Trial Outcomes & Findings for Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes (NCT NCT05009602)
NCT ID: NCT05009602
Last Updated: 2025-09-03
Results Overview
Diagnostic accuracy of the PAD-scan and other bedside tests will be compared to the results of a Magnetic resonance angiograph (MRA) or Computed tomography angiography (CTA) (reference test).
Recruitment status
COMPLETED
Target enrollment
604 participants
Primary outcome timeframe
6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.
Results posted on
2025-09-03
Participant Flow
Patients are assessed for eligibility and some are excluded as per eligibility criteria
Participant milestones
| Measure |
All Participants
Diagnostic Test: Toe Brachial Pressure Index (TBPI) TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.
Diagnostic Test: Ankle Brachial Pressure Index (ABPI) A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery.
Diagnostic Test: Exercise Ankle Brachial Pressure Index (ABPI) A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery, following the participant completing 50 consecutive repetitions of active dorsiflexion whilst standing.
Diagnostic Test: Audible handheld Doppler Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.
Diagnostic Test: Visual handheld Doppler Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.
Diagnostic Test: Podiatry Ankle Duplex scan (PAD-scan) Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.
To be used in 3 participating centers only.
|
|---|---|
|
Overall Study
STARTED
|
604
|
|
Overall Study
COMPLETED
|
536
|
|
Overall Study
NOT COMPLETED
|
68
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes
Baseline characteristics by cohort
| Measure |
All Participants
n=603 Participants
Diagnostic Test: Toe Brachial Pressure Index (TBPI) TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.
Diagnostic Test: Ankle Brachial Pressure Index (ABPI) A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery.
Diagnostic Test: Exercise Ankle Brachial Pressure Index (ABPI) A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery, following the participant completing 50 consecutive repetitions of active dorsiflexion whilst standing.
Diagnostic Test: Audible handheld Doppler Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.
Diagnostic Test: Visual handheld Doppler Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.
Diagnostic Test: Podiatry Ankle Duplex scan (PAD-scan) Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.
To be used in 3 participating centers only.
|
|---|---|
|
Age, Continuous
|
61.48 years
STANDARD_DEVIATION 12.78 • n=99 Participants
|
|
Sex: Female, Male
Female
|
215 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
388 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
429 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
83 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black
|
47 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Mixed race / multiple ethnic background
|
12 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other ethnic group
|
31 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=99 Participants
|
|
Diabetes mellitus type
Type 1
|
115 Participants
n=99 Participants
|
|
Diabetes mellitus type
Type 2
|
480 Participants
n=99 Participants
|
|
Diabetes mellitus type
Missing
|
8 Participants
n=99 Participants
|
|
Previous history of diabetic foot ulcer
Yes
|
68 Participants
n=99 Participants
|
|
Previous history of diabetic foot ulcer
No
|
595 Participants
n=99 Participants
|
|
Leg pain at rest
Yes
|
165 Participants
n=99 Participants
|
|
Leg pain at rest
No
|
438 Participants
n=99 Participants
|
|
Leg pain whilst exercising
Yes
|
157 Participants
n=99 Participants
|
|
Leg pain whilst exercising
No
|
446 Participants
n=99 Participants
|
|
Gangrene
Yes
|
8 Participants
n=99 Participants
|
|
Gangrene
No
|
595 Participants
n=99 Participants
|
|
Foot examination - ulceration
Yes
|
82 Participants
n=99 Participants
|
|
Foot examination - ulceration
No
|
521 Participants
n=99 Participants
|
|
Foot examination - Infection
Yes
|
27 Participants
n=99 Participants
|
|
Foot examination - Infection
No
|
576 Participants
n=99 Participants
|
|
Foot examination - Neuropathy present in index limb
Yes
|
148 Participants
n=99 Participants
|
|
Foot examination - Neuropathy present in index limb
No
|
455 Participants
n=99 Participants
|
|
Overall WIfI Score
Very Low
|
564 Participants
n=99 Participants
|
|
Overall WIfI Score
Low
|
13 Participants
n=99 Participants
|
|
Overall WIfI Score
Moderate
|
16 Participants
n=99 Participants
|
|
Overall WIfI Score
High
|
3 Participants
n=99 Participants
|
|
Overall WIfI Score
Missing
|
7 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.Population: Number of participants who underwent the index test
Diagnostic accuracy of the PAD-scan and other bedside tests will be compared to the results of a Magnetic resonance angiograph (MRA) or Computed tomography angiography (CTA) (reference test).
Outcome measures
| Measure |
Audible Doppler
n=536 Participants
Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.
|
Visual Doppler
n=536 Participants
Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.
|
Toe Brachial Pressure Index (TBPI)
n=521 Participants
TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.
|
Ankle Brachial Pressure Index (ABPI)
n=532 Participants
A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery.
|
Exercise Ankle Brachial Pressure Index (ABPI)
n=480 Participants
A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery, following the participant completing 50 consecutive repetitions of active dorsiflexion whilst standing.
|
Podiatry Ankle Duplex Scan (PAD-scan)
n=101 Participants
Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.
Used in 3 participating centers only.
|
DUS for All
DUS for all considers a scenario where all diabetic patients are offered anatomical imaging at baseline, without a previous bedside test.
|
|---|---|---|---|---|---|---|---|
|
Diagnostic Accuracy
Positive Predictive Value (PPV)
|
75 percentage
Interval 64.0 to 87.0
|
63 percentage
Interval 52.0 to 74.0
|
58 percentage
Interval 48.0 to 67.0
|
59 percentage
Interval 48.0 to 70.0
|
55 percentage
Interval 44.0 to 67.0
|
57 percentage
Interval 38.0 to 76.0
|
—
|
|
Diagnostic Accuracy
Sensitivity
|
36 percentage
Interval 27.0 to 45.0
|
42 percentage
Interval 33.0 to 51.0
|
55 percentage
Interval 46.0 to 64.0
|
41 percentage
Interval 32.0 to 50.0
|
41 percentage
Interval 31.0 to 51.0
|
89 percentage
Interval 74.0 to 100.0
|
—
|
|
Diagnostic Accuracy
Specificity
|
93 percentage
Interval 90.0 to 97.0
|
86 percentage
Interval 81.0 to 91.0
|
78 percentage
Interval 72.0 to 83.0
|
84 percentage
Interval 79.0 to 89.0
|
83 percentage
Interval 78.0 to 88.0
|
69 percentage
Interval 54.0 to 84.0
|
—
|
|
Diagnostic Accuracy
Negative Predictive Value (NPV)
|
72 percentage
Interval 66.0 to 77.0
|
72 percentage
Interval 66.0 to 78.0
|
76 percentage
Interval 70.0 to 81.0
|
71 percentage
Interval 66.0 to 77.0
|
74 percentage
Interval 68.0 to 80.0
|
93 percentage
Interval 84.0 to 100.0
|
—
|
PRIMARY outcome
Timeframe: 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.Population: Number of participants who underwent the index test
Diagnostic accuracy of the PAD-scan and other bedside tests will be compared to the results of a Magnetic resonance angiograph (MRA) or Computed tomography angiography (CTA) (reference test).
Outcome measures
| Measure |
Audible Doppler
n=536 Participants
Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.
|
Visual Doppler
n=536 Participants
Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.
|
Toe Brachial Pressure Index (TBPI)
n=521 Participants
TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.
|
Ankle Brachial Pressure Index (ABPI)
n=532 Participants
A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery.
|
Exercise Ankle Brachial Pressure Index (ABPI)
n=480 Participants
A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery, following the participant completing 50 consecutive repetitions of active dorsiflexion whilst standing.
|
Podiatry Ankle Duplex Scan (PAD-scan)
n=101 Participants
Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.
Used in 3 participating centers only.
|
DUS for All
DUS for all considers a scenario where all diabetic patients are offered anatomical imaging at baseline, without a previous bedside test.
|
|---|---|---|---|---|---|---|---|
|
Diagnostic Accuracy - Ratios
Negative Likelihood Ratio (NLR)
|
0.7 ratio
Interval 0.6 to 0.8
|
0.7 ratio
Interval 0.6 to 0.8
|
0.6 ratio
Interval 0.5 to 0.7
|
0.7 ratio
Interval 0.6 to 0.8
|
0.7 ratio
Interval 0.6 to 0.8
|
0.2 ratio
Interval 0.0 to 0.6
|
—
|
|
Diagnostic Accuracy - Ratios
Positive Likelihood Ratio (PLR)
|
5.3 ratio
Interval 3.0 to 9.4
|
3.0 ratio
Interval 2.0 to 4.5
|
2.5 ratio
Interval 1.8 to 3.4
|
2.6 ratio
Interval 1.7 to 3.8
|
2.4 ratio
Interval 1.6 to 3.6
|
2.9 ratio
Interval 1.7 to 4.9
|
—
|
|
Diagnostic Accuracy - Ratios
Odds Ratio (OR)
|
7.7 ratio
Interval 3.9 to 15.1
|
4.4 ratio
Interval 2.5 to 7.6
|
4.2 ratio
Interval 2.5 to 7.0
|
3.7 ratio
Interval 2.1 to 6.3
|
3.4 ratio
Interval 2.0 to 6.1
|
18.8 ratio
Interval 3.4 to 106.0
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The costs over 5 years for a hypothetical cohort of 1000 diabetic patients that is similar to the DM PAD cohort. Weighted average costs.
Incremental cost-effectiveness ratio at 5 years.
Outcome measures
| Measure |
Audible Doppler
n=1000 Participants
Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.
|
Visual Doppler
n=1000 Participants
Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.
|
Toe Brachial Pressure Index (TBPI)
n=1000 Participants
TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.
|
Ankle Brachial Pressure Index (ABPI)
n=1000 Participants
A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery.
|
Exercise Ankle Brachial Pressure Index (ABPI)
n=1000 Participants
A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery, following the participant completing 50 consecutive repetitions of active dorsiflexion whilst standing.
|
Podiatry Ankle Duplex Scan (PAD-scan)
n=1000 Participants
Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.
Used in 3 participating centers only.
|
DUS for All
n=1000 Participants
DUS for all considers a scenario where all diabetic patients are offered anatomical imaging at baseline, without a previous bedside test.
|
|---|---|---|---|---|---|---|---|
|
Health Economic Outcome - Cost Effectiveness
Cost (£)
|
11165437 GBP
Interval 10346360.0 to 12197728.0
|
11204467 GBP
Interval 10244720.0 to 12440400.0
|
11241003 GBP
Interval 10057894.0 to
|
11218496 GBP
Interval 10272695.0 to 12476374.0
|
11229209 GBP
Interval 10328808.0 to 12502669.0
|
11156745 GBP
Interval 11156745.0 to 11156745.0
|
11413487 GBP
Interval 9190648.0 to 14285664.0
|
|
Health Economic Outcome - Cost Effectiveness
Net benefit (£)
|
37186446 GBP
Interval 35752535.0 to 38475241.0
|
37310327 GBP
Interval 35587599.0 to 38724440.0
|
37607662 GBP
Interval 35404894.0 to 39371581.0
|
37273035 GBP
Interval 35626018.0 to 38725778.0
|
37267357 GBP
Interval 35554592.0 to 38677467.0
|
36240553 GBP
Interval 36240553.0 to 36240553.0
|
38641671 GBP
Interval 34660841.0 to 41716288.0
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Hypothetical cohort of 1000 diabetic patients that is similar to the DM PAD cohort
Incremental cost-effectiveness ratio at 5 years.
Outcome measures
| Measure |
Audible Doppler
n=1000 Participants
Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.
|
Visual Doppler
n=1000 Participants
Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.
|
Toe Brachial Pressure Index (TBPI)
n=1000 Participants
TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.
|
Ankle Brachial Pressure Index (ABPI)
n=1000 Participants
A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery.
|
Exercise Ankle Brachial Pressure Index (ABPI)
n=1000 Participants
A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery, following the participant completing 50 consecutive repetitions of active dorsiflexion whilst standing.
|
Podiatry Ankle Duplex Scan (PAD-scan)
n=1000 Participants
Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.
Used in 3 participating centers only.
|
DUS for All
n=1000 Participants
DUS for all considers a scenario where all diabetic patients are offered anatomical imaging at baseline, without a previous bedside test.
|
|---|---|---|---|---|---|---|---|
|
Health Economic Outcome - Cost Effectiveness (QALY)
|
2418 Quality Adjusted Life Years
Interval 2392.0 to 2448.0
|
2426 Quality Adjusted Life Years
Interval 2397.0 to 2454.0
|
2442 Quality Adjusted Life Years
Interval 2407.0 to 2477.0
|
2425 Quality Adjusted Life Years
Interval 2397.0 to 2453.0
|
2425 Quality Adjusted Life Years
Interval 2397.0 to 2455.0
|
2370 Quality Adjusted Life Years
Interval 2370.0 to 2370.0
|
2503 Quality Adjusted Life Years
Interval 2444.0 to 2548.0
|
SECONDARY outcome
Timeframe: 1 hour: all index tests will be performed on the same day of presentation.Population: Participant that underwent the index test
Patients will be asked to rate their experience of each index test on a Likert scale.
Outcome measures
| Measure |
Audible Doppler
n=603 Participants
Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.
|
Visual Doppler
n=603 Participants
Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.
|
Toe Brachial Pressure Index (TBPI)
n=603 Participants
TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.
|
Ankle Brachial Pressure Index (ABPI)
n=603 Participants
A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery.
|
Exercise Ankle Brachial Pressure Index (ABPI)
n=603 Participants
A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery, following the participant completing 50 consecutive repetitions of active dorsiflexion whilst standing.
|
Podiatry Ankle Duplex Scan (PAD-scan)
n=101 Participants
Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.
Used in 3 participating centers only.
|
DUS for All
DUS for all considers a scenario where all diabetic patients are offered anatomical imaging at baseline, without a previous bedside test.
|
|---|---|---|---|---|---|---|---|
|
Patient Acceptability
Missing
|
4 participants
|
6 participants
|
15 participants
|
9 participants
|
65 participants
|
0 participants
|
—
|
|
Patient Acceptability
Very unsatisfied
|
7 participants
|
7 participants
|
7 participants
|
11 participants
|
8 participants
|
2 participants
|
—
|
|
Patient Acceptability
Unsatisfied
|
1 participants
|
1 participants
|
0 participants
|
6 participants
|
6 participants
|
0 participants
|
—
|
|
Patient Acceptability
Neutral
|
6 participants
|
5 participants
|
6 participants
|
13 participants
|
12 participants
|
2 participants
|
—
|
|
Patient Acceptability
Satisfied
|
84 participants
|
81 participants
|
81 participants
|
89 participants
|
77 participants
|
21 participants
|
—
|
|
Patient Acceptability
Very satisfied
|
501 participants
|
503 participants
|
494 participants
|
475 participants
|
435 participants
|
77 participants
|
—
|
SECONDARY outcome
Timeframe: 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.Population: Recruited participants
Inability to perform, refusal and discontinuation of tests will be documented
Outcome measures
| Measure |
Audible Doppler
n=603 Participants
Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.
|
Visual Doppler
n=603 Participants
Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.
|
Toe Brachial Pressure Index (TBPI)
n=603 Participants
TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.
|
Ankle Brachial Pressure Index (ABPI)
n=603 Participants
A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery.
|
Exercise Ankle Brachial Pressure Index (ABPI)
n=603 Participants
A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery, following the participant completing 50 consecutive repetitions of active dorsiflexion whilst standing.
|
Podiatry Ankle Duplex Scan (PAD-scan)
n=103 Participants
Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.
Used in 3 participating centers only.
|
DUS for All
DUS for all considers a scenario where all diabetic patients are offered anatomical imaging at baseline, without a previous bedside test.
|
|---|---|---|---|---|---|---|---|
|
Technical Success
Assessment performed - yes
|
603 Participants
|
603 Participants
|
590 Participants
|
599 Participants
|
540 Participants
|
102 Participants
|
—
|
|
Technical Success
Assessment discontinued - yes
|
0 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
0 Participants
|
—
|
|
Technical Success
Assessment performed - no
|
0 Participants
|
0 Participants
|
13 Participants
|
4 Participants
|
63 Participants
|
1 Participants
|
—
|
|
Technical Success
Assessment discontinued - no
|
603 Participants
|
603 Participants
|
586 Participants
|
596 Participants
|
533 Participants
|
102 Participants
|
—
|
Adverse Events
All Participants
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=604 participants at risk
Diagnostic Test: Toe Brachial Pressure Index (TBPI) TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.
Diagnostic Test: Ankle Brachial Pressure Index (ABPI) A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery.
Diagnostic Test: Exercise Ankle Brachial Pressure Index (ABPI) A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery, following the participant completing 50 consecutive repetitions of active dorsiflexion whilst standing.
Diagnostic Test: Audible handheld Doppler Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.
Diagnostic Test: Visual handheld Doppler Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.
Diagnostic Test: Podiatry Ankle Duplex scan (PAD-scan) Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.
To be used in 3 participating centers only.
|
|---|---|
|
Vascular disorders
Bilateral Leg pain
|
0.17%
1/604 • Number of events 1 • Reported during the study duration; approximately 6 weeks (from baseline until scan performed).
An AE is any untoward medical occurrence in a patient or clinical trial participant. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, whether or not considered related to the trial protocol. For the purposes of the study, only AEs related to study procedures were recorded.
|
|
Gastrointestinal disorders
Vomiting
|
0.17%
1/604 • Number of events 1 • Reported during the study duration; approximately 6 weeks (from baseline until scan performed).
An AE is any untoward medical occurrence in a patient or clinical trial participant. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, whether or not considered related to the trial protocol. For the purposes of the study, only AEs related to study procedures were recorded.
|
|
Vascular disorders
Cramp and leg pain
|
0.17%
1/604 • Number of events 1 • Reported during the study duration; approximately 6 weeks (from baseline until scan performed).
An AE is any untoward medical occurrence in a patient or clinical trial participant. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, whether or not considered related to the trial protocol. For the purposes of the study, only AEs related to study procedures were recorded.
|
|
Vascular disorders
Leg pain
|
0.17%
1/604 • Number of events 1 • Reported during the study duration; approximately 6 weeks (from baseline until scan performed).
An AE is any untoward medical occurrence in a patient or clinical trial participant. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, whether or not considered related to the trial protocol. For the purposes of the study, only AEs related to study procedures were recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place