Methods

RCT

Participants

70 patients with type 2 diabetes mellitus ‐ randomised (intervention 38 vs control 32)
Baseline risk for foot ulceration: PVD, intervention 19 vs control 6. Number of foot problems: 'no significant difference between groups'
Baseline outcome measures: 'No significant difference between groups'
Study setting: secondary outpatient care, outpatient clinic in Australia
Inclusion criteria: people with type 2 diabetes mellitus > 3 months and current treatment > 1 month, sub optimal glucose control, BMI ≥ 25, energy fat intake at least 35%, no education in previous 6 months, competence in English language

Interventions

Intervention group:
Normal patient education programme, consisting of 14 hours group patient education (over 3 consecutive days; groups of 8 to 10 people) including 1‐hour lecture and discussion by podiatrist. Content: standard diabetes education, 1 hour on foot care and footwear
4 weekly group patient education sessions of 1.5 to 2.5 hours (total 9 hours), 3 by podiatrist, 1 by psychologist on the base of cognitive motivation theory. Content: recommendations and foot care education and demonstration and practicing foot care procedures

Control group:
Normal patient education programme, consisting of 14 hours group patient education (over 3 consecutive days; groups of 8 to 10 people) including 1‐hour lecture and discussion by podiatrist. Content: standard diabetes education, 1 hour on foot care and footwear

Adherence: not described

Outcomes

Primary outcomes: not reported
Secondary outcomes: foot care knowledge, behaviour assessment score, foot problems requiring treatment

Duration and completion of follow‐up

6 months; 62 people completed follow‐up (intervention 33 vs control 29)

Types of assessment

Outcomes measured by multiple choice questions on knowledge and compliance. Number of questions and range of outcomes not reported

Notes

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

Low risk

Foot care knowledge and foot care routine compliance were assessed with a questionnaire using multiple choice answers. Foot problems were scored by an independent podiatrist, who was not aware of the patients' experimental conditions

Incomplete outcome data (attrition bias)
All outcomes

High risk

62 of 70 people completed 6 months' follow‐up (intervention 33 vs control 29). Reasons for missing outcome data are described and are unlikely to be related to the outcome

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

High risk

Baseline risk for foot ulceration: PVD, intervention 19 vs control 6 (P < 0.05)
Number of foot problems: 'No significant difference between groups'

Co‐interventions were not described

Adherence to the intervention was not described

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

Methods

RCT

Participants

167 people with type 2 diabetes randomised: intervention 55, only RA 55, control 57

Baseline risk for foot ulceration: no data provided
Baseline outcome measures: patients' behaviour assessment scores: intervention 4.7, RA 4.8, control 5.1. Foot care knowledge scores: no significant differences. Self‐efficacy scores: no significant differences
Study setting: 2 community hospital emergency departments near the USA‐Mexico border

Inclusion criteria: people with type 2 diabetes, age 40 years or older, residing within the country, presenting at the emergency department with non‐emergent health problems, not having active foot ulceration or other foot pathology, able to communicate verbally, agreeing on a home visit

Interventions

Intervention group:
Lower extremity amputation risk assessment. Content: use of a monofilament
15‐minute foot self‐care education session by the researcher. Content: information about the patients' risk assessment score, recommendations for foot self‐care based on the individual risk score, a discussion about the barriers to optimal self‐care and an outline of the importance of daily foot self‐care

Risk assessment group: lower extremity amputation risk assessment. Content: use of a monofilament

Control group:

No intervention

Adherence: no data provided, but likely that all intervention group people received the single brief educational session directly after randomisation

Outcomes

Primary outcomes: not reported
Secondary outcomes: foot care knowledge scores, patients' behaviour assessment scores (self‐reported and observed)

Duration and completion of follow‐up

1 month; 141 people completed follow‐up: intervention 47, RA 48, control 46

Types of assessment

Foot care knowledge scores: 5‐item foot care subscale from the Diabetes Knowledge Questionnaire 24
Self‐reported self‐care behaviour: SDSCA questionnaire
Observed self‐care behaviour: self developed 16‐item observation guide

Notes

‐

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

Low risk

The research assistant, who was the outcome assessor, was masked to group assignment

Incomplete outcome data (attrition bias)
All outcomes

High risk

141 of 167 people completed 1‐month follow‐up (intervention 47, RA 48, control 46). Dropout was balanced in numbers across intervention groups, but 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 risk for foot ulceration: no data provided

There were no co‐interventions

Adherence: no data provided, but likely that all intervention group people received the single brief educational session directly after randomisation

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

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

Methods

RCT

Participants

100 people with type 2 diabetes mellitus randomised: intervention 50 vs control 50

Baseline risk for foot ulceration:
Current smoking. intervention 12.5% vs control 16.7%
Mean HbA1c: intervention 7.44 vs control 7.66, P = 0.559
Mean score neuropathy screening questionnaire (0 to 13): intervention 2.46 vs control 2.46, P = 1.00
Mean number of positive sensations of a monofilament on prespecified locations on the foot (0 to 8): intervention 6.06 vs control 5.38, P = 0.215

Baseline outcome measures:

Foot care knowledge scores: intervention 18.65 (SD 2.65) vs control 17.50 (SD 3.14), P = 0.056

Patients' behaviour assessment:

• checking feet: intervention 5.21 vs control 4.52, P = 0.243

• washing feet: intervention 5.17 vs control 5.42, P = 0.572

• applying lotion: intervention 4.54 vs control 4.19, P = 0.560

• wearing shoes and socks: intervention 3.71 vs control 4.92, P = 0.057

Study setting: primary care (mostly indigent) people with type 2 diabetes visiting a podiatrist in 1 of 2 designated community health centres associated with the Indiana University School of Medicine in Indianapolis, Indiana

Inclusion criteria: > 65 years of age, no previous foot or leg amputation, access to a working telephone, able to understand English

Interventions

Intervention group:
Lower extremity amputation risk assessment. Content: use of a monofilament
Foot care videotape. Content: people demonstrating proper foot care
Bag of foot supplies. Content: soap, towel, socks, mirror, toenail clippers, lotion samples, information on smoking cessation and exercise
Hand‐out. Content: foot care instructions
30‐ to 40‐minute individualised education session by research nurse. Content: persuasion to perform foot care + demonstration of content of bag of foot supplies
Reminder checklist. Content: instructions for daily foot care
Weekly reminder telephone calls. Content: persuasion to perform foot care
Care as usual by a podiatrist

Control group:
Lower extremity amputation risk assessment. Content: use of a monofilament
Weekly telephone calls. Content: only outcome assessment
Care as usual by a podiatrist

Adherence: no data provided, but likely that all intervention group people received the single brief educational session directly after randomisation

Outcomes

Primary outcomes: not reported
Secondary outcomes: foot care knowledge scores, patients' self‐reported foot care behaviour scores

Duration and completion of follow‐up

4 weeks; 96 people completed follow‐up intervention 48 vs control 48

Types of assessment

Foot care knowledge: 26 items, with a ''true'', ''false'' or ''don't know'' answer (range 0 to 26)
Behaviour scores: retrospectively self‐reported. Data collection during weekly telephone calls. Foot care behaviours of interest were checking feet daily for injury, washing and drying feet daily, applying lotion to the feet daily, wear socks and shoes, trimming toenails weekly. Results for each item were presented by the mean number of days per week that people adhered to the desired behaviour (range 0 to 7 per item)

Notes

It was originally intended to report changes in 'weekly trimming of toenails', but this was abandoned, as all people were seen by a podiatrist for trimming of their toenails

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Papers with either 'group A' or 'group B' were drawn from an envelope

Allocation concealment (selection bias)

High risk

The envelope was not sealed

Blinding (performance bias and detection bias)
Blinding of outcome assessors

High risk

Outcomes were assessed by the research nurse, who also performed the educational intervention

Incomplete outcome data (attrition bias)
All outcomes

High risk

96 of 100 people completed 4 weeks' follow‐up (intervention 48 vs control 48)
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 risk for foot ulceration:
Current smoking. intervention 12.5% vs control 16.7%
Mean HbA1c: intervention 7.44 vs control 7.66, P = 0.559
Mean score neuropathy screening questionnaire (0 to 13): intervention 2.46 vs control 2.46, P = 1.00
Mean number of positive sensations of a monofilament on prespecified locations on the foot (0 to 8): intervention 6.06 vs control 5.38, P = 0.215

Co‐interventions were not described

Adherence: no data provided, but likely that all intervention group people received the single brief educational session directly after randomisation

Methods

RCT

Participants

50 people with diabetes mellitus randomised: intervention 23 vs control 27

Baseline risk for foot ulceration: no data provided
Study setting: secondary outpatient care in the USA

Inclusion criteria: diabetes duration at least 5 years (unclear which type of diabetes), no frank pathology, entering weekly hospital diabetes programme

Interventions

Intervention group:
1‐week patient education session. Content: education and guidance (unclear by whom) to assist people in achieving higher levels of general diabetes control
Instructional videotape with supplementary explanation from an instructor. Content: usual teaching on foot care
Additional hands‐on learning sessions during the same week. Content: actual foot washing, inspection, assessment, demonstration of care of corns and callus, toenail cutting, identification of potential foot problems, evaluation foot care
Patient education kit. Content: buff pads and mirror
Daily foot check sheets. Content: encouragement to perform daily foot inspection

Control group:
1‐week patient education session. Content: education and guidance (unclear by whom) to assist people in achieving higher levels of general diabetes control
Instructional videotape with supplementary explanation from an instructor. Content: usual teaching on foot care
Daily foot check sheets. Content: encouragement to daily foot inspection

Adherence: no data provided

Outcomes

Primary outcomes: none reported
Secondary outcomes: foot status, foot care knowledge scores, behaviour assessment

Duration and completion of follow‐up

6 months; 30 people completed follow‐up: intervention 15 vs control 15

Types of assessment

Foot status assessment: 67 items
Foot care knowledge assessment: 12‐item test
Behaviour assessment: daily foot check sheets

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

People were allocated to intervention or control on the basis of the week that they entered the diabetes program. The experimental intervention group was developed similarly from the control group on alternate weeks
Quote: "A random selection process determined whether the control or the experimental [intervention] group would begin the study"

Allocation concealment (selection bias)

High risk

Alternation is not an adequate method of allocation concealment

Blinding (performance bias and detection bias)
Blinding of outcome assessors

Unclear risk

No information provided

Incomplete outcome data (attrition bias)
All outcomes

High risk

30 of 50 people completed 6 months' follow‐up (intervention 15 vs control 15). Reasons for dropping out were death (n = 2), not wanting to make an appointment at the scheduled time and moving without leaving a forwarding address (numbers not reported)
No ITT analyses were undertaken

Selective reporting (reporting bias)

Low risk

Yes. 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: no data provided
Co‐interventions were not described
Adherence: no data provided

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

Methods

RCT

Participants

227 people with diabetes mellitus and foot infection, ulceration or prior amputation ‐ randomised. 203 people included: intervention 103 vs control 100.

Baseline risk for foot ulceration: although described as 'not significant', prior vascular reconstruction higher in control and incidence of foot callus higher in intervention (P < 0.05). No significant differences in foot deformities, neuropathy, gangrene, prior amputation or ulcer and level of distal pulses

Study setting: secondary outpatient care, podiatric or vascular surgery care in the USA

Inclusion criteria: people with diabetes (unclear which type) with foot infection, ulceration or prior amputation referred for podiatry or vascular surgery

Interventions

Intervention group:
1‐hour group patient education with slides given by podiatrist and set of patient instructions. Content: slides of infected diabetic feet and amputated diabetic limbs, simple set of patient instructions for diabetic foot care
Routine patient education. Content: routine diabetic teaching on diet, weight, exercise and medication

Control group:

Routine patient education. Content: routine diabetic teaching on diet, weight, exercise and medication

Adherence: no data provided

Outcomes

Primary outcomes: ulcer incidence, incidence of infections, amputation rate
Secondary outcomes: none

Duration and completion of follow‐up

Intervention mean 12 months, median 13.2 months (range 1 to 26 months) vs control mean 8 months, median 9.2 months (range 1 to 26 months); 182 people completed follow‐up: intervention 90 vs control 92

Types of assessment

No information provided

Notes

Unit of randomisation: individual people. Unit of analyses: separate limbs

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Quote: "Patients were randomised into two groups based upon the odd or even last digit of their Social Security number"

Allocation concealment (selection bias)

High risk

Sequence generation was based upon the last digit of the persons social security number

Blinding (performance bias and detection bias)
Blinding of outcome assessors

Unclear risk

No information provided

Incomplete outcome data (attrition bias)
All outcomes

High risk

182 of 227 people completed follow‐up (intervention 90 vs control 92). Reasons for dropping out were not fitting the eligibility criteria (n = 24), death (n = 13) and unspecified (n = 8)

No ITT analyses were undertaken

Selective reporting (reporting bias)

Low risk

No study protocol available, but the trial report listed the outcomes of interest in both the methods and the results section

Other bias

Unclear risk

Baseline risk for foot ulceration: although described as 'not significant', prior vascular reconstruction higher in control and incidence of foot callus higher in intervention (P < 0.05). No significant differences in foot deformities, neuropathy, gangrene, prior amputation or ulcer and level of distal pulses
Co‐interventions were not described
Adherence: no data provided

Methods

RCT

Participants

532 people with diabetes mellitus randomised intervention 263 vs control 269

Baseline risk for foot ulceration: no data provided
Study setting: primary care, academic general medicine clinic in the USA

Inclusion criteria: either 2 fasting blood glucose levels > 130 mg/dL or 1 > 150 mg/dL or 2‐hour value > 250 mg/dL, able to perform 2 basic self‐care tasks, no psychiatric or terminal illness, under care of an internal medicine resident, informed consent

Interventions

Intervention group:
Diagnosis of educational needs according to protocol
Patient education in appropriate modules of instruction by nurses and dieticians by group education using lecture, discussion and/or audio‐visual materials, demonstration, return demonstration and feedback, goal setting, and written contract on goals. Content (depending on individual educational needs): understanding diabetes, acute complications, antidiabetic medication, antihypertensive medication, diet and activity, foot care and urine testing
Reinforcement by phone contact 2 and 6 weeks after instruction

Control group:

Usual care. Content: including routine education

Adherence: 139 of 208 (67%) people needing instruction on foot care completed this

Outcomes

Primary outcomes: none reported
Secondary outcomes: level of foot care knowledge

Duration and completion of follow‐up

Median interval between instruction and follow‐up measurement 11.8 to 14.3 months; 275 people completed follow‐up: intervention 135 vs control 140

Types of assessment

Level of foot care knowledge: nurse‐administered patient history following predefined learning objectives

Notes

Knowledge objectives unclear

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

High risk

Assessments were not conducted by personnel who were blind to subjects' experimental condition

Incomplete outcome data (attrition bias)
All outcomes

High risk

275 of 532 people completed follow‐up (intervention 135 vs control 140). Reasons for dropping out were death (n = 30), physical or psychological incapacitation (n = 43), transfer to a senior staff physician (n = 32), relocation (n = 13), work conflict (n = 24), personal reasons (n = 45), failure to keep appointments (n = 11) and lost contact (n = 58)
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

High risk

Baseline risk for foot ulceration: no data provided
Co‐interventions were not described
Adherence: 139 of 208 (67%) people needing instruction on foot care completed this

Methods

RCT

Participants

471 people with diabetes mellitus randomised intervention 228 vs control 243

Baseline risk for foot ulceration: no data provided
Study setting: community‐based care

Inclusion criteria: identified as diabetic inpatient of participating hospitals (unclear which type of diabetes), age < 65 years (at begin of study), no terminal illness, physician approval

Interventions

Intervention group:
Up to 12 home patient education sessions, provided by nurses, who attended special 4‐day intensive course in diabetes self care. Content: according to judgement of nurse, tailored to patient self management needs, which were defined with 100 short answer and yes/no questions

Control group:

Usual care. Content: not specified

Adherence: no data provided

Outcomes

Primary outcomes: none
Secondary outcomes: foot appearance score, foot care knowledge, behaviour assessment score

Duration and completion of follow‐up

6 months; 373 people completed follow‐up: intervention 180 vs control 193

Types of assessment

Foot appearance assessment: nurse scored a 16‐item checklist
Foot care knowledge assessment: 70 multiple‐choice questions, covering 4 areas of which foot care was 1
Behaviour assessment: skills assessed by nurse

Notes

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

Low risk

The staff nurses, who were the outcome assessors, were not aware of subject assignment at the time of the follow‐up visit

Incomplete outcome data (attrition bias)
All outcomes

High risk

373 of 471 people completed follow‐up (intervention 180 vs control 193). Reasons for dropping out were deaths, violations of the protocol (such as an excessive number of home visits) and unspecified
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 risk for foot ulceration: no data provided
Co‐interventions were not described
Adherence: no data provided

Methods

RCT

Participants

530 people with diabetes mellitus randomised, intervention 267 vs control 263Baseline risk for foot ulceration: no data provided

Baseline outcome measures:
Foot care knowledge score: intervention 26.7 (SD 11.4) vs control 26.1 (SD 11.8)
Self‐care behaviour assessment score: intervention 5.4 (SD 2.8) vs control 5.3 (SD 2.6)
Callosities: intervention 18.5% calcaneal region, 54.5% other regions; control 16.8% calcaneal region, 51.3% other regions
Diameter of greatest callosity: intervention calcaneal region (n = 49) 40.5 mm (SD 30.8 mm), other regions (n = 141) 16.6 mm (SD 10.2 mm); control calcaneal region (n = 55) 30.6 mm (SD 28.5 mm), other regions (n = 138) 15.2 mm (SD 9.8 mm)
Podiatrist visit: intervention 12.4% in previous year, 73.4% never before vs control 10.4% in previous year, 76.1% never before
Foot examination by physician in previous year: intervention 36.7% routinely, 9.5% following complaints vs control 46.4% routinely, 12.3% following complaints

Study setting: community‐based care in the vicinity of Turku, Finland

Inclusion criteria: included in the national drug imbursement register for receiving antidiabetic treatment, no obvious need for podiatry, no visit with podiatrist in previous 6 months, age between 10 to 79 years

Interventions

Intervention group:
45 minutes' individual patient education. Content: education on use of proper footwear, daily hygiene, cutting of toenails, use of emollient cream, avoidance of high‐risk situations and foot gymnastics
Podiatric care visits (to 1 of 3 participating podiatrists) of 30 to 60 minutes' duration as necessary. Content: preventive podiatric care as debridement of callus, preparation of insoles, treatment of ingrowing toenails and guidance for foot gymnastics

Control group:

Written information. Content: instructions on foot care

Adherence: intervention mean number of podiatry visits 4.7 in first year. After first and before seventh follow‐up year at least 1 podiatry visit in 82.3% of people in intervention and in 49.7% in control

Outcomes

Primary outcomes: amputation rate, ulcer incidence
Secondary outcomes: callus development, foot care knowledge, behaviour assessment scores

Duration and completion of follow‐up

1 and 7 years; 459 completed 1 year of follow‐up: intervention 233 vs control 226
332 completed 7 years of follow‐up: intervention 169 vs control 163

Types of assessment

Callus diameter in millimetres.
Knowledge score: 19 three‐choice questions of which 1 or 2 correct answers: correct = 1, unknown = 0, incorrect = 1 (total score range 0 to 57)
Behaviour assessment score: range 0 to 12

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Randomisation was performed separately for men and women and for people below and above 20 years of age. Method of randomisation not described

Allocation concealment (selection bias)

Unclear risk

No information provided

Blinding (performance bias and detection bias)
Blinding of outcome assessors

Unclear risk

The outcome assessor was blinded to the baseline characteristics, but no further information on blinding to the group allocation is provided

Incomplete outcome data (attrition bias)
All outcomes

High risk

Follow‐up was completed by only 63% of people in the intervention group and 62% of people in the control group at 7 years
No ITT analysis 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

High risk

Baseline risk for foot ulceration: no data provided
Adherence: intervention mean number of podiatry visits 4.7 in first year. After first and before seventh follow‐up year at least 1 podiatry visit in 82.3% of people in intervention and in 49.7% in control
Co‐interventions: podiatry care was provided to intervention group people only