Insoles to Ease Pressure (INSTEP) Study inclusion and exclusion criteria
| Inclusion criteria | Exclusion criteria |
| Confirmed diagnosis of type 1 or type 2 diabetes as confirmed by medical records | Any other significant disease or disorder* |
| Aged over 18 years | Non-healing foot ulcer at another site that requires targeted offloading |
| Identified clinical need for offloading insoles by podiatrist | Unable to walk 5 m with/without walking aid |
| Neuropathic (sensory peripheral diabetic neuropathy defined as insensitivity of a 5.07/10 g monofilament16) | Unable to stand on either leg independently for 10 s (±chair aid to assist in balance) |
| Palpable pedal foot pulses | Lacking capacity or unwilling to give consent |
| Able and willing to comply with all trial requirements | Already wearing existing insoles that are clinically appropriate |
| Peripheral vascular disease (non-reconstructible vascular disease as determined by arterial duplex) | |
| Unwilling to wear therapeutic footwear | |
| Gross foot deformity, for example, Charcot foot or fixed rear foot deformity | |
| Unable to provide adequate consent to undertake the trial procedures | |
| Major amputation of part of the foot |
↵*Which, in the opinion of the principal investigator (PI), may put the participant at risk of health deterioration, such as falls.