Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes

Peripheral Arterial Disease Clinical Trial

— DM PAD  

Official title:

Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05009602
• Other study ID #: 21CX7046
• Status: Active, not recruiting
• Start date: March 14, 2022
• Est. completion date: February 28, 2024

Study information

• Verified date: January 2024
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 604
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged =18 years
• Known history of diabetes

Exclusion Criteria:

• PAD status known on imaging
• Known history of PAD intervention
• CTA and MRA contraindications- renal impairment, pregnancy, contrast medium hypersensitivity/allergy, non-compatible implants (MRA only).
• Unable to provide appropriate informed consent.

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Critical Limb Ischemia
• Critical Lower Limb Ischemia
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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.
• 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.
• 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.
• Audible handheld Doppler
Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.
• Visual handheld Doppler
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)
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.

Locations

Country	Name	City	State
United Kingdom	Mid and South Essex NHS Foundation Trust	Basildon
United Kingdom	Cardiff and Vale UHB	Cardiff
United Kingdom	University Hospitals of Derby and Burton NHS Foundation Trust	Derby
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow
United Kingdom	Hull University Teaching Hospitals NHS Trust	Hull
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester
United Kingdom	Central London Community Healthcare NHS Trust sites	London
United Kingdom	Chelsea and Westminster Hospital NHS Foundation Trust	London
United Kingdom	Hammersmith and Fulham Partnership	London
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	St George's University Hospitals NHS Foundation Trust	London
United Kingdom	South Tees Hospitals NHS Foundation Trust	Middlesbrough
United Kingdom	Nottingham University Hospitals (NUH) NHS Trust	Nottingham
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford
United Kingdom	University Hospitals Plymouth NHS Trust	Plymouth
United Kingdom	University Hospitals Southampton NHS Foundation Trust	Southampton
United Kingdom	Worcestershire Acute Hospitals NHS Trust	Worcester

Sponsors (4)

Lead Sponsor	Collaborator
Imperial College London	Universidad de Granada, University of Edinburgh, University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	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 of test	Cost of the test, including direct costs and amortisation of capital equipment and use of other healthcare resources for prevention and treatment of the disease over a time horizon of 5 years.	1 hour: all index tests will be performed on the same day of presentation.
Secondary	Health economic outcome - Quality Adjusted Life Years	Quality Adjusted Life Years at 5 years	1 hour: all index tests will be performed on the same day of presentation.
Secondary	Health economic outcome - cost effectiveness	Incremental cost-effectiveness ratio at 5 years.	1 hour: all index tests will be performed on the same day of presentation.
Secondary	Specificity of index tests	Comparing index tests to reference tests.	6 weeks
Secondary	Likelihood ratios of index tests	Comparing index tests to reference tests.	6 weeks
Secondary	Predictive values of index tests	Comparing index tests to reference tests.	6 weeks
Secondary	Diagnostic odds ratio of index tests	Comparing index tests to reference tests.	6 weeks
Secondary	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.
Secondary	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.
Secondary	Inter- and intra-rater reliability	Repeating of index tests by the same and by an alternative operator for the assessment intra- and inter-rater reliability, respectively (only performed in the first 100 volunteering patients).	6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.