Donaghue 1998.

Methods	2‐armed RCT (not clear if single‐ or multi‐centred) comparing a collagen‐alginate dressing (Fibracol, Johnson & Johnson Medical) with saline‐moistened gauze undertaken in the USA. Duration of follow‐up: until the target ulcer healed, or for a maximum of 8 weeks.
Participants	75 participants. Inclusion criteria: diabetic patients ≥ 21 years old with foot ulceration of at least 1 cm2 in size after initial debridement; adequate nutritional intake (indicated by a serum albumin of > 2.5 g/dl) and adequate blood flow to the lower extremities (indicated by palpable pulse and/or normal noninvasive tests). Exclusion criteria: patients with severe renal or liver impairment (indicated by creatinine levels and liver function tests 2 or more times higher than normal); presence of any serious medical disorders that could interfere with wound healing; evidence of osteomyelitis (diagnosed by the existence of a deep ulcer probing to bone, or by radiographic findings); clinical signs of infection; history of drug or alcohol abuse.
Interventions	Group A (n = 50): collagen‐alginate dressing (Fibracol, Johnson & Johnson Medical). Group B (n = 25): saline‐moistened gauze. In both group, patients or caregivers also were given explicit instructions for dressing changes and were told to change the wound dressing as often as required. Co‐intervention: weight‐bearing limitation in all participants was achieved by employing the standard procedure of applying a self‐adhesive felted foam dressing to the foot with a window at the site of the ulcer and the use of healing sandals.
Outcomes	Primary outcome: ulcer healing (number of ulcers healed; mean time to healing; % ulcers with 75% or greater reduction in wound area; mean time to 75% healing in weeks). Secondary outcomes: adverse events. Health‐related quality of life; amputations; costs and ulcer recurrence not reported.
Notes	Trial data: Analysis 4.1 Adverse events not reported for each arm. Also important to note that whilst an ITT analysis was undertaken, including the 14 people that were withdrawn, the treatment of this missing data was not discussed. We assumed that withdrawals were treated as not having healed. Funding Source: Johnson & Johnson Medical Arlington, TX.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Patients were assigned randomly in a 2:1 ratio open‐label design" Comment: method of generation of random schedule not reported.
Allocation concealment (selection bias)	Unclear risk	Comment: the process of randomising participants, including who did this, was not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Patients were assigned randomly in a 2:1 ratio open‐label design" Comment: This was labelled an open trial.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "Patients were assigned randomly in a 2:1 ratio open‐label design" Comment: This was labelled an open trial not clear if blinded evaluation was conducted.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "sixty‐one of the original 75 (81%) enrolled patients completed the study." Quote: "All 75 patients enrolled were included in this intention to treat analysis" Comment: it was unclear what assumptions were made about the missing data.
Selective reporting (reporting bias)	Unclear risk	Comment: based on paper only, protocol not obtained.
Other bias	Unclear risk	Comment: funded by commercial organisation.