Lincoln 2008.

Methods	RCT
Participants	178 people with diabetes and a newly healed foot ulcer randomised. Intervention 87 vs control 85. Excluded after randomisation: 6 Baseline risk for foot ulceration: Loss of 10 g monofilament stimulus perception: intervention 47% vs control 42% Loss of neuro tip perception: intervention 35% vs control 36% Loss of vibration perception: intervention 68% vs control 62% Absent foot pulses: intervention 20% vs control 28% Baseline outcome measures: History of foot ulcer: all participants Site of previous foot ulcer: fore‐foot: intervention 81% vs control 80%. Mid‐ and hind‐foot: intervention 19% vs control 20% Amputation rate: previous amputation same leg: intervention 20% vs control 12%. Previous amputation other leg: intervention 7% minor, 3% major vs control 6% minor, 3% major No baseline behaviour assessment scores provided Study setting: secondary outpatient care: specialist foot clinic in Nottingham, UK Inclusion criteria: people with newly healed diabetic foot ulcers (ulcer free for 28 days or more), not living in institutions, no history of dementia, no serious medical problems, English speaking or having an English speaking carer, living < 50 miles from the clinic, not included in any other study
Interventions	Intervention group: Single 1‐hour structured foot care education session by 1 of the researchers during a home visit. Content: explanation of the principal causes of foot ulcers, illustrations of foot lesions, advises on avoiding accidental damage, identification personal risk factors, evaluation of footwear Hand‐outs. Content: information about the causes of foot ulcers, foot care and ways to reduce the likelihood of accidents Telephone call 4 weeks after the education session. Content: assessment of the need for clarification and reinforcement of the educational session content Control group: Hand‐outs. Content: information about the causes of foot ulcers, foot care and ways to reduce the likelihood of accidents Adherence: no data provided, but likely that all intervention group people received the 1 hour at home education session
Outcomes	Primary outcomes: ulcer incidence (recurrence), amputation rate Secondary outcomes: patients' behaviour assessment scores
Duration and completion of follow‐up	6 and 12 months; 168 people completed 12 months' follow‐up for primary outcomes. 138 people completed 12 months' follow‐up for secondary outcomes
Types of assessment	Occurrence of new ulcers and amputation rate: hospital and foot clinic records, supported by questionnaires sent to the patient. At 12 months also corroborated by writing to participants' general practitioners Patients' behaviour assessment: questionnaire with 29 items (Nottingham Assessment of Functional Footcare), posted to the patient with a reply‐paid envelope
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The allocation sequence was randomly generated by a computer in advance of the study
Allocation concealment (selection bias)	Low risk	People were allocated after telephoning an independent randomisation centre which held the sequence list
Blinding (performance bias and detection bias) Blinding of outcome assessors	Low risk	Scoring of ulcer incidence and amputation rate was based on hospital and foot clinic records, supported by questionnaires sent to the patient. In case of discrepancy, the records were rechecked by a blinded observer. The success of blinding was not assessed but it was believed to be complete Patients' behaviour assessment score was based on questionnaires that were posted to participants and scored by a researcher who was blinded to participants' group allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	168 of 178 people completed 12 months' follow‐up for primary outcomes. 138 of 178 people completed 12 months' follow‐up for secondary outcomes. Reasons for dropping out were death (n = 10), illness (n = 2), erroneous double‐recruitment (n = 1), withdrawal of consent (n = 1), not fitting the eligibility criteria (n = 1), not returning questionnaires (n = 22) and incompleteness of the questionnaire answers (n = 2) An ITT analysis was performed for primary outcomes only
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	Low risk	Baseline risk for foot ulceration: Loss of 10 g monofilament stimulus perception: intervention 47% vs control 42% Loss of neuro tip perception: intervention 35% vs control 36% Loss of vibration perception: intervention 68% vs control 62% Absent foot pulses: intervention 20% vs control 28% Co‐interventions included regular podiatry and suitable orthoses when appropriate, but no structured education. The clinical care of people in both groups was unaffected by the study Adherence: no data provided, but likely that all intervention group people received the 1 hour at home education session