Martinez‐De Jesus 2007.

Methods	RCT Setting: Outpatient clinic Country: Mexico Duration of follow‐up: 20 weeks Duration of treatment: Minimum of 10 days Funding source: Not reported Unit of analysis: Participant
Participants	45 participants Inclusion criteria: Type 2 diabetes; older than 18 years of age; infected, deep wounds at or distal to the malleoli; presence of malodour, active periwound cellulites; loss of protective sensation; and at least 1 Dopplerable pedal pulse. Exclusion criteria: Severe arterial disease; ankle‐brachial index below 0.5; a diagnosis of osteomyelitis; total gangrene of the study foot or forefoot; severe cardiovascular or renal failure; and severe neurological problems. Ulcer characteristics at baseline (size of ulcer, number of ulcers, duration of ulceration where reported): Group 1: Ulcer duration (weeks) 15.1 (SD 16.3) Group 2: Ulcer duration (weeks) 13.7 (SD 24.0) Infection status at baseline: Infected ulcers
Interventions	Group 1: (n = 16) Povidone iodine and saline. Povidone iodine was used after debridement. When the infection resolved and formation of granulation tissue was observed, the participant was switched to a surgical soap (Dermo Clean) with saline rinse to minimise the cytotoxic effects of povidone iodine. If clinical signs of infection returned, the use of povidone iodine was resumed. Group 2: (n = 21) Neutral pH super‐oxidised aqueous solution. Participants received an initial 15‐ to 20‐minute immersion of the affected foot. Following appropriate debridement, the affected foot soak was repeated either weekly or biweekly. Additional comments: All participants were treated using an outpatient ambulatory model, which included appropriate surgical debridement, administration of aggressive parenteral/intramuscular broad‐spectrum antibiotic therapy, appropriate off‐loading, and strict glycaemic control. Systemic antibiotics were given for a minimum of 10 days to all participants in both groups. Antibiotics were used for more that 10 days if clinical signs of infection continued to be present. All participants received pentoxyphylline at a dose of 1200 mg/day as a haemorheologic. All participants in both groups were instructed to reduce weight bearing on the affected foot by using a wheelchair or crutches and by resting as much as possible.
Outcomes	Primary review outcomes: Resolution of infection Secondary review outcomes: None
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote: "patient randomised using randomly alternate assignment" Comment: It was not clear whether process was random ‐ could also describe alternation.
Allocation concealment (selection bias)	High risk	Quote: "patient randomised using randomly alternate assignment" Comment: The description is not entirely clear, but allocation could have been foreseeable.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "Patients were blinded about [sic] the differences in treatment." Comment: Adequate blinding for participants but not personnel
Blinding of outcome assessment (detection bias) Wound healing	Unclear risk	Not relevant
Blinding of outcome assessment (detection bias) Infection/resolution of infection	Unclear risk	Comment: No information provided.
Blinding of outcome assessment (detection bias) Secondary outcomes	Unclear risk	Not relevant
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: Outcomes reported for all participants.
Selective reporting (reporting bias)	Low risk	Comment: All outcomes reported as outlined in methods. Protocol not obtained.
Other bias	Low risk	Comment: None noted.