Optimisation of custom insoles for pressure relief in patients with diabetes via finite element modelling

Glasgow Caledonian University0 sites20 target enrollmentAugust 21, 2015

Overview

No summary available.

Registry

who.int

Start Date

August 21, 2015

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. 18\-75 years of age
•2\. Shoe size 5\-11 (UK)
•3\. Able to walk 300m (including \~20m barefoot) safely
•4\. Diabetes mellitus Type 1 or 2 with duration \=10 years
•5\. Diabetic peripheral neuropathy defined as loss of sensation to 10g monofilament test at one or more forefoot sites
•6\. Elevated barefoot plantar pressure (\>700kPa) measured at the forefoot during walking

•1\. Lower limb, foot or digital amputation (at a level proximal to the distal IPJ, or involving the hallux)
•2\. Severe callus (callus will not result in exclusion if it has been reduced to a level that does not affect sensation of underlying skin)
•3\. History of medical conditions, injuries or surgical procedures that significantly influence gait, or which cause pain on walking (including Charcot)
•4\. Severe foot deformity or reduction in ROM that result in abnormal gait or preclude good fit of study shoe (including Charcot)
•5\. Severe concurrent medical condition that would prevent participation in study procedures (e.g. severe cardiac/pulmonary condition that precludes activity) or with life expectancy \= 3 months.
•6\. Pregnancy