Clinical trial NCT05009602: Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes
Official title: Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetic Foot
Peripheral Arterial Disease
Diabetic Foot Ulcer
Peripheral Vascular Diseases
Peripheral Artery Disease
Critical Limb Ischemia
Critical Lower Limb Ischemia
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: University of Leicester
name: University of Edinburgh
name: Universidad de Granada
First posted: 2021-08-17
Enrollment: 604
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a diagnosis of diabetes.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 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:
measure: Health economic outcome - cost of test
timeFrame: 1 hour: all index tests will be performed on the same day of presentation.
measure: Health economic outcome - Quality Adjusted Life Years
timeFrame: 1 hour: all index tests will be performed on the same day of presentation.
measure: Health economic outcome - cost effectiveness
timeFrame: 1 hour: all index tests will be performed on the same day of presentation.
measure: Specificity of index tests
timeFrame: 6 weeks
measure: Likelihood ratios of index tests
timeFrame: 6 weeks
measure: Predictive values of index tests
timeFrame: 6 weeks
measure: Diagnostic odds ratio of index tests
timeFrame: 6 weeks
measure: Patient acceptability
timeFrame: 1 hour: all index tests will be performed on the same day of presentation.
measure: Technical success
timeFrame: 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.
measure: Inter- and intra-rater reliability
timeFrame: 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Mid and South Essex NHS Foundation Trust
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale UHB
city: Derby
country: United Kingdom
facility: University Hospitals of Derby and Burton NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: London
country: United Kingdom
facility: Central London Community Healthcare NHS Trust sites
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: Hammersmith and Fulham Partnership
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals (NUH) NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust
city: Southampton
country: United Kingdom
facility: University Hospitals Southampton NHS Foundation Trust
city: Worcester
country: United Kingdom
facility: Worcestershire Acute Hospitals NHS Trust
Study officials:
affiliation: Chief Investigator
name: Usman Jaffer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.