Topic: Diabetes Research Network
Conditions
Interventions
Once patients are recruited to the study they will be randomly assigned to one of two groups using random number generating software (1 - intervention or 2 - control):
1. Intervention
Sponsors
Manchester Metropolitan University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed with Type 1 or 2 diabetes 2. A history of previous ulceration on the weight-bearing surface of the foot 3. Presence of neuropathy (defined by any loss of sensation) 4. Ability to walk independently for approx. 100 metres (i.e., without use of wheelchair, walking stick or personal assistance) 5. Aged >18 years 6. Able to understand all of the study requirements and have a life expectancy greater than the study duration Target Gender: Male & Female
Exclusion criteria
Exclusion criteria: 1. Active foot ulcer 2. In-shoe orthotics consisting of non-compressible materials 3. Presence of severe ischaemia for either foot defined by complete absence of foot pulses and ankle-brachial pressure index 40
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Foot ulceration. The feet will be checked for ulceration every month for 18 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed