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

Imperial College London

Status

Completed

Conditions

Diabetic Foot

Peripheral Artery Disease

Peripheral Vascular Diseases

Critical Limb Ischemia

Critical Lower Limb Ischemia

Peripheral Arterial Disease

Diabetic Foot Ulcer

Treatments

Diagnostic Test: Podiatry Ankle Duplex scan (PAD-scan)

Diagnostic Test: Audible handheld Doppler

Diagnostic Test: Ankle Brachial Pressure Index (ABPI)

Diagnostic Test: Toe Brachial Pressure Index (TBPI)

Diagnostic Test: Visual handheld Doppler

Diagnostic Test: Exercise Ankle Brachial Pressure Index (ABPI)

Study type

Observational

Funder types

Other

Identifiers

NCT05009602

21CX7046

Details and patient eligibility

About

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).

Enrollment

604 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.