Jeffcoate 2009.

Methods	RCT Setting: Hospital, 9 centres Country: UK Duration of follow‐up: 24 weeks Duration of treatment: 24 weeks or until healing Funding source: Not‐for‐profit Unit of analysis: Participant
Participants	317 participants Inclusion criteria: Type 1 or 2 diabetes; 18 years of age or older; a foot ulcer present for at least 6 weeks with a cross‐sectional area of between 25 and 2500 mm²; able and willing to give informed consent; reasonably accessible by car to the hospital base; under routine review by the multidisciplinary clinic. Exclusion criteria: Those with a known allergy to any of the trial preparations (including iodine); any ulcer on either foot extending to tendon, periosteum, or bone, infection of bone, soft‐tissue infection requiring treatment with systemic antibiotics; an ulcer on a limb being considered for revascularisation; those chosen for management with a non‐removable cast without a dressing window; gangrene on the affected foot; eschar that was not removable by clinical debridement; those with evidence of a sinus or deep track; those in whom the hallux had been amputated on the affected side (preventing the measurement of toe pressure); those with an ankle‐brachial pressure index of less than 0.7 or toe systolic pressure less than 30 mmHg; ulceration judged to be caused primarily by disease other than diabetes; patients with any other serious disease likely to compromise the outcome of the trial; patients with critical renal disease (creatinine greater than 300 mmol/L); those receiving immunosuppressants, systemic corticosteroid therapy (other than by inhalation), or any other preparation that, in the opinion of the supervising clinician, could have interfered with wound healing; those living at such a distance (generally further than 10 miles) from the clinic as would have made frequent assessment visits inappropriately expensive or impractical, or both; those who withheld consent. Ulcer characteristics at baseline (size of ulcer, number of ulcers, duration of ulceration where reported): Not reported Infection status at baseline: Not clear
Interventions	Group 1: (n = 108) Non‐adherent dressing, viscose filament gauze (Johnson & Johnson) Group 2: (n = 103) Hydrocolloid (Hydrofiber) dressing (Aquacel, ConvaTec) Group 3: (n = 106) Iodine‐containing dressing (Inadine, Systagenix) Additional comments: Dressings were changed daily, on alternate days or 3 times a week according to need or availability of professional staff, or both. Participants were advised to have a bath or shower as often as they wished, provided the ulcer could be redressed afterwards, and provided the ulcerated foot was not immersed in water for more than 5 minutes.
Outcomes	Primary review outcomes: Proportion of ulcers healed Secondary review outcomes: Health‐related quality of life (Cardiff Wound Impact Schedule and SF‐36); amputations (minor and major); adverse events (serious and non‐serious)
Notes	Randomisation was stratified by both centre and size, using a block size of 9. Randomisation was stratified across the whole population by ulcer area into 3 groups: 25 to 100 mm², 101 to 250 mm², and 251 to 2500 mm².
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomisation lists were created using SPSS (SPSS Inc., Version 14), using blinded dressing codes." Comment: Adequate
Allocation concealment (selection bias)	Low risk	Quote: "The lists were held at Cardiff University and each recruiting centre telephoned a designated number during working hours. They were required to identify the centre and size of wound only." Comment: Adequate
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: The study was not blinded to personnel and participants.
Blinding of outcome assessment (detection bias) Wound healing	Low risk	Quote: "Dressings were removed prior to examination by assessors who were not involved in the conduct of the trial and who were blind to the randomisation group."
Blinding of outcome assessment (detection bias) Infection/resolution of infection	Unclear risk	Not clear if infection assessment was blinded
Blinding of outcome assessment (detection bias) Secondary outcomes	Unclear risk	Not clear if adverse event data collection was blinded
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Quote: "Intention to treat analysis was carried out using the last value carried forward method, with strict adherence to the protocol such that only those who attended for a healing verification visit and reported as still healed at 28 days have been coded as ‘healed’ for the outcome classification." Comment: ITT analysis was done, but imputing missing data attributable to withdrawal of trial participants due to adverse events and protocol violations.
Selective reporting (reporting bias)	Low risk	Comment: Protocol not obtained, all outcomes stated in methods reported.
Other bias	Low risk	Comment: None noted.