Impact of Loading Pressure on Endothelial Function in Diabetic Foot v1

  • Research type

    Research Study

  • Full title

    Assessment of the Impact of Loading Pressure on Endothelial Function in Diabetic Foot

  • IRAS ID

    195922

  • Contact name

    Rami Abboud

  • Contact email

    r.j.abboud@dundee.ac.uk

  • Sponsor organisation

    Tayside Medical Science Centre

  • Clinicaltrials.gov Identifier

    15161, UREC (University of Dundee Research Ethics Committee) approval ; 2015DM18, NHS Tayside R&D approval Reference Number

  • Duration of Study in the UK

    2 years, 9 months, 13 days

  • Research summary

    Foot problems account for the most serious and costly complication of diabetes. The major adverse outcomes of diabetic foot are foot ulcers and amputations which are considered preventable as 85% of amputations are preceded by foot ulceration. Despite high rates of ulcers located on the top of diabetic foot most of the earlier studies and guidelines were focused on those on the sole of the foot. This study aims to investigate two of those factors which are thought to contribute to diabetic foot ulcers on the top as well as the sole of the foot. This will include changes which occur to small blood vessels found just under the skin surface, and the pressure placed on the foot by shoes. This study will investigate these two factors together trying to find out if there are differences in the way the small blood vessels respond under pressure with diabetes when compared to a group of people without diabetes. In-shoe pressure measurement will be conducted into participant's own comfortable shoes and in a provided same size special shoes which is frequently prescribed to patients with diabetes. The activity of blood vessels will be assessed by placing a substance on the skin surface which when absorbed causes the small local vessels to enlarge temporarily and the amount of blood flowing through the vessels to increase. This increase in local blood flow can be measured on the skin surface by placing a probe against the skin.
    The results of this project will add to the understanding of foot ulcers development and may help in designing better future therapeutic interventions to prevent diabetic foot ulceration.

  • REC name

    London - Hampstead Research Ethics Committee

  • REC reference

    16/LO/0318

  • Date of REC Opinion

    10 Feb 2016

  • REC opinion

    Favourable Opinion