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

Last updated: January 3, 2024
Sponsor: Imperial College London
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Ulcers

Circulation Disorders

Treatment

Visual handheld Doppler

Exercise Ankle Brachial Pressure Index (ABPI)

Audible handheld Doppler

Clinical Study ID

NCT05009602
21CX7046
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Aged ≥18 years
  • Known history of diabetes

Exclusion

Exclusion Criteria:

  • PAD status known on imaging
  • Known history of PAD intervention
  • CTA and MRA contraindications- renal impairment, pregnancy, contrast mediumhypersensitivity/allergy, non-compatible implants (MRA only).
  • Unable to provide appropriate informed consent.

Study Design

Total Participants: 604
Treatment Group(s): 6
Primary Treatment: Visual handheld Doppler
Phase:
Study Start date:
March 14, 2022
Estimated Completion Date:
February 28, 2024

Connect with a study center

  • Mid and South Essex NHS Foundation Trust

    Basildon, SS16 5NL
    United Kingdom

    Site Not Available

  • Cardiff and Vale UHB

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

  • St George's Medical Practice

    Darlington, DL2 1BY
    United Kingdom

    Site Not Available

  • University Hospitals of Derby and Burton NHS Foundation Trust

    Derby, DE22 3NE
    United Kingdom

    Site Not Available

  • NHS Greater Glasgow and Clyde

    Glasgow, G12 0XH
    United Kingdom

    Site Not Available

  • Hull University Teaching Hospitals NHS Trust

    Hull, HU3 2JZ
    United Kingdom

    Site Not Available

  • University Hospitals of Leicester NHS Trust

    Leicester, LE1 5WW
    United Kingdom

    Site Not Available

  • Central London Community Healthcare NHS Trust sites

    London, NW1 5JD
    United Kingdom

    Site Not Available

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London, SW10 9NH
    United Kingdom

    Site Not Available

  • Hammersmith and Fulham Partnership

    London,
    United Kingdom

    Site Not Available

  • Imperial College Healthcare NHS Trust

    London, W6 8RF
    United Kingdom

    Site Not Available

  • Kings College Hospital NHS Foundation Trust

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • St George's University Hospitals NHS Foundation Trust

    London, SW17 0QT
    United Kingdom

    Site Not Available

  • South Tees Hospitals NHS Foundation Trust

    Middlesbrough, TS4 3BW
    United Kingdom

    Site Not Available

  • Aneurin Bevan University Health Board

    Newport, NP20 2UB
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals (NUH) NHS Trust

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX4 2PG
    United Kingdom

    Site Not Available

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • Solent Community NHS Trust

    Portsmouth, PO3 6AD
    United Kingdom

    Site Not Available

  • University Hospitals Southampton NHS Foundation Trust

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Somerset NHS Foundation Trust

    Taunton, TA1 5DA
    United Kingdom

    Site Not Available

  • Worcestershire Acute Hospitals NHS Trust

    Worcester, WR5 1DD
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.