Table 1.
Entry criteria assessed in substudy 1
| Criteria | Notation | Description |
| Inclusion | IC1 | Male or female aged ≥18 years |
| IC2 | Type 1 or type 2 diabetes mellitus for more than 1 year with an HbA1c ≥60 mmol/mol | |
| IC3 | Incident foot ulcer(s) located below the level of the malleoli | |
| IC4 | Able and willing to undertake home blood glucose monitoring and administer insulin up to four times daily under the supervision of the diabetes nurse specialist | |
| IC5 | Able and willing to provide informed consent to participate in the study | |
| Exclusion | EC1 | Ulcers with radiological features of osteomyelitis |
| EC2 | Significant peripheral vascular disease under consideration for re-vascularisation | |
| EC3 | Significant bone deformity as determined by the investigator which may delay wound healing | |
| EC4 | Non-adherence to standard care | |
| EC5 | Any other disease or condition in the opinion of the investigator could make them unsuitable for entry | |
| Full | FC | All inclusion criterion satisfied (5-Yes) and all exclusion criterion satisfied (5-No) |
EC, exclusion criteria;FC, full criteria; HbA1c, glycosylated haemoglobin; IC, inclusion criteria.