Idris 2004.

Methods	Single‐centre, prospective, parallel group randomised trial with two arms, and with clinical assessments performed by assessors blinded to randomisation group. All patients attending a dedicated multidisciplinary clinic for the management of established foot ulcers over a 20‐week period were systematically screened for inclusion in a randomised, single‐blinded study. The primary endpoints were healing and glycaemic control within 12 weeks. Secondary endpoints included those which were related to the ulcer (change in ulcer area, amputation), the person (health‐related quality of life, survival, pre‐ and postprandial glucose concentrations, hypoglycaemia) and the process (withdrawals, costs).
Participants	Intended to randomise a total of 50 patients over six months as a pilot for a definitive randomised controlled trial. Inclusion criteria were: people with diabetes over the age of 18, with an active ulcer on or below the malleoli for more than four weeks; cross‐sectional area of the ulcer more than 25 mm2 and less than 2500 mm2; ; able and willing to participate in the study; able and willing (with or without the help of carer) to undertake frequent home blood glucose monitoring, and to administer insulin by injection up to four times daily; HbA1c 7.5% or greater within the preceding two months Exclusion criteria were: those with ulcers penetrating to periosteum, joint capsule or bone, with or without osteomyelitis; those with gangrene; those with chronic renal failure (serum creatinine > 300 µmol/l in the preceding six months); those with any illness or disability which would make it inappropriate to consider a multiple injection regimen; HbA1c < 7.5% within the preceding two months; those with hypoglycaemia unawareness, or recurrent hypoglycaemic attacks on current therapy, or who believe that they will have altered hypoglycaemia awareness on the trial preparation; those with known allergy or sensitivity to any of the preparations to be used; those with malignancy or unlikely to survive for the duration of the study; those being considered for re‐vascularization; those actively involved in any other study
Interventions	Participants were to be randomised to either continue with current hypoglycaemic measures (adjusted by the usual carers in accordance with perceived clinical need) or to an intensive effort to achieve tight control. Both groups were to receive equivalent baseline education and be encouraged to perform regular home blood glucose monitoring.Tight control would be attempted through the intervention of a diabetes specialist nurse and dietitian (each with considerable experience of attempting close glycaemic control in pregnancy), using one‐to‐one education linked to the stepped introduction of basal‐bolus insulin therapy, using glargine (Lantus®) and Novorapid® insulins, adjusted according to the results of home blood glucose monitoring. The aim was to achieve mean preprandial glucose concentrations of between 5 mmol/l and 7 mmol/l and mean postprandial concentrations of between 7 mmol/l and 11 mmol/l.
Outcomes	Out of 200 patients attending the clinic, 188 were ineligible. Of 12 possible recruits, three who had not had a recent HbA1c were excluded when the result was found to be less than 7.5%. Two were judged incapable of complying with an intensive insulin regimen. Four withheld consent, and one was advised by his community nurse to withhold consent. One had an ulcer which became clinically infected on the day before his initial visit, and prior to randomisation. One was successfully recruited and randomised (to the non‐intervention group), and completed the 12 weeks of the study. .
Notes	The study was completed and it was established that it was not feasible to undertake such an intervention in the group of patients managed at that particular specialist clinic. It is possible that the failure to recruit sufficient numbers was peculiar to the centre, despite the size of the population being managed, and that other centres might have been more successful.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Unable to be determined
Allocation concealment (selection bias)	Unclear risk	Unable to be determined
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Unable to be determined
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Unable to be determined
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unable to be determined
Selective reporting (reporting bias)	Unclear risk	Unable to be determined
Other bias	Unclear risk	Unable to be determined