Diabetic Foot Ulcer Prevention System (DFUPS)- part 2

  • Research type

    Research Study

  • Full title

    Efficacy and safety of Diabetic Foot Ulcer Prevention System (DFUPS) - a single blind randomised clinical trial in diabetic foot patients at high risk of foot ulceration

  • IRAS ID

    180918

  • Contact name

    Liba Stone

  • Contact email

    kch-tr.research@nhs.net

  • Sponsor organisation

    King's College Hospital NHS

  • Clinicaltrials.gov Identifier

    NCT02579070

  • Duration of Study in the UK

    years, 18 months, days

  • Research summary

    Neuropathy (nerve damage to the feet) is a common complication of diabetes. The inability of people with diabetes to detect pain puts them at risk of foot ulcer (skin breakdown). If not recognised and treated early, ulcers can become infected and in some cases lead to gangrene and even amputation. Prevention of foot ulcers in people with diabetes is essential. Before the foot ulcer occurs, the skin becomes inflamed, hot and tender. Skin thermometry can detect areas of the foot which are at risk of ulcers (“hot spots”). Although skin temperature measurement is considered a good method to predict the development of a foot ulcer, it has not become widely available.
    Recently a group of scientists from University of South Wales, the National Physical Laboratory and Photometrix have made a new camera called Diabetic Foot Prevention System (DFUPS) that can take a special picture of the foot to show the different temperatures of the skin of the foot (thermal map image). The camera uses the technique of infrared thermometry, by which it can detect the heat of the body. In a previous study we have assessed the ability of DFUPS to detect temperature maps in the feet of subjects without diabetes and we showed that this camera is fast and safe.
    We now plan to find out whether regular measurements of the skin foot temperatures with DFUPS in people with diabetes and past history of foot ulcers can identify “hot spots” (early fore-runners of ulcers). We want to test whether patients followed regularly by foot temperature measurements with DFUPS together with routine foot care will develop fewer ulcers compared to patients followed only by routine foot care.

  • REC name

    London - Surrey Borders Research Ethics Committee

  • REC reference

    15/LO/1940

  • Date of REC Opinion

    25 Nov 2015

  • REC opinion

    Favourable Opinion