Chronic Limb Threatening Ischemia
Conditions
Brief 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. 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.
Interventions
OTHERCLTI Clinic
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
Sponsors
The Leeds Teaching Hospitals NHS Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 105 Years
Healthy volunteers
No
Inclusion criteria
* All patients seen and assessed in the CLTI clinic
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EuroQoL-5D Visual Acuity Scale (VAS) Score | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuroQoL-5D Movement | At baseline and 1-year | 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. |
| EuroQoL-5D Self Care | Baseline and 1-year | 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. |
| EuroQoL 5-D Usual Activities | Baseline and 1-year | 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. |
| EuroQoL 5-D Pain | Baseline and 1-year | 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. |
| EuroQoL 5-D Anxiety and/or Depression | Baseline and 1-year | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
CLTI Clinic: 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 | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | CLTI Clinic Patients | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 26 Participants | — |
| Age, Categorical Between 18 and 65 years | 4 Participants | — |
| Age, Continuous | 74 years STANDARD_DEVIATION 11 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 22 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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
Time frame: Baseline - 6-12 weeks - 1-year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLTI Clinic Patients at Baseline | EuroQoL-5D Visual Acuity Scale (VAS) Score | 47.55 score on a scale | Standard Deviation 25.45 |
| CLTI Patients at 6-12 Weeks | EuroQoL-5D Visual Acuity Scale (VAS) Score | 69.15 score on a scale | Standard Deviation 14.16 |
| CLTI Patients at 1-year | EuroQoL-5D Visual Acuity Scale (VAS) Score | 65.35 score on a scale | Standard Deviation 15.86 |
p-value: 0.00595% CI: [-37.05, -6.15]ANOVA
p-value: 0.0495% CI: [-34.895, -0.705]ANOVA
p-value: 0.9495% CI: [-5.829, 13.429]ANOVA
Secondary
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.
Time frame: Baseline and 1-year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CLTI Clinic Patients at Baseline | EuroQoL 5-D Anxiety and/or Depression | Slight anxiety and/or depression | 6 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL 5-D Anxiety and/or Depression | Severe anxiety and/or depression | 3 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL 5-D Anxiety and/or Depression | Moderate anxiety and/or depression | 6 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL 5-D Anxiety and/or Depression | Extreme anxiety and/or depression | 0 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL 5-D Anxiety and/or Depression | No anxiety and/or depression | 5 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL 5-D Anxiety and/or Depression | Extreme anxiety and/or depression | 0 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL 5-D Anxiety and/or Depression | No anxiety and/or depression | 10 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL 5-D Anxiety and/or Depression | Slight anxiety and/or depression | 1 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL 5-D Anxiety and/or Depression | Moderate anxiety and/or depression | 9 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL 5-D Anxiety and/or Depression | Severe anxiety and/or depression | 0 Participants |
p-value: 0.19Wilcoxon signed rank
Secondary
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.
Time frame: At baseline and 1-year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CLTI Clinic Patients at Baseline | EuroQoL-5D Movement | Slight problems with mobility | 2 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL-5D Movement | Severe problems with mobility | 11 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL-5D Movement | Moderate problems with mobility | 7 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL-5D Movement | Unable to mobilise | 0 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL-5D Movement | No problems with mobility | 0 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL-5D Movement | Unable to mobilise | 1 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL-5D Movement | No problems with mobility | 2 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL-5D Movement | Slight problems with mobility | 4 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL-5D Movement | Moderate problems with mobility | 6 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL-5D Movement | Severe problems with mobility | 7 Participants |
Comparison: The null hypothesis is that there will be no significant difference in the EuroQol 5-D domains at 1 year compared to baseline.p-value: 0.388Wilcoxon Signed Ranks
Secondary
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.
Time frame: Baseline and 1-year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CLTI Clinic Patients at Baseline | EuroQoL 5-D Pain | Mild pain | 2 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL 5-D Pain | Severe pain | 10 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL 5-D Pain | Moderate pain | 6 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL 5-D Pain | Extreme pain | 1 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL 5-D Pain | No pain | 1 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL 5-D Pain | Extreme pain | 1 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL 5-D Pain | No pain | 9 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL 5-D Pain | Mild pain | 4 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL 5-D Pain | Moderate pain | 3 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL 5-D Pain | Severe pain | 3 Participants |
p-value: 0.018Wilcoxon signed rank
Secondary
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.
Time frame: Baseline and 1-year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CLTI Clinic Patients at Baseline | EuroQoL-5D Self Care | Moderate problems with self-care | 4 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL-5D Self Care | Unable to care for self | 0 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL-5D Self Care | No problems with self-care | 8 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL-5D Self Care | Severe problems with self-care | 4 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL-5D Self Care | Slight problems with self-care | 4 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL-5D Self Care | Unable to care for self | 1 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL-5D Self Care | Slight problems with self-care | 4 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL-5D Self Care | Moderate problems with self-care | 4 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL-5D Self Care | Severe problems with self-care | 2 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL-5D Self Care | No problems with self-care | 9 Participants |
Comparison: The null hypothesis is that there will be no statistical difference in patient self-reported ability to perform basic self-carep-value: 0.974Wilcoxon signed rank
Secondary
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.
Time frame: Baseline and 1-year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CLTI Clinic Patients at Baseline | EuroQoL 5-D Usual Activities | Slight problems performing usual activities | 4 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL 5-D Usual Activities | Severe problems with performing usual activities | 6 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL 5-D Usual Activities | Moderate problems with performing usual activities | 6 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL 5-D Usual Activities | I am unable to perform my usual activities | 2 Participants |
| CLTI Clinic Patients at Baseline | EuroQoL 5-D Usual Activities | No problems performing usual activities | 2 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL 5-D Usual Activities | I am unable to perform my usual activities | 2 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL 5-D Usual Activities | No problems performing usual activities | 6 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL 5-D Usual Activities | Slight problems performing usual activities | 5 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL 5-D Usual Activities | Moderate problems with performing usual activities | 7 Participants |
| CLTI Patients at 6-12 Weeks | EuroQoL 5-D Usual Activities | Severe problems with performing usual activities | 0 Participants |
Comparison: The null hypothesis is no improvement in ability to perform usual activities at 1 year.p-value: 0.118Wilcoxon signed rank
Post Hoc
Non-operative EuroQoL 5-D 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. This sub-group analysis is of patients who did not undergo revascularisation procedures.
Time frame: Baseline - 6-12 weeks - 1-year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLTI Clinic Patients at Baseline | Non-operative EuroQoL 5-D VAS Score | 58.83 score on a scale | Standard Deviation 12.954 |
| CLTI Patients at 6-12 Weeks | Non-operative EuroQoL 5-D VAS Score | 73.71 score on a scale | Standard Deviation 11.615 |
| CLTI Patients at 1-year | Non-operative EuroQoL 5-D VAS Score | 61.43 score on a scale | Standard Deviation 15.999 |
p-value: 0.04895% CI: [-37.05, -6.15]ANOVA
p-value: 195% CI: [-12.893, 13.751]ANOVA
p-value: 0.16395% CI: [-4.762, 29.333]ANOVA
Post Hoc
Revascularised EuroQoL 5-D 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. This sub-group analysis is of patients who underwent revascularisation procedures.
Time frame: Baseline - 6-12 weeks - 1-year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLTI Clinic Patients at Baseline | Revascularised EuroQoL 5-D VAS Score | 39.85 score on a scale | Standard Deviation 27.525 |
| CLTI Patients at 6-12 Weeks | Revascularised EuroQoL 5-D VAS Score | 66.69 score on a scale | Standard Deviation 15.206 |
| CLTI Patients at 1-year | Revascularised EuroQoL 5-D VAS Score | 67.46 score on a scale | Standard Deviation 16.008 |
p-value: 0.02795% CI: [-50.762, -2.39]ANOVA
p-value: 0.02495% CI: [-51.837, -3.394]ANOVA
p-value: 195% CI: [-13.374, 11.836]ANOVA