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This study will focus on determining;
In the UK, over 7,000 amputations are performed each year because of diabetes. Most of these (80%) occur when a foot wound, also known as an ulcer, does not heal. The most important cause of this is poor circulation to the feet. Currently, there are no accurate tests that foot specialists can use to detect poor circulation when they see patients. Because of this, poor circulation can be missed and its treatment delayed.
A focused ultrasound test at the ankle, using a sensor and gel on the skin, can detect poor circulation. It is safe, painless and I have previously proven that it can be learned and performed quickly. It may help avoid amputations by detecting poor circulation so that it can be treated quickly.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous pressure of oxygen (TcPO2) | Diagnostic Test | Measurements will be taken from the dorsum of the foot using an automated machine equipped with Clark electrodes. | ||
| 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. | ||
| 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. | ||
| Duplex Assist | Diagnostic Test | Continuous Doppler device which gives visual display of arterial spectral waveform at the ankle. | ||
| 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 DPA and PTA. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy | Diagnostic accuracy of the PAD-scan and other bedside tests will be compared to the results of a full lower limb Duplex Ultrasound scan (reference test). | 1 hour; all tests will be performed on the same day of presentation. |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients referred to the diabetic foot clinics at these sites will be asked to take part in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Jaffer Usman | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Middlesex University Hospital | London | TW76AF | United Kingdom | |||
| Imperial College NHS Healthcare Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36918215 | Derived | Elghazaly H, Howard T, Sanjay S, Mohamed OG, Sounderajah V, Mehar Z, Davies AH, Jaffer U, Normahani P. Evaluating the prognostic performance of bedside tests used for peripheral arterial disease diagnosis in the prediction of diabetic foot ulcer healing. BMJ Open Diabetes Res Care. 2023 Mar;11(2):e003110. doi: 10.1136/bmjdrc-2022-003110. | |
| 32029491 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Participants | Participants with diabetes were consecutively enrolled into the study across 2 centers. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2019 |
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| London |
| W21NY |
| United Kingdom |
| Normahani P, Poushpas S, Alaa M, Bravis V, Aslam M, Jaffer U. Study protocol for a comparative diagnostic accuracy study of bedside tests used to detect arterial disease in diabetes: TEsting for Arterial disease in Diabetes (TrEAD) study. BMJ Open. 2020 Feb 5;10(2):e033753. doi: 10.1136/bmjopen-2019-033753. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Participants | Participants with diabetes were consecutively enrolled into the study across 2 centers. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Active ulceration | Count of Participants | Participants |
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| Neuropathy | Count of Participants | Participants |
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| 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 full lower limb Duplex Ultrasound scan (reference test). | Missing data were observed in 7 (2.3%) patients for ABPI, 71 (23.3%) patients for TBPI and 16 (5.2%) patients for TcPO2. | Posted | Number | 95% Confidence Interval | Percent | 1 hour; all tests will be performed on the same day of presentation. |
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The study duration is short and transient as index and reference tests are completed in a single visit. Study duration is therefore less than 1 hour. Additionally, all tests were non-invasive. Therefore, adverse events were not foreseen or encountered.
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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 | Study Participants | Participants with diabetes were consecutively enrolled into the study across 2 centers. | 0 | 305 | 0 | 305 | 0 | 305 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Pasha Normahani | Imperial College London/ Imperial College Healthcare NHS Trust | 020 3312 6666 | switch | p.normahani@imperial.ac.uk |
| Aug 3, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| D000089802 | Chronic Limb-Threatening Ischemia |
| D004194 | Disease |
| 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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| ABPI sensitivity |
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| ABPI specificity |
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| TcPO2 sensitivity |
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| TcPO2 specificity |
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