Skip to main content
. 2013 Jun 6;2013(6):CD009111. doi: 10.1002/14651858.CD009111.pub3

Baker 1993.

Methods Single centre, two‐arm RCT comparing a foam dressing (Allevyn, Smith & Nephew) with a calcium alginate dressing (Sorbsan, Aspen Medical) undertaken in the UK.
 Duration of follow‐up: Until the wound healed or for a maximum period of 12 weeks.
Participants 20 participants
 Inclusion criteria: Patients above 18 years of age with clean diabetic foot ulcers that were neuropathic in origin located on weight bearing areas of the foot. Patients who were able to give informed consent and willingly compliant to study protocol. Patients geographically able to comply with the study's demands.
 Exclusion criteria: Patients with necrotic, sloughy ulcers or peripheral vascular disease, presence of infection in ulcerative foot, patients with history of poor compliance, patients unable to attend regularly, unable to follow simple instructions and those who could not comprehend to the nature of the trial.
Interventions Group A (n = 10): Foam dressing (Allevyn, Smith & Nephew). No secondary dressing was applied .
 Group B (n = 10): Calcium alginate dressing (Sorbsan, Aspen Medical). A secondary low adherent absorbant dressing was used.
 In both groups, dressings were cut to the required size but they did not overlap the wound margins by more than 3 cm or less than 0.5 cm. The dressings were secured by standard podiatric methods; e.g. padding and or strapping. Frequency of dressing changes depended on the quantity of exudate produced by the ulcers. If upon removal either dressing should appear to be stuck, they were to be irrigated as necessary with sterile saline.
 Co‐intervention: Ulcers were cleansed with warm sterile saline only and debridement was undertaken where required.
Outcomes Primary outcome: Ulcer healing (number of ulcers healed at 12 weeks; median healing times). 
 Secondary outcome: Not reported.
Notes Trial data: Analysis 4.1
Funding source not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Each subject will be randomly allocated to one of the two treatment groups either to the Allevyn or the Sorbsan group. This will be determined by the randomisation code which is computer generated." 
 Comment: Method of generation of random schedule 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: One withdrawal (1/20 = 5%). Viewed as limited attrition.
Selective reporting (reporting bias) Low risk Comment: Based on paper only, protocol not obtained.
Other bias Unclear risk Comment: Funding source not reported.