A comparison of automatic ABPI vs Manual ABPI device scores

  • Research type

    Research Study

  • Full title

    Comparing the Ankle Brachial Pressure Index score of automatic ABPI device vs manual ABPI device to classify lower limb ulcers and provide treatment in patients under Community services.

  • IRAS ID

    341833

  • Contact name

    Jamal Hossain

  • Contact email

    MJH1N23@SOTON.AC.UK

  • Sponsor organisation

    University of Southampton

  • Clinicaltrials.gov Identifier

    NCT06557538

  • Duration of Study in the UK

    0 years, 8 months, 20 days

  • Research summary

    The aim of the study is to compare the Ankle Brachial Pressure Index (ABPI) scores of two devices. The two devices that will be compared are the MESI MD ABPI automatic device and the Huntleigh Dopplex manual device.
    The Huntleigh Dopplex manual device is widely used, though the MESI MD ABPI automatic devices can reduce waiting times, reduce discomfort for patients and save nursing time.
    ABPI devices provide a score that supports nurses to provide suitable treatment for patients with a lower limb ulcer.
    In the community, patients with lower limb ulcers are offered an ABPI assessment and then treatment is decided based on the score.
    Participants will be patients with lower limb ulcers referred to community nursing for a lower limb and ABPI assessment. At their routine appointment patients will have a manual assessment and an automatic assessment, and the results will be compared.
    The study will take place in the county of Berkshire either in patients’ homes or in the lower limb clinic. Registered nurses will undertake all assessments.
    The direct care part of the study will run from July 2024 – December 2024.
    The data will be pseudonymised, and the findings written as a report that may be sent for publishing.

  • REC name

    North West - Preston Research Ethics Committee

  • REC reference

    24/NW/0233

  • Date of REC Opinion

    31 Jul 2024

  • REC opinion

    Favourable Opinion