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

Active, not recruiting

• Conditions: Diabetic Foot Ulcer; Critical Limb Ischemia; Critical Lower Limb Ischemia; Peripheral Artery Disease; Peripheral Vascular Diseases; Diabetic Foot; Peripheral Arterial Disease

• Registration Number: NCT05009602
• Lead Sponsor: Imperial College London

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-11
• Study First Posted: 2021-08-17
• Study Start: 2022-03-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 604

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	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 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).

Secondary Outcome Measures

Name	Time	Method
Diagnostic odds ratio of index tests	6 weeks	Comparing index tests to reference tests.
Patient acceptability	1 hour: all index tests will be performed on the same day of presentation.	Patients will be asked to rate their experience of each index test on a Likert scale.
Likelihood ratios of index tests	6 weeks	Comparing index tests to reference tests.
Inter- and intra-rater reliability	6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.	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).
Specificity of index tests	6 weeks	Comparing index tests to reference tests.
Predictive values of index tests	6 weeks	Comparing index tests to reference tests.
Health economic outcome - cost of test	1 hour: all index tests will be performed on the same day of presentation.	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.
Health economic outcome - Quality Adjusted Life Years	1 hour: all index tests will be performed on the same day of presentation.	Quality Adjusted Life Years at 5 years
Health economic outcome - cost effectiveness	1 hour: all index tests will be performed on the same day of presentation.	Incremental cost-effectiveness ratio at 5 years.
Technical success	6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.	Inability to perform, refusal and discontinuation of tests will be documented

Trial Locations

Locations (17)

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

St George's University Hospitals NHS Foundation Trust; 🇬🇧 London, United Kingdom

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom

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