NCT05009602

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 604 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-14
• Primary completion: 2024-02-28
• Completion: 2024-02-28
• First posted: 2021-08-17
• Last updated: 2025-09-03
• Results posted: 2025-09-03

Locations

17 sites across 1 country: United Kingdom