Improving the design of insoles for diabetic foot disease
- Conditions
- Diabetes with peripheral neurpathyNutritional, Metabolic, EndocrineDiabetes mellitus
- Registration Number
- ISRCTN19805071
- Lead Sponsor
- Glasgow Caledonian University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Validation of computational models in this patient population comparing the predicted plantar pressures to those measured experimentally