Diabetes with peripheral neurpathy Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
Three interventions are administered to each participant in a randomised, crossover fashion:
1. Standard, total contact insole with modifications for forefoot offloading (control). This is a tradition
Sponsors
Glasgow Caledonian University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forefoot peak plantar pressure, measured using an in-shoe plantar pressure measurement system (Pedar, Novel GmbH, Munich) at a single timepoint immediately after the insoles are provided to the patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Validation of computational models in this patient population comparing the predicted plantar pressures to those measured experimentally | — |
Countries
United Kingdom
Outcome results
None listed