Improving Radiological Outcomes in Arterial Disease

  • Research type

    Research Study

  • Full title

    Improving Radiological Outcomes in Arterial Disease - a pilot evaluation of the Pedra skin perfusion monitoring system

  • IRAS ID

    233390

  • Contact name

    Kareen Looi

  • Contact email

    klooi@pedratech.com

  • Sponsor organisation

    Pedra Technology Pte

  • Clinicaltrials.gov Identifier

    NCT03294902

  • Duration of Study in the UK

    0 years, 11 months, 31 days

  • Research summary

    Diabetes and arterial disease are increasing worldwide and this is leading to an increase in amputations. Many patients with poor lower limb circulation are treated with angioplasty or stenting. Often the patients have multiple areas of disease and it is not always clear how many of these need to be treated to adequately improve lower limb circulation enough to improve the patient's symptoms.
    Currently, it is not always easy to quantify when the circulation has been improved enough and the clinician treating the patient usually makes a judgement call on the appearance of the angiogram before and after the intervention. The device under investigation can provide numerical feedback about changes in bloodflow in the skin. This pilot study will evaluate the changes in skin blood flow after intervention with either angioplasty or stenting, with a view to designing a larger study.

  • REC name

    East of England - Cambridge Central Research Ethics Committee

  • REC reference

    17/EE/0483

  • Date of REC Opinion

    25 Jan 2018

  • REC opinion

    Further Information Favourable Opinion