SMARTPIF - Diabetic insole design

• Research type

  Research Study

• Full title

  SMARTPIF - Diabetic insole design

• IRAS ID

  115521

• Contact name

  Stephen Preece

• Contact email

  s.preece@salford.ac.uk

• Sponsor organisation

  University of Salford

• Eudract number

  N/A

• Research summary

  Foot ulceration is a common problem which affects people with diabetes. If left untreated, serious infection can develop which, in some cases, has the potential to lead to amputation. Elevated plantar pressure has been shown to be a risk factor for the development of foot ulceration. Given the risks associated with elevated plantar pressures, specifically designed insoles are used to reduce pressures under the foot during walking in patients with diabetes. Insoles can be considered to be either: off-the-shelf or custom made. Off-the-shelf insoles are manufactured from a thick cushioning material and often incorporate additional material to change surface shape. This can make the insoles very thick. The alternative, custom made insoles, are made from a cast of the foot and are often preferred by patients due to their reduced thickness.
  In order to design customized insoles for patients with diabetes, it is necessary to have a precise understanding the effect of varying different aspects of insole shape. Furthermore, clinicians must understand how to customize insoles based on an individual patient’s foot characteristics/biomechanics. Given these requirements, there is a need for a knowledge-based system which could be used to predict the best insole design from an input of patient-specific clinical/biomechanical data. We propose to develop such a system with a two phased approach. In the first phase we will study the effect of a number of insole design characteristics on plantar pressure across a range of patients who suffer with diabetes and neuropathy. In the second phase we will investigate whether specific clinical/biomechanical variables, such as pressure data, 3D footscan data and joint mobility, could predict the optimal insole design for any given patient.

• REC name

  North West - Greater Manchester East Research Ethics Committee

• REC reference

  13/NW/0331

• Date of REC Opinion

  24 May 2013

• REC opinion

  Favourable Opinion