Corbett 2003.

Methods	RCT
Participants	40 people with type 2 diabetes mellitus randomised: intervention 20 vs control 20 Baseline risk for foot ulceration: 70% had loss of protective sensation 67% had impaired lower extremity circulation 50% had a foot deformity Foot risk assessment: no significant differences between groups Baseline outcome measures: no significant differences between groups Study setting: community‐based care, people with type 2 diabetes mellitus admitted to home care in the USA Inclusion criteria: physically and mentally able to participate, able to read and understand English, age 18 years or older, no lower‐extremity ulcer, no history of lower‐extremity amputation
Interventions	Intervention group: 10 to 20 minutes' individualised patient education including verbal and written instructions according to participants' risk factors and foot care knowledge, self‐efficacy and reported self‐care behaviour by research nurse. Content: foot care education topics: individual risk factors, washing and drying feet, toenail care, footwear, moisturising feet, reportable foot problems. If desired: demonstration of nail trimming and problem‐solving discussion to discover alternative care solutions Control group: No intervention Adherence: 19 of 20 intervention group people attended the single education session
Outcomes	Primary outcomes: not reported Secondary outcomes: foot care knowledge score, foot care practice score, patients' self confidence scores
Duration and completion of follow‐up	6 weeks after the intervention (people were enrolled in the study already 6 weeks prior to the intervention to ensure proper baseline measurements); 35 people completed follow‐up intervention 19 vs control 16
Types of assessment	Foot care knowledge assessment: 7 questions with 4 choices; foot care practice assessment: 7 questions with 4 choices; patients' self confidence assessment: 7 aspects of foot care rated on a 6‐point scale
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomly drawing labelled consent forms, the sequence having been generated by shuffling
Allocation concealment (selection bias)	Low risk	Consent form labels were covered by opaque stickers and randomly shuffled
Blinding (performance bias and detection bias) Blinding of outcome assessors	Unclear risk	No information provided
Incomplete outcome data (attrition bias) All outcomes	High risk	35 of 40 people completed follow‐up (intervention 19 vs control 16). Reasons for missing data were not reported No ITT analyses were undertaken
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 foot risk assessment: 'no significant differences between groups' Co‐interventions were not described Adherence: 19 of 20 intervention group people attended the single education session