Trial Outcomes & Findings for Can a Dedicated Chronic Limb-threatening Ischaemia (CLTI) Clinic Improve Patient Self-reported Quality of Life (NCT NCT05613907)
NCT ID: NCT05613907
Last Updated: 2025-02-14
Results Overview
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
Recruitment status
COMPLETED
Target enrollment
30 participants
Primary outcome timeframe
Baseline - 6-12 weeks - 1-year
Results posted on
2025-02-14
Participant Flow
Participant milestones
| Measure |
CLTI Clinic
This group comprises patients who have been referred into the CLTI clinic service prior to their first assessment. These patients will be given a structured outcome questionnaire like the EuroQoL 5D questionnaire that asks them to describe their symptoms.
Whether they have revascularisation surgery or not, they are provided with a further EuroQoL 5-D questionnaire at 6-12 weeks and a final EuroQoL 5-D questionnaire at 1 year after their initial CLTI appointment
CLTI Clinic: This is a specialist clinic designed to assess and manage patients with CLTI.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
CLTI Clinic
This group comprises patients who have been referred into the CLTI clinic service prior to their first assessment. These patients will be given a structured outcome questionnaire like the EuroQoL 5D questionnaire that asks them to describe their symptoms.
Whether they have revascularisation surgery or not, they are provided with a further EuroQoL 5-D questionnaire at 6-12 weeks and a final EuroQoL 5-D questionnaire at 1 year after their initial CLTI appointment
CLTI Clinic: This is a specialist clinic designed to assess and manage patients with CLTI.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CLTI Clinic Patients
n=30 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=30 Participants
|
|
Age, Continuous
|
74 years
STANDARD_DEVIATION 11 • n=30 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline - 6-12 weeks - 1-yearThe 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
Outcome measures
| Measure |
CLTI Clinic Patients at Baseline
n=20 Participants
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 revascularisation or not.
These are the results obtained at baseline
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
|
CLTI Patients at 6-12 Weeks
n=20 Participants
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 revascularisation or not.
These are the results obtained between 6-12 weeks
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
|
CLTI Patients at 1-year
n=20 Participants
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 revascularisation or not.
These are the results obtained between 6-12 weeks
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
|
|---|---|---|---|
|
EuroQoL-5D Visual Acuity Scale (VAS) Score
|
47.55 score on a scale
Standard Deviation 25.45
|
69.15 score on a scale
Standard Deviation 14.16
|
65.35 score on a scale
Standard Deviation 15.86
|
SECONDARY outcome
Timeframe: At baseline and 1-yearThe 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.
Outcome measures
| Measure |
CLTI Clinic Patients at Baseline
n=20 Participants
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 revascularisation or not.
These are the results obtained at baseline
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
|
CLTI Patients at 6-12 Weeks
n=20 Participants
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 revascularisation or not.
These are the results obtained between 6-12 weeks
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
|
CLTI Patients at 1-year
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 revascularisation or not.
These are the results obtained between 6-12 weeks
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
|
|---|---|---|---|
|
EuroQoL-5D Movement
No problems with mobility
|
0 Participants
|
2 Participants
|
—
|
|
EuroQoL-5D Movement
Slight problems with mobility
|
2 Participants
|
4 Participants
|
—
|
|
EuroQoL-5D Movement
Moderate problems with mobility
|
7 Participants
|
6 Participants
|
—
|
|
EuroQoL-5D Movement
Severe problems with mobility
|
11 Participants
|
7 Participants
|
—
|
|
EuroQoL-5D Movement
Unable to mobilise
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1-yearThe 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.
Outcome measures
| Measure |
CLTI Clinic Patients at Baseline
n=20 Participants
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 revascularisation or not.
These are the results obtained at baseline
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
|
CLTI Patients at 6-12 Weeks
n=20 Participants
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 revascularisation or not.
These are the results obtained between 6-12 weeks
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
|
CLTI Patients at 1-year
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 revascularisation or not.
These are the results obtained between 6-12 weeks
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
|
|---|---|---|---|
|
EuroQoL-5D Self Care
No problems with self-care
|
8 Participants
|
9 Participants
|
—
|
|
EuroQoL-5D Self Care
Slight problems with self-care
|
4 Participants
|
4 Participants
|
—
|
|
EuroQoL-5D Self Care
Moderate problems with self-care
|
4 Participants
|
4 Participants
|
—
|
|
EuroQoL-5D Self Care
Severe problems with self-care
|
4 Participants
|
2 Participants
|
—
|
|
EuroQoL-5D Self Care
Unable to care for self
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1-yearThe 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.
Outcome measures
| Measure |
CLTI Clinic Patients at Baseline
n=20 Participants
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 revascularisation or not.
These are the results obtained at baseline
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
|
CLTI Patients at 6-12 Weeks
n=20 Participants
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 revascularisation or not.
These are the results obtained between 6-12 weeks
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
|
CLTI Patients at 1-year
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 revascularisation or not.
These are the results obtained between 6-12 weeks
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
|
|---|---|---|---|
|
EuroQoL 5-D Usual Activities
No problems performing usual activities
|
2 Participants
|
6 Participants
|
—
|
|
EuroQoL 5-D Usual Activities
Slight problems performing usual activities
|
4 Participants
|
5 Participants
|
—
|
|
EuroQoL 5-D Usual Activities
Moderate problems with performing usual activities
|
6 Participants
|
7 Participants
|
—
|
|
EuroQoL 5-D Usual Activities
Severe problems with performing usual activities
|
6 Participants
|
0 Participants
|
—
|
|
EuroQoL 5-D Usual Activities
I am unable to perform my usual activities
|
2 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1-yearThe 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.
Outcome measures
| Measure |
CLTI Clinic Patients at Baseline
n=20 Participants
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 revascularisation or not.
These are the results obtained at baseline
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
|
CLTI Patients at 6-12 Weeks
n=20 Participants
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 revascularisation or not.
These are the results obtained between 6-12 weeks
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
|
CLTI Patients at 1-year
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 revascularisation or not.
These are the results obtained between 6-12 weeks
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
|
|---|---|---|---|
|
EuroQoL 5-D Pain
No pain
|
1 Participants
|
9 Participants
|
—
|
|
EuroQoL 5-D Pain
Mild pain
|
2 Participants
|
4 Participants
|
—
|
|
EuroQoL 5-D Pain
Moderate pain
|
6 Participants
|
3 Participants
|
—
|
|
EuroQoL 5-D Pain
Severe pain
|
10 Participants
|
3 Participants
|
—
|
|
EuroQoL 5-D Pain
Extreme pain
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1-yearThe 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.
Outcome measures
| Measure |
CLTI Clinic Patients at Baseline
n=20 Participants
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 revascularisation or not.
These are the results obtained at baseline
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
|
CLTI Patients at 6-12 Weeks
n=20 Participants
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 revascularisation or not.
These are the results obtained between 6-12 weeks
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
|
CLTI Patients at 1-year
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 revascularisation or not.
These are the results obtained between 6-12 weeks
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
|
|---|---|---|---|
|
EuroQoL 5-D Anxiety and/or Depression
Moderate anxiety and/or depression
|
6 Participants
|
9 Participants
|
—
|
|
EuroQoL 5-D Anxiety and/or Depression
Severe anxiety and/or depression
|
3 Participants
|
0 Participants
|
—
|
|
EuroQoL 5-D Anxiety and/or Depression
Extreme anxiety and/or depression
|
0 Participants
|
0 Participants
|
—
|
|
EuroQoL 5-D Anxiety and/or Depression
No anxiety and/or depression
|
5 Participants
|
10 Participants
|
—
|
|
EuroQoL 5-D Anxiety and/or Depression
Slight anxiety and/or depression
|
6 Participants
|
1 Participants
|
—
|
POST_HOC outcome
Timeframe: Baseline - 6-12 weeks - 1-yearThe 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.
Outcome measures
| Measure |
CLTI Clinic Patients at Baseline
n=13 Participants
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 revascularisation or not.
These are the results obtained at baseline
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
|
CLTI Patients at 6-12 Weeks
n=13 Participants
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 revascularisation or not.
These are the results obtained between 6-12 weeks
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
|
CLTI Patients at 1-year
n=13 Participants
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 revascularisation or not.
These are the results obtained between 6-12 weeks
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
|
|---|---|---|---|
|
Revascularised EuroQoL 5-D VAS Score
|
39.85 score on a scale
Standard Deviation 27.525
|
66.69 score on a scale
Standard Deviation 15.206
|
67.46 score on a scale
Standard Deviation 16.008
|
POST_HOC outcome
Timeframe: Baseline - 6-12 weeks - 1-yearThe 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.
Outcome measures
| Measure |
CLTI Clinic Patients at Baseline
n=7 Participants
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 revascularisation or not.
These are the results obtained at baseline
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
|
CLTI Patients at 6-12 Weeks
n=7 Participants
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 revascularisation or not.
These are the results obtained between 6-12 weeks
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
|
CLTI Patients at 1-year
n=7 Participants
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 revascularisation or not.
These are the results obtained between 6-12 weeks
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
|
|---|---|---|---|
|
Non-operative EuroQoL 5-D VAS Score
|
58.83 score on a scale
Standard Deviation 12.954
|
73.71 score on a scale
Standard Deviation 11.615
|
61.43 score on a scale
Standard Deviation 15.999
|
Adverse Events
CLTI Clinic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place