; pain; anxiety and depression. Patients self-report their own experiences on a 5-point scale. We are comparing pre- and post-intervention levels of the above.
Measured: Baseline and 1-year
EuroQoL 5-D Anxiety and/or Depression
The EuroQol-5D is comprised of 2 parts, and the secondary outcomes involve scrutiny of the separate QoL domains that give rise to the 5D in the name, which are: mobility; self-care; usual activities; pain; anxiety and depression. Patients self-report their own experiences on a 5-point scale. We are comparing pre- and post-intervention levels of the above.
Measured: Baseline and 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start17 Nov 2022
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Assad Khan, BMBS, Principal investigator, Leeds Vascular Institute, Leeds General Infirmary, Great George Street, Leeds, West Yorkshire, LS1 3EX, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613907
- Sponsor's protocol ID
- VS22/151953
- Status last verified
- Jan 2025
- First submitted
- 4 Nov 2022
- Last updated
- 14 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33423910Paisey 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.
PubMed 29023974Li 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.
PubMed 35543274Khan 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.
PubMed 32306742Nickinson 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.
PubMed 33583708
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Dedicated Chronic Limb-threatening Ischaemia (CLTI) Clinic Improve Patient Self
- ClinicalTrials.gov ID
- NCT05613907
- Acronym / sponsor ID
- VS22/151953
- Conditions
- Chronic Limb Threatening Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Posted 14 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic limb-threatening ischaemia (CLTI) is the most severe form of peripheral arterial disease (PAD). It affects 1% of the population and its incidence is expected to rise. It is a condition where the circulation to one, or both limbs is inadequate. It requires investigation and may require surgery in order to improve the blood flow to the affected limb(s). Without improvement in circulation, ulcers and gangrene set in, and the only cure is a major limb amputation.
Vascular surgery units in the United Kingdom have undergone centralisation into regional networks over the last decade in order to consolidate vascular surgery into 'high volume centres' to provide high quality care and better outcomes for patients.
However, national analysis of the performance of units has demonstrated that only 50% of CLTI patients are revascularised within the 'deliberately-challenging timeline' issued by the Vascular Society of Great Britain and Ireland (Birmpili et al., 2021; Vascular Society of Great Britain and Ireland, 2019).
CLTI already comprises more than 50% of vascular unit workload and the prevalence of CLTI is expected to rise, further increasing the burden on vascular services (Fowkes et al., 2016; Vascular Society of Great Britain and Ireland, 2018, 2021).
There is ample evidence demonstrating a strong inverse correlation between the provision of specialist outpatient clinics in the assessment and management of diabetic foot ulcers and major lower limb amputation (Joret et al., 2019; M Kerr, Rayman, \& Jeffcoate, 2014; Marion Kerr, 2017; Monteiro-soares, Vale-lima, Martiniano, Dias, \& Boyko, 2021; Paisey et al., 2017), Diabetic foot ulceration is a condition which has significant overlap with CLTI. It could therefore be inferred that a similar service for CLTI patients would also confer the same benefits.
At the Leeds Vascular Institute, we have implemented a dedicated CLTI clinic to assess and manage patients with the condition. Whilst there is limited evidence that these rapid access clinics can facilitate review and management of the condition, thereby successfully preventing major amputation in CLTI patients, the results are typically from single centre data series (Khan et al., 2020; Nickinson et al., 2021).
There is a paucity of evidence evaluating patient experience of this type of service. Therefore, the purpose of this study is to collect patient-reported outcome measure data at serial points in time, to determine whether a dedicated CLTI clinic can provide a significant and sustained improvement in self-reported quality of life for patients who utilise the service.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLTI clinic patients | – | Other: CLTI ClinicThis 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 |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All patients seen and assessed in the CLTI clinic
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| CLTI ClinicThis is a specialist clinic designed to assess and manage patients with CLTI. Patients are assessed and imaged, and undergo elective revascularization procedures if appropriate | Other | CLTI clinic patients |
Primary outcome
EuroQoL-5D Visual Acuity Scale (VAS) Score
Time frame: Baseline - 6-12 weeks - 1-year
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
5 secondary outcomes
EuroQoL-5D Movement
Time frame: At baseline and 1-year
EuroQoL-5D Self Care
Time frame: Baseline and 1-year
EuroQoL 5-D Usual Activities
Time frame: Baseline and 1-year
EuroQoL 5-D Pain
Time frame: Baseline and 1-year
EuroQoL 5-D Anxiety and/or Depression
Time frame: Baseline and 1-year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33423910Monteiro-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.
- Background: PubMed 29023974Paisey 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.
- Results publication: PubMed 35543274Li 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.
- Results publication: PubMed 32306742Khan 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.
- Results publication: PubMed 33583708Nickinson 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.
- Individual participant dataSharing planned: No
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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.
Assad Khan, BMBS principal investigator
Leeds Vascular Institute, Leeds General Infirmary, Great George Street, Leeds, West Yorkshire, LS1 3EX, UK
1 site 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 The Leeds Teaching Hospitals NHS Trust at 1 site 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 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 14 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
EuroQoL-5D Visual Acuity Scale (VAS) Score (time frame: Baseline - 6-12 weeks - 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05613907, which also lists 5 linked publications.
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 14 Feb 2025.