N/A
N=30
Can a Dedicated Chronic Limb-threatening Ischaemia (CLTI) Clinic Improve Patient Self-reported Quality of Life
Chronic Limb Threatening Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT05613907 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: EuroQoL-5D Visual Acuity Scale (VAS) Score — 47.55; 69.15; 65.35 score on a scale — p=0.005
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- CLTI Clinic (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Leeds Teaching Hospitals NHS Trust
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY EuroQoL-5D Visual Acuity Scale (VAS) Score |
47.55; 69.15; 65.35 | 0.005 sig |
| SECONDARY EuroQoL-5D Movement |
0; 2; 2; 4; 7; 6 | 0.388 |
| SECONDARY EuroQoL-5D Self Care |
8; 9; 4; 4; 4; 4 | 0.974 |
| SECONDARY EuroQoL 5-D Usual Activities |
2; 6; 4; 5; 6; 7 | 0.118 |
| SECONDARY EuroQoL 5-D Pain |
1; 9; 2; 4; 6; 3 | 0.018 sig |
| SECONDARY EuroQoL 5-D Anxiety and/or Depression |
5; 10; 6; 1; 6; 9 | 0.190 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05613907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.