Specialty: Musculoskeletal disorders, Primary sub-specialty: Non-pharmacological Interventions
Conditions
Interventions
Participants are randomised to one of two groups. Those in the first group receive the intervention insole designed to reduce peak plantar pressure in addition to usual care (Intervention) while the p
study sites and by previous ulceration status. The randomised allocations will be computer-generated.
Intervention group: Optimised custom insole in standardised house shoe with usual
Sponsors
Plymouth University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of type 1 or 2 diabetes as confirmed by medical records 2. Aged over 18 years 3. Identified clinical need for offloading insoles by podiatrist 4. Neuropathic (sensory peripheral diabetic neuropathy) 5. Palpable pedal foot pulses 6. Able and willing to comply with all trial requirement
Exclusion criteria
Exclusion criteria: 1. Any other significant disease or disorder which, in the opinion of the PI, may put the participant at risk of health deterioration, such as falls, because of their involvement in the trial 2. Non healing foot ulcer at another site that requires targeted off-loading 3. Unable to walk five metres with/without walking aid 4. Unable to stand on either leg independently for 10 seconds (+/- chair aid to assist in balance) 5. Lacking capacity or unwilling to give consent 6. Already wearing existing insoles that are clinically appropriate 7. Peripheral vascular disease (non-re-constructible vascular disease as determined by arterial duplex) 8. Unwilling to wear therapeutic footwear 9. Gross foot deformity e.g. charcot foot or fixed rear foot deformity 10. Unable to provide adequate consent to undertake the trial procedures 11. Major amputation of part of the foot
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the feasibility and acceptability of the trial procedures through the 12 month trial period is measured using: 1.1. Numbers of eligible participants from the target population 1.2. Recruitment and retention rates of eligible participants through the trial 1.3. Willingness of participants to be randomised 1.4. Assess the pragmatism of delivering the insole intervention in the proposed settings by qualitative interviews 1.5. Variation and fidelity in the delivery of the intervention in each. A fidelity checklist will evaluate the adherence by the treating podiatrists to the standardised protocol of intervention delivery. 1.6. Completeness of data sets/outcome measures 1.7. Success of the blinding by using the Bang Index | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the appropriateness and performance of outcome measures, to inform the selection of primary outcome for the main RCT and refine the secondary outcomes by measuring at baseline, three months, six months and 12 month follow up: 1.1. Incidence of plantar foot ulceration by using photograph status of the feet 1.2. Mean Peak plantar pressure (PPP) by using F-Scan in-shoe pressure measurement 1.3. Extent of participant self-foot care by using Nottingham Assessment of Functional Footcare questionnaire; 1.4. Extent of participant activity as by using International Physical Activity Questionnaire 1.5. Extent of participant adherence to wearing the insole and footwear by using data logger 1.6. To inform a power calculation for sample size estimate for the main RCT using distributional properties and standard deviations arising from differences between the intervention and control arm | — |
Countries
England, United Kingdom
Outcome results
None listed