Skip to main content
. 2013 Jun 25;2013(6):CD009110. doi: 10.1002/14651858.CD009110.pub3

Jude 2007.

Methods Multi‐centred, 2‐armed RCT comparing a calcium‐alginate dressing (Algosteril, Smith & Nephew) with a fibrous‐hydrocolloid (hydrofibre) dressing with 1.2% ionic silver (Aquacel Ag, ConvaTec) undertaken in the UK, France, Germany, and Sweden. Duration of follow‐up: 8 weeks.
Participants 134 participants.
 Inclusion criteria: patients with Type 1 or Type 2 diabetes mellitus (HbA1c ≤ 12%); serum creatinine ≤ 200 mol/l; neuropathic or neuro‐Ischaemic diabetic foot ulcers classed as Wagner grade 1 or 2; all wounds > 1 cm2 in area.     
 Exclusion criteria: patients with known allergies to dressings being investigated; known or suspected malignancy near ulcer; taking systemic antibiotics > 7 days prior to enrolment; inadequate arterial perfusion defined by ankle‐to‐brachial index < 0.8, or great toe systolic blood pressure < 40 mmHg or forefoot TcPO2 < 30 mmHg (subject supine) or < 40 mmHg (participant sitting).   
Interventions Group A (n = 67): calcium‐alginate dressing (Algosteril, Smith & Nephew). Manufacturers' instructions were followed, and dressing was moistened before use on dry wounds, and changed on leakage or at evaluation or every 7 days as indicated (except for infected wounds on which the dressing was changed daily).                       
Group B (n = 67): fibrous‐hydrocolloid (hydrofibre) dressing with 1.2% ionic silver (AQUACEL® Ag, ConvaTec). Left in place and changed on leakage or at evaluation or every 7 days as indicated.  
In both groups, ulcers were cleansed using sterile saline, each dressing was covered with a sterile, non‐adherent foam dressing.
Co‐intervention: accommodative footwear for non‐plantar ulcers and off‐loading for planter ulcers delivered as required.  
Outcomes Priamry outcome: ulcer healing (number of ulcers healed; velocity of healing; mean time in days to healing; reduction in ulcer area; reduction in ulcer depth).
 Secondary outcomes: adverse events, costs (mean number of dressing changes during study).
Health‐related quality of life, amputations, and ulcer recurrence not reported.
Notes Trial data: Analysis 4.1
22 participants had clinically infected ulcers at baseline, 13 in Group A and 9 in Group B. On enrolment antibiotics were prescribed to 8 in Group A and 13 in Group B.
 Funding source: ConvaTec (Bristol Myers Squibb).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote:" Individuals were randomly assigned to receive either...(dressing details)... according to instructions in a sealed envelope and stratified according to whether or not systemic antibiotics were being administered for treatment of the study ulcer"Comment: method of generation of random schedule reported.
Allocation concealment (selection bias) Unclear risk Comment: not clear if envelopes were sequentially numbered, opaque and sealed.
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 Low risk Comment: 21 participants recorded as discontinuing treatment, however, it does not seem that these were study withdrawals. All randomised participants included in the analysis.
Selective reporting (reporting bias) Low risk Comment: based on study report, protocol not obtained.
Other bias Unclear risk Comment: funded by commercial organisation.