Diabetic FootDM PADNCT05009602

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

An observational study of Diabetic Foot and Peripheral Arterial Disease, run by Imperial College London at 17 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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)). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Foot, Peripheral Arterial Disease, Diabetic Foot Ulcer
What is being tested?: Toe Brachial Pressure Index (TBPI), Ankle Brachial Pressure Index (ABPI) and Exercise Ankle Brachial Pressure Index (ABPI)
How many people: 604 participants
Where: 17 sitesUnited Kingdom
Study dates: 14 Mar 2022to 28 Feb 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult patients with a diagnosis of diabetes.

Who may be able to join

Aged ≥18 years
Known history of diabetes

Who cannot join

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.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United Kingdom17 sites

Mid and South Essex NHS Foundation Trust
Basildon, SS16 5NL
Cardiff and Vale UHB
Cardiff, CF14 4XW
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, DE22 3NE
NHS Greater Glasgow and Clyde
Glasgow, G12 0XH
Hull University Teaching Hospitals NHS Trust
Hull, HU3 2JZ
University Hospitals of Leicester NHS Trust
Leicester, LE1 5WW
Central London Community Healthcare NHS Trust sites
London, NW1 5JD
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT
Imperial College Healthcare NHS Trust
London, W6 8RF
Hammersmith and Fulham Partnership
London
South Tees Hospitals NHS Foundation Trust
Middlesbrough, TS4 3BW
Nottingham University Hospitals (NUH) NHS Trust
Nottingham, NG5 1PB
Oxford University Hospitals NHS Foundation Trust
Oxford, OX4 2PG
University Hospitals Plymouth NHS Trust
Plymouth, PL6 8DH
University Hospitals Southampton NHS Foundation Trust
Southampton, SO16 6YD
Worcestershire Acute Hospitals NHS Trust
Worcester, WR5 1DD

Other trials in United Kingdom

About this study

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
Being tested: Toe Brachial Pressure Index (TBPI), Ankle Brachial Pressure Index (ABPI), Exercise Ankle Brachial Pressure Index (ABPI), Audible handheld Doppler, Visual handheld Doppler
Medical subject headings: Diabetic Foot, Peripheral Arterial Disease, Peripheral Vascular Diseases, Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Toe Brachial Pressure Index (TBPI)Diagnostic test
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)Diagnostic test
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)Diagnostic test
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 DopplerDiagnostic test
Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.
Visual handheld DopplerDiagnostic test
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)Diagnostic test
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.

Study groups in NCT05009602
Study group	Role	What they receive
Participating Centre		To complete all index tests and reference scan Receives: Diagnostic Test: Toe Brachial Pressure Index (TBPI); Diagnostic Test: Ankle Brachial Pressure Index (ABPI); Diagnostic Test: Exercise Ankle Brachial Pressure Index (ABPI); Diagnostic Test: Audible handheld Doppler; Diagnostic Test: Visual handheld Doppler; Diagnostic Test: Podiatry Ankle Duplex scan (PAD-scan)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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 - Ratios
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).
Measured: 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 outcomes (4)

Health Economic Outcome - Cost Effectiveness
Incremental cost-effectiveness ratio at 5 years.
Measured: 5 years
Health Economic Outcome - Cost Effectiveness (QALY)
Incremental cost-effectiveness ratio at 5 years.
Measured: 5 years
Patient Acceptability
Patients will be asked to rate their experience of each index test on a Likert scale.
Measured: 1 hour: all index tests will be performed on the same day of presentation.
Technical Success
Inability to perform, refusal and discontinuation of tests will be documented
Measured: 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Mar 202228 Feb 2024

First posted17 Aug 2021
Study start14 Mar 2022
Primary completion28 Feb 2024
Study completion28 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetic FootStudies of the same condition, open and under way.
More trials run by Imperial College LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 604 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05009602
Sponsor's protocol ID: 21CX7046
Acronym: DM PAD
Status last verified: Aug 2025
First submitted: 4 Aug 2021
Last updated: 3 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Normahani P, Burgess L, Norrie J, Epstein DM, Kandiyil N, Saratzis A, Smith S, Khunti K, Edmonds M, Ahluwalia R, Coward T, Hartshorne T, Ashwell S, Shalhoub J, Pigott E, Davies AH, Jaffer U; DM PAD study investigators. Study protocol for a multicentre comparative diagnostic accuracy study of tools to establish the presence and severity of peripheral arterial disease in people with diabetes mellitus: the DM PAD study. BMJ Open. 2022 Nov 3;12(11):e066950. doi: 10.1136/bmjopen-2022-066950.
PubMed 36328388

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetic Foot trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes
ClinicalTrials.gov ID: NCT05009602
Acronym / sponsor ID: DM PAD / 21CX7046
Conditions: Diabetic Foot, Peripheral Arterial Disease, Diabetic Foot Ulcer, Peripheral Vascular Diseases, Peripheral Artery Disease, Critical Limb Ischemia
Study type: Observational
Recruitment status: Completed
Enrolment: 604 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Collaborators: University of Leicester, University of Edinburgh, Universidad de Granada
Study start: 14 Mar 2022 (actual)
Primary completion: 28 Feb 2024 (actual)
Study completion: 28 Feb 2024 (actual)
First posted: 17 Aug 2021 (actual)
Results: Posted 3 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Participating Centre	–	Diagnostic Test: Toe Brachial Pressure Index (TBPI), Diagnostic Test: Ankle Brachial Pressure Index (ABPI), Diagnostic Test: Exercise Ankle Brachial Pressure Index (ABPI), Diagnostic Test: Audible handheld Doppler, Diagnostic Test: Visual handheld Doppler, Diagnostic Test: Podiatry Ankle Duplex scan (PAD-scan)To complete all index tests and reference scan

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult patients with a diagnosis of diabetes.

Key inclusion criteria (2 listed)

Aged ≥18 years
Known history of diabetes

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Participating Centre
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	Participating Centre
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	Participating Centre
Audible handheld DopplerAudible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.	Diagnostic test	Participating Centre
Visual handheld DopplerVisual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.	Diagnostic test	Participating Centre
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.	Diagnostic test	Participating Centre

Primary outcome

Diagnostic Accuracy
Time frame: 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).
Diagnostic Accuracy - Ratios
Time frame: 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).

4 secondary outcomes

Health Economic Outcome - Cost Effectiveness
Time frame: 5 years
Health Economic Outcome - Cost Effectiveness (QALY)
Time frame: 5 years
Patient Acceptability
Time frame: 1 hour: all index tests will be performed on the same day of presentation.
Technical Success
Time frame: 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.

Results and safety

Results posted to the registry on 3 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	604	536

Primary outcome: Diagnostic Accuracy

Time frame: 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.. Number (95% Confidence Interval). Unit: percentage

Measure	Audible Doppler n = 536	Visual Doppler n = 536	Toe Brachial Pressure Index (TBPI) n = 521	Ankle Brachial Pressure Index (ABPI) n = 532	Exercise Ankle Brachial Pressure Index (ABPI) n = 480	Podiatry Ankle Duplex Scan (PAD-scan) n = 101
Sensitivity	36 (27 to 45)	42 (33 to 51)	55 (46 to 64)	41 (32 to 50)	41 (31 to 51)	89 (74 to 100)
Specificity	93 (90 to 97)	86 (81 to 91)	78 (72 to 83)	84 (79 to 89)	83 (78 to 88)	69 (54 to 84)
Positive Predictive Value (PPV)	75 (64 to 87)	63 (52 to 74)	58 (48 to 67)	59 (48 to 70)	55 (44 to 67)	57 (38 to 76)
Negative Predictive Value (NPV)	72 (66 to 77)	72 (66 to 78)	76 (70 to 81)	71 (66 to 77)	74 (68 to 80)	93 (84 to 100)

Population analysed: Number of participants who underwent the index test

Primary outcome: Diagnostic Accuracy - Ratios

Time frame: 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.. Number (95% Confidence Interval). Unit: ratio

Measure	Audible Doppler n = 536	Visual Doppler n = 536	Toe Brachial Pressure Index (TBPI) n = 521	Ankle Brachial Pressure Index (ABPI) n = 532	Exercise Ankle Brachial Pressure Index (ABPI) n = 480	Podiatry Ankle Duplex Scan (PAD-scan) n = 101
Negative Likelihood Ratio (NLR)	0.7 (0.6 to 0.8)	0.7 (0.6 to 0.8)	0.6 (0.5 to 0.7)	0.7 (0.6 to 0.8)	0.7 (0.6 to 0.8)	0.2 (0.0 to 0.6)
Positive Likelihood Ratio (PLR)	5.3 (3.0 to 9.4)	3.0 (2.0 to 4.5)	2.5 (1.8 to 3.4)	2.6 (1.7 to 3.8)	2.4 (1.6 to 3.6)	2.9 (1.7 to 4.9)
Odds Ratio (OR)	7.7 (3.9 to 15.1)	4.4 (2.5 to 7.6)	4.2 (2.5 to 7.0)	3.7 (2.1 to 6.3)	3.4 (2.0 to 6.1)	18.8 (3.4 to 106)

Population analysed: Number of participants who underwent the index test

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Reported during the study duration; approximately 6 weeks (from baseline until scan performed).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 604 (0%)	4 of 604 (0.7%)	1 of 604

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36328388Normahani P, Burgess L, Norrie J, Epstein DM, Kandiyil N, Saratzis A, Smith S, Khunti K, Edmonds M, Ahluwalia R, Coward T, Hartshorne T, Ashwell S, Shalhoub J, Pigott E, Davies AH, Jaffer U; DM PAD study investigators. Study protocol for a multicentre comparative diagnostic accuracy study of tools to establish the presence and severity of peripheral arterial disease in people with diabetes mellitus: the DM PAD study. BMJ Open. 2022 Nov 3;12(11):e066950. doi: 10.1136/bmjopen-2022-066950.
Individual participant dataSharing planned: No

Related trials for Diabetic Foot

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Usman Jaffer principal investigator

Chief Investigator

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Foot and Peripheral Arterial Disease, run by Imperial College London at 17 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic Accuracy (time frame: 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05009602, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.