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. |
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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. |
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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). |
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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. |