Diabetes Nutritional, Metabolic, Endocrine Diabetic Foot
Conditions
Interventions
Participants are randomly allocated to one of two groups using computerised block randomisation.
Group 1: Traditional Design and Manufacture Process:
The geometry of t
varied hardness forefoot sections, cut outs, cut and fills and metatarsal bars material density used in additions will vary dependent on individual requirements. Top covers may be used where multiple
Sponsors
University of Salford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 40 and 85 years 2. Have diabetes diagnosed by a medical practitioner 3. Have modular or bespoke (non standard) footwear provided by the orthotics department 4. Have all normal foot structures present 5. Be able to walk without a stick for 100 metres 6. Have sensory neuropathy as assessed by 10mg monofilament and vibratory perception at 3 of 10 sites on the foot and ankle 7. Have detectable pulse in foot and ankle (palpation or Doppler) 8. Must be capable of providing informed consent to participate
Exclusion criteria
Exclusion criteria: 1. Have had prior foot or ankle surgery 2. Have had prior major injuries to lower limb (e.g. fractures requiring internal fixation, skin grafts) 3. Have prior or active chronic foot or leg ulceration and without episode of ulceration within last 2 years. 4. Require heel pressure reduction intervention 5. Have had prescription foot orthoses via the orthotics department in the last 12 months 6. Co-morbidities (ischemia, renal, charcot arthorpathy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plantar pressure will be measured using an in shoe plantar pressure system which captures data concerning the distribution of weight across the bottom of the foot whilst wearing the orthotic insoles at baseline, 1, 2, 5 and 8 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient outcomes measured using validated questionnaires (EQ5D, ICECAP, FHSQ) at months 0, 1, 2, 5 and 8. 2. Compliance measured via telephone check-ups at months 3, 4, 5, 6, 7 and 8 3. Organisational outcomes measured using service data (number of appointments, number of foot wear and orthotic products supplied) at months 0 - 8 4. Service use data measured via a clinical service receipt inventory at months, 0 - 8 | — |
Countries
England, United Kingdom
Outcome results
None listed