SLIPSTREAM Version 1.0.0

  • Research type

    Research Study

  • Full title

    Shear Load In-shoe Plantar Sensing/sTRain analysEs And Mapping in diabetic foot ulcers: SLIPSTREAM

  • IRAS ID

    291873

  • Contact name

    David A Russell

  • Contact email

    davidrussell1@nhs.net

  • Sponsor organisation

    Leeds Teaching Hospitals Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT05687643

  • Duration of Study in the UK

    0 years, 9 months, 3 days

  • Research summary

    Four hundred and sixty-three million adults live with diabetes globally, with prevalence expected to rise to 700 million by 2045. Up to one quarter will develop a diabetic foot ulcer, with 5-8% of these requiring a major amputation within 1 year. Ulceration is a multifactorial process with peripheral neuropathy and arterial disease playing central roles. Neuropathy leads to the loss of protective sensation and development of abnormal foot architecture. Loss of protective sensation results in undetected, repetitive trauma to the foot. This effect is compounded by the development of structural abnormalities, which increases plantar stress leading to inflammation and tissue breakdown. Plantar pressure forms the vertical component of the load experienced during normal gait. Plantar shear stress (PSS) forms the tangential component of plantar load. It acts parallel to the foot, usually caused by friction between the foot-surface interface.

    PSS and its relationship with ulcer formation is poorly understood. This research aims to investigate this relationship using two technologies. ‘STrain Analysis Mapping of the Plantar surface (STAMP)’ is a novel method to measure strain patterns on the plantar surface of the foot. STAMP utilises digital image correlation to track the deformation of a plastically deformable insole following a trial of walking. ‘Shear Load Inductive Plantar Sensing’ (SLIPS) is a novel system designed to measure ‘in-shoe’ PSS and plantar pressure. SLIPS is a wearable sensing insole which integrates 64 tri-axis soft force sensors, simultaneously measuring both plantar pressure and PSS.

    This research will compare plantar strain, PSS and plantar pressure in patients with diabetes with a previous plantar ulcer, and patients with diabetes with low risk for ulceration.

  • REC name

    Yorkshire & The Humber - Leeds West Research Ethics Committee

  • REC reference

    22/YH/0007

  • Date of REC Opinion

    2 Feb 2022

  • REC opinion

    Further Information Favourable Opinion