Bloomgarden 1987.

Methods	RCT
Participants	749 insulin‐treated people with diabetes mellitus randomised: 345 consented to participate: intervention 165 vs control 180 Baseline risk for foot ulceration: 146 people had no foot lesion at initial evaluation, intervention 83 vs control 63 100 people had callus, nail dystrophy or fungal infection at initial evaluation, intervention 37 vs control 63 20 people had an ulcer or amputation at initial evaluation, intervention 7 vs control 13 Study setting: primary care, diabetes clinic in the USA Inclusion criteria: insulin‐treated diabetes mellitus (unclear which type of diabetes)
Interventions	I: 9 group patient education sessions by nurse educator and nutritionist using film and card games and individual instruction. Content: 1 group session of education on foot care and skin hygiene, the other sessions on understanding diabetes, basic nutrition, weight loss, food purchasing, meal planning, insulin administration, emergencies, risk factors for macrovascular disease and individual diet instruction C: usual care. Content: not specified Adherence: 82 (50%) intervention group people completed 7 or more educational group sessions
Outcomes	Primary outcomes: ulcer or amputations Secondary outcomes: callus, nail dystrophy or fungal infection, behaviour assessment score
Duration and completion of follow‐up	Intervention 1.6 ± 0.3 years vs control 1.5 ± 0.3 years; 266 people completed follow‐up: intervention 127 vs control 139
Types of assessment	Behaviour assessment score: 7 questions of which 1 on foot care
Notes	The reported outcome data on knowledge scores are not included in this review, because the assessment tool only included questions about diabetes in general, but not on foot care
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information provided
Allocation concealment (selection bias)	Unclear risk	No information provided
Blinding (performance bias and detection bias) Blinding of outcome assessors	Unclear risk	No information provided
Incomplete outcome data (attrition bias) All outcomes	High risk	266 of 345 people completed follow‐up (intervention 127 vs control 139). Reasons for missing outcome data are described and are unlikely to be related to the outcome. Note: 749 people were originally randomised, but 193 did not attend the clinic during the period of the study and 211 of those who did attend to the clinic declined to participate, leaving only 345 study subjects No ITT analyses were undertaken
Selective reporting (reporting bias)	Unclear risk	Unclear. No study protocol available. The outcomes ulcer and amputation incidence, callus, nail dystrophy, fungal infection and behaviour assessment score were not prespecified in the methods section of the study report, but this is more likely to be a result of insufficient rather than selective reporting
Other bias	High risk	Baseline risk for foot ulceration: 146 people had no foot lesion at initial evaluation, intervention 83 vs control 63 100 people had callus, nail dystrophy or fungal infection at initial evaluation, intervention 37 vs control 63 20 people had an ulcer or amputation at initial evaluation, intervention 7 vs control 13 Co‐interventions were not described Adherence: 82 (50%) intervention group people completed 7 or more educational group sessions