Low Cost bespoke insoles - version 1
Research type
Research Study
Full title
Automated creation of low-cost insoles for the prevention of diabetic foot ulcers
IRAS ID
182286
Contact name
Roozbeh Naemi
Contact email
Sponsor organisation
Staffordshire University
Duration of Study in the UK
0 years, 3 months, 29 days
Research summary
The treatment cost of diabetic foot ulceration to the NHS is estimated at £650m/annum, a substantial financial burden at a time when the NHS is under pressure to reduce costs.
There is an association between elevated peak plantar pressure and the development of diabetic foot ulceration. Reducing plantar pressures is therefore crucial in preventing ulceration, particularly in neuropathic (nerve damaged) feet where plantar loads are increased. Insoles and therapeutic footwear are the clinically recommended method of reducing pressure under the diabetic foot. However there are challenges that need to be overcome for insoles to be effective in reducing diabetic foot ulceration risk; for instance:• Insoles can be too bulky to fit within retail footwear.
• At risk patients can wait months; anything from 3 to 18, for bespoke footwear and insoles to be made, often without an acceptable alternative.
• Current methods are expensive, requiring specialist equipment casting/scanning, Podiatrist's expertise (2 to 3 visits at £50/visit), and insole manufacture (around £120-£250).In collaboration with commercial partners (Cadscan, Recreus and Gyrobot) and Staffordshire University we have developed an automated system to produce a new low cost instant insole that will overcome the limitations of traditional insoles. The system comprises a new, low-cost 3D scanner to capture 3D foot imagery, software that determines the most effective intervention for the profile, and a low-cost 3D printer that can manufacture comfortable, clinically effective custom insoles within 4 hours.
The aim of this repeated measure observational study is to compare the new 3-D insole with a standard insole to see which is best at reducing peak pressure in people with diabetes and neuropathy. Participants will be recruited from two sites. Data will be collected in a single session.
The results will be used to inform insole development and provide evidence of proof of concept.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
16/SW/0321
Date of REC Opinion
9 Dec 2016
REC opinion
Favourable Opinion