N/A
N=604
Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes
Diabetic Foot · Peripheral Arterial Disease · Diabetic Foot Ulcer · Peripheral Vascular Diseases · Peripheral Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT05009602 ↗Enrolled (actual)
604
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Diagnostic Accuracy — 36; 42; 55; 41 percentage
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 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) (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Accuracy |
36; 42; 55; 41; 41; 89 | — |
| PRIMARY Diagnostic Accuracy - Ratios |
0.7; 0.7; 0.6; 0.7; 0.7; 0.2 | — |
| SECONDARY Health Economic Outcome - Cost Effectiveness |
11165437; 11204467; 11241003; 11218496; 11229209; 11156745 | — |
| SECONDARY Health Economic Outcome - Cost Effectiveness (QALY) |
2418; 2426; 2442; 2425; 2425; 2370 | — |
| SECONDARY Patient Acceptability |
7; 7; 7; 11; 8; 2 | — |
| SECONDARY Technical Success |
603; 603; 590; 599; 540; 102 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05009602). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.