CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 604 enrolled
Drug / intervention
Toe Brachial Pressure Index (TBPI) +5 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05009602
NCT05009602N/ACompleted
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Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes

Imperial College London·observational·Posted Aug 17, 2021·Updated Sep 3, 2025

In Brief

An observational study evaluating Toe Brachial Pressure Index (TBPI), Ankle Brachial Pressure Index (ABPI), and 4 other interventions for Diabetic Foot and 6 related conditions. Completed, enrolled 604 participants across 17 sites.

Detailed 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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot, Peripheral Arterial Disease, Diabetic Foot Ulcer, Peripheral Vascular Diseases, Peripheral Artery Disease, Critical Limb Ischemia, Critical Lower Limb Ischemia
CountriesUnited Kingdom
CollaboratorsUniversity of Leicester, University of Edinburgh, Universidad de Granada

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 17, 2021
Enrollment StartMar 14, 2022
Primary CompletionFeb 28, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.9 years ago

Interventions

Toe Brachial Pressure Index (TBPI)other

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)other

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)other

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 Dopplerother

Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.

Visual handheld Dopplerother

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)other

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.