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. 2013 Jun 6;2013(6):CD009111. doi: 10.1002/14651858.CD009111.pub3

Mazzone 1993.

Methods Two‐arm RCT (not clear if single or multi‐centred) comparing a foam dressing (PolyMem, Ferris) with wet‐to‐dry saline gauze dressing undertaken in the USA.     
 Duration of follow‐up: 8 weeks.                                      
Participants 19 participants
 Inclusion criteria: Diabetic foot ulcer. 
 Exclusion criteria: Not reported.
Interventions Group A (n = 11): Foam membrane dressing (PolyMem, Ferris). No other details.
 Group B (n = 8): Wet‐to‐dry saline gauze dressings. No other details.
 Co‐interventions: None reported.
Outcomes Primary outcome: Ulcer healing (number of ulcers healed; % reduction in wound size).
 Secondary outcomes: Not reported.
Notes Trial data: Analysis 4.1
Conference abstract.
 Funding source: Ferris manufacturing corporation (Burr Ridge,IL).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote:"..were randomly assigned…"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 is not reported.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: No mention of blinding in study report.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: No mention of blinding in study report.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: Not clear (conference abstract).
Selective reporting (reporting bias) Unclear risk Comment: Based on conference abstract, protocol not obtained.
Other bias Unclear risk Comment: Funded by commercial organisation.