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| Name | Class |
|---|---|
| University of Leicester | OTHER |
| University of Edinburgh | OTHER |
| Universidad de Granada | OTHER |
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In the UK there are over 7,000 leg amputations each year because of diabetes. The most important cause of this is poor circulation. The detection of poor circulation in patients with diabetes is difficult. A number of tests exist to detect poor circulation (known as peripheral arterial disease (PAD)). However, there is confusion as to which is the gold standard.
The DM PAD study aims to determine the diagnostic performance of index tests (audible handheld Doppler, visual handheld Doppler, ankle brachial pressure index (ABPI), exercise ABPI and toe brachial pressure index (TBPI)) for the diagnosis of PAD in patients with diabetes as determined by a reference test (CTA or MRA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participating Centre | To complete all index tests and reference scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toe Brachial Pressure Index (TBPI) | Diagnostic Test | TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy | 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). | 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests. |
| Diagnostic Accuracy - Ratios | 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). | 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests. |
| Measure | Description | Time Frame |
|---|---|---|
| Health Economic Outcome - Cost Effectiveness | Incremental cost-effectiveness ratio at 5 years. | 5 years |
| Health Economic Outcome - Cost Effectiveness (QALY) | Incremental cost-effectiveness ratio at 5 years. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with a diagnosis of diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| Usman Jaffer | Chief Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mid and South Essex NHS Foundation Trust | Basildon | SS16 5NL | United Kingdom | |||
| Cardiff and Vale UHB |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36328388 | Derived | Normahani P, Burgess L, Norrie J, Epstein DM, Kandiyil N, Saratzis A, Smith S, Khunti K, Edmonds M, Ahluwalia R, Coward T, Hartshorne T, Ashwell S, Shalhoub J, Pigott E, Davies AH, Jaffer U; DM PAD study investigators. Study protocol for a multicentre comparative diagnostic accuracy study of tools to establish the presence and severity of peripheral arterial disease in people with diabetes mellitus: the DM PAD study. BMJ Open. 2022 Nov 3;12(11):e066950. doi: 10.1136/bmjopen-2022-066950. |
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Patients are assessed for eligibility and some are excluded as per eligibility criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 29, 2023 | Jun 11, 2025 |
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| Ankle Brachial Pressure Index (ABPI) | Diagnostic Test | 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) | Diagnostic Test | 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. |
|
| Audible handheld Doppler | Diagnostic Test | Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery. |
|
| Visual handheld Doppler | Diagnostic Test | Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device. |
|
| Podiatry Ankle Duplex scan (PAD-scan) | Diagnostic Test | 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. |
|
| 5 years |
| Patient Acceptability | Patients will be asked to rate their experience of each index test on a Likert scale. | 1 hour: all index tests will be performed on the same day of presentation. |
| Technical Success | Inability to perform, refusal and discontinuation of tests will be documented | 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests. |
| Cardiff |
| CF14 4XW |
| United Kingdom |
| University Hospitals of Derby and Burton NHS Foundation Trust | Derby | DE22 3NE | United Kingdom |
| NHS Greater Glasgow and Clyde | Glasgow | G12 0XH | United Kingdom |
| Hull University Teaching Hospitals NHS Trust | Hull | HU3 2JZ | United Kingdom |
| University Hospitals of Leicester NHS Trust | Leicester | LE1 5WW | United Kingdom |
| Central London Community Healthcare NHS Trust sites | London | NW1 5JD | United Kingdom |
| Chelsea and Westminster Hospital NHS Foundation Trust | London | SW10 9NH | United Kingdom |
| St George's University Hospitals NHS Foundation Trust | London | SW17 0QT | United Kingdom |
| Imperial College Healthcare NHS Trust | London | W6 8RF | United Kingdom |
| Hammersmith and Fulham Partnership | London | United Kingdom |
| South Tees Hospitals NHS Foundation Trust | Middlesbrough | TS4 3BW | United Kingdom |
| Nottingham University Hospitals (NUH) NHS Trust | Nottingham | NG5 1PB | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Oxford | OX4 2PG | United Kingdom |
| University Hospitals Plymouth NHS Trust | Plymouth | PL6 8DH | United Kingdom |
| University Hospitals Southampton NHS Foundation Trust | Southampton | SO16 6YD | United Kingdom |
| Worcestershire Acute Hospitals NHS Trust | Worcester | WR5 1DD | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics for 603 participants that underwent baseline index tests
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Diabetes mellitus type | Count of Participants | Participants |
| |||||||||||||||||||||||
| Previous history of diabetic foot ulcer | Count of Participants | Participants |
| |||||||||||||||||||||||
| Leg pain at rest | Count of Participants | Participants |
| |||||||||||||||||||||||
| Leg pain whilst exercising | Count of Participants | Participants |
| |||||||||||||||||||||||
| Gangrene | Count of Participants | Participants |
| |||||||||||||||||||||||
| Foot examination - ulceration | Count of Participants | Participants |
| |||||||||||||||||||||||
| Foot examination - Infection | Count of Participants | Participants |
| |||||||||||||||||||||||
| Foot examination - Neuropathy present in index limb | Count of Participants | Participants |
| |||||||||||||||||||||||
| Overall WIfI Score | Foot examination (neuropathy, pedal pulse examination, presence of diabetic foot ulcer (DFU), DFU severity using the WIfI (Wound, Ischemia, foot Infection) classification system. Categories are very low, low, moderate and high - referring to the risk of amputation at 1 year. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diagnostic Accuracy | 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). | Number of participants who underwent the index test | Posted | Number | 95% Confidence Interval | percentage | 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests. |
|
|
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Diagnostic Accuracy - Ratios | 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). | Number of participants who underwent the index test | Posted | Number | 95% Confidence Interval | ratio | 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests. |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Health Economic Outcome - Cost Effectiveness | Incremental cost-effectiveness ratio at 5 years. | The costs over 5 years for a hypothetical cohort of 1000 diabetic patients that is similar to the DM PAD cohort. Weighted average costs. | Posted | Mean | 95% Confidence Interval | GBP | 5 years |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Health Economic Outcome - Cost Effectiveness (QALY) | Incremental cost-effectiveness ratio at 5 years. | Hypothetical cohort of 1000 diabetic patients that is similar to the DM PAD cohort | Posted | Mean | 95% Confidence Interval | Quality Adjusted Life Years | 5 years |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Acceptability | Patients will be asked to rate their experience of each index test on a Likert scale. | Participant that underwent the index test | Posted | Number | participants | 1 hour: all index tests will be performed on the same day of presentation. |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Technical Success | Inability to perform, refusal and discontinuation of tests will be documented | Recruited participants | Posted | Count of Participants | Participants | 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 604 | 0 | 604 | 4 | 604 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bilateral Leg pain | Vascular disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Patient vomited after completing exercise ABPI |
| |
| Cramp and leg pain | Vascular disorders | Non-systematic Assessment | Cramp and leg pain after first visit |
| |
| Leg pain | Vascular disorders | Non-systematic Assessment | Participant complained of left lower leg pain and leg 'occasionally giving way' for five days following index tests. Reports nothing since |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Burgess | Imperial College London | 0203 311 5208 | l.burgess@imperial.ac.uk |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 14, 2023 | Jun 11, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
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| ID | Term |
|---|---|
| D055109 | Ankle Brachial Index |
| ID | Term |
|---|---|
| D001795 | Blood Pressure Determination |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Black |
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| Mixed race / multiple ethnic background |
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| Other ethnic group |
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| Missing |
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| Missing |
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| Moderate |
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| High |
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| Missing |
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| Specificity |
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| Positive Predictive Value (PPV) |
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| Negative Predictive Value (NPV) |
|
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.
| OG004 | 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. |
| OG005 | 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. Used in 3 participating centers only. |
|
|
| OG004 | 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. |
| OG005 | No Test | "No test" supposes a scenario where diabetic patients are offered neither bedside tests nor DUS, and receive usual care for non-PAD diabetic patients. |
| OG006 | DUS for All | DUS for all considers a scenario where all diabetic patients are offered anatomical imaging at baseline, without a previous bedside test. |
|
|
| OG004 | 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. |
| OG005 | No Test | "No test" supposes a scenario where diabetic patients are offered neither bedside tests nor DUS, and receive usual care for non-PAD diabetic patients. |
| OG006 | DUS for All | DUS for all considers a scenario where all diabetic patients are offered anatomical imaging at baseline, without a previous bedside test. |
|
|
| OG004 | 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. |
| OG005 | 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. Used in 3 participating centers only. |
|
|
| OG004 | 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. |
| OG005 | 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. Used in 3 participating centers only. |
|
|