Comparison of insoles prescribed for diabetic patients with and without pedobarograph data
Completed
- Conditions
- DiabetesNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN40423820
- Lead Sponsor
- Derby Hospitals NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 402
Inclusion Criteria
1. Able to walk a minimum of five metres unaided
2. New referral to podiatry
3. Presenting with plantar callus at initial podiatry assessment
4. No previous insole treatment
5. Aged greater than 18 years old
Exclusion Criteria
1. Unable to walk a minimum of five metres unaided
2. Current ulceration
3. Previous insole treatment
4. Non-diabetes related medical problems affecting the lower limbs
5. Lower limb amputation at any level
6. Unclear diabetes diagnosis
7. Congenital foot deformities
8. Charcot foot changes
9. Previous foot or ankle surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate whether custom made insoles for diabetic patients which are guided in design by the pedobarograph data are more effective in reducing skin damage/callus/ulceration than those assessed via current clinical practice.
- Secondary Outcome Measures
Name Time Method To evaluate how neuropathy, ischaemia and deformity affect the outcome of using an insole.