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
Group
Value
95% CI
CLTI Clinic Patients at Baseline
47.55
± 25.45
CLTI Patients at 6-12 Weeks
69.15
± 14.16
CLTI Patients at 1-year
65.35
± 15.86
EuroQoL-5D MovementSecondary· 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.
Group
Value
95% CI
CLTI Clinic Patients at Baseline
0
CLTI Patients at 1 Year
2
CLTI Clinic Patients at Baseline
2
CLTI Patients at 1 Year
4
CLTI Clinic Patients at Baseline
7
CLTI Patients at 1 Year
6
CLTI Clinic Patients at Baseline
11
CLTI Patients at 1 Year
7
EuroQoL-5D Self CareSecondary· 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.
Group
Value
95% CI
CLTI Clinic Patients at Baseline
8
CLTI Patients at 1 Year
9
CLTI Clinic Patients at Baseline
4
CLTI Patients at 1 Year
4
CLTI Clinic Patients at Baseline
4
CLTI Patients at 1 Year
4
CLTI Clinic Patients at Baseline
4
CLTI Patients at 1 Year
2
EuroQoL 5-D Usual ActivitiesSecondary· 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.
Group
Value
95% CI
CLTI Clinic Patients at Baseline
2
CLTI Patients at 1 Year
6
CLTI Clinic Patients at Baseline
4
CLTI Patients at 1 Year
5
CLTI Clinic Patients at Baseline
6
CLTI Patients at 1 Year
7
CLTI Clinic Patients at Baseline
6
CLTI Patients at 1 Year
0
EuroQoL 5-D PainSecondary· 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.
Group
Value
95% CI
CLTI Clinic Patients at Baseline
1
CLTI Patients at 1 Year
9
CLTI Clinic Patients at Baseline
2
CLTI Patients at 1 Year
4
CLTI Clinic Patients at Baseline
6
CLTI Patients at 1 Year
3
CLTI Clinic Patients at Baseline
10
CLTI Patients at 1 Year
3
EuroQoL 5-D Anxiety and/or DepressionSecondary· 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.
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.
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.
Group
Value
95% CI
CLTI Clinic Patients at Baseline
58.83
± 12.954
CLTI Patients at 6-12 Weeks
73.71
± 11.615
CLTI Patients at 1-year
61.43
± 15.999
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by The Leeds Teaching Hospitals NHS Trust
Last refreshed: 14 February 2025
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