Cisneros 2010.

Methods	RCT
Participants	53 people with type 1 and 2 diabetes randomised: intervention 30 vs control 23 Baseline risk for foot ulceration: 35 people had no history of foot ulceration, intervention 21 vs control 14. 16 people had risk 1 (only insensitivity), intervention 6 vs control 10 22 people had risk 2 (insensitivity and plantar overpressure or deformity), intervention 15 vs control 7 6 people had risk 3 (insensitivity and previous ulcers), intervention 3 vs control 3 9 people had risk 4 (insensitivity, previous ulcers and plantar overpressure), intervention 6 vs control 3 Baseline outcome measures: no data provided. Study setting: a unit of the National Health System (SUS) in Porto Alegre, Rio Grande do Sul, Brazil Study setting: community‐based care. Participants were selected from the National Health System (SUS) database Inclusion criteria: diabetes type 1 or 2, presence of neuropathy caused exclusively by diabetes mellitus as evidenced by inability to feel a Semmes‐Weinstein 5.07 monofilament in 2 of 3 of the following sites: digital pulp of the hallux, the head of the first metatarsal and the head of the fifth metatarsal
Interventions	Intervention group: therapeutic education. Content: four 90‐minute group meetings with up to 8 participants, conducted by the researcher. Topics were diabetes complications, disease treatments, inspection and foot hygiene, or choice and use of footwear. Specially prepared games were used as teaching aids with questions on the issue at the end of each meeting, protective footwear, 1 pair at the beginning of the study and another pair after completion of the training programme. The participants could choose between 2 models and different colours. Control group: routine care, instructions on foot care and use of footwear when requested during individual consultations with the researcher. Adherence: of the 30 intervention group participants, 1 withdrew before completion of the education programme and 29 completed the education programme and received protective shoes. Of the 29 participants, 34.5% wore them daily up to 6 hours, 37.9% wore them daily for more than 6 hours and 27.6% did not wear the shoes daily
Outcomes	Primary outcomes: foot ulceration, foot ulcer recurrence Secondary outcomes: not reported
Duration and completion of follow‐up	2 years. 35 participants completed follow‐up: intervention 21 vs control 14
Types of assessment	Inspection of the feet for the occurrence of neuropathic injury during individual consultations with the researcher, held quarterly in the first 18 months and after 2 years' follow‐up
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Methods are not described
Allocation concealment (selection bias)	Unclear risk	Methods are not described
Blinding (performance bias and detection bias) Blinding of outcome assessors	High risk	Both participants and the outcome assessor were not blinded due to the nature of the intervention
Incomplete outcome data (attrition bias) All outcomes	High risk	The proportion of people lost to follow‐up, although balanced between groups, could have induced clinically relevant bias. In I 9 out of 30 participants were censored (30%) and in C 9 out of 23 (39%)
Selective reporting (reporting bias)	Low risk	No study protocol available, but the trial report lists the outcomes of interest in both the methods and the results section
Other bias	Unclear risk	Baseline risk for foot ulceration: the intervention group consisted of more men (intervention 70% vs control 52%), was older (mean age intervention 64.4 years vs control 59.8 years) and appeared to be at higher risk for foot ulceration (risk categories 1 to 4, intervention 20%, 50%, 10%, 20% vs control 43%, 30%, 13%, 13%). Baseline imbalances were not statistically significant and were not adjusted for Co‐interventions: not described Adherence: of the 30 participants, 1 withdrew before completion of the education programme and 29 completed the education programme and received protective shoes