Biomechanical & Activity Factors in Diabetic foot Ulceration (ver1.0)

• Research type

  Research Study

• Full title

  A Novel Technique for Evaluating Patterns of Local Biomechanical and Activity-based Factors in People at High Risk of Diabetic Foot Ulceration

• IRAS ID

  139957

• Contact name

  Gordon Hendry

• Contact email

  gordon.hendry@gcu.ac.uk

• Sponsor organisation

  Glasgow Caledonian University

• Clinicaltrials.gov Identifier

  GN14DI049, NHS GG&C R&D Reference Number

• Research summary

  Diabetic foot ulceration (DFU) is a devastating complication of diabetes that can lead to amputation and early death, and costs the tax payer around £9 billion annually [1]. Both external (e.g. footwear, activity) and internal (e.g. deformity, neuropathy) factors influence DFU risk [2]. Associations between plantar foot pressures and DFU are well established in the literature [3]. However, the effects of cumulative loading (combination of activity and pressure) may also be significant [4]. Intrinsic factors such as plantar soft tissue (PST) properties may also be important [5], since changes may reduce a tissues ability to cope with normal levels of stress during daily activities. At present no clear conclusions about the impact of biomechanical factors can be drawn due to heterogenicity of current studies. Furthermore, no methods exist to measure PSTs during walking. Therefore, we aim to assess local biomechanical and activity-based parameters during walking in diabetic neuropathic patients with and without previous DFU. We hypothesise that significant between-group differences will be found.
  To test our hypothesis a preliminary study will be carried out in 10 diabetic participants to determine the reliability of a novel in-shoe ultrasound method for measurement of PST properties during gait. The main study will involve 60 diabetic neuropathic adults, with (DPNU, n=30) and without (DPN, n=30) DFU history, and 30 matched controls (HC). Local biomechanical and activity parameters (plantar soft tissue thickness, strain and stiffness; plantar pressure parameters;and activity measures) will be evaluated. Group (HC, DPN, DPNU) differences will be analysed using appropriate inferential statistics. Correlation statistics may also be conducted where appropriate. Findings should increase our understanding of the complex pathways that lead to DFU, and hence may have the potential to inform future clinical decision making.

  1. Diabetes UK, 2012
  2. Reiber, Vileikyte 1999
  3. Patry 2013
  4. Maluf, Mueller 2003
  5. Thomas, Patil et al. 2003

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  14/EM/1143

• Date of REC Opinion

  9 Sep 2014

• REC opinion

  Favourable Opinion