Lalau 2002.
| Methods | A multi‐centred, 2‐armed RCT comparing a calcium alginate dressing (Algosteril, Smith & Nephew) with Vaseline gauze (Vaselitulle, Solvay Pharma), undertaken in France. Duration of follow‐up: 6 weeks. The study report stated, however, that, due to premature cessation of treatment in 13 out of 77 patients, it was decided to shorten the period of the efficacy analysis to 4 weeks. The authors said that "this reduction was not accompanied by a revision of the criterion of efficacy and all patients remained included in the 6‐week tolerance analysis study" (it was not clear to what the mention of "tolerance analysis" refers). | |
| Participants | 77 participants. Inclusion criteria: patients < 75 years old, with Type 1 or 2 diabetes and a foot lesion in phase of cleansing (granulation tissue surface of less than 50% of wound area) with surface area between 1 cm2 and 50 cm2. Exclusion criteria: HBA1c level of more than 10%; presence of clinical infection with redness, swelling, warmth and peri‐wound erythema; osteomyelitis on plain radiography or probing of bone; a tunnelled wound; any severe hypovascularisation. | |
| Interventions | Group A (n = 39): calcium‐alginate dressing (Algosteril, Smith & Nephew). Group B (n = 38): Vaseline gauze (Vaselitulle, Solvay Pharma). In both groups dressings were applied directly to the wound for up to 6 weeks. Dressing were changed every day until debridement, and then every 2 to 3 days. No other treatment was permitted except the use of saline solution. In both groups sterile gauze was applied as secondary dressing. Co‐interventions: conservative management was carried out using appropriate pressure‐relieving methods. | |
| Outcomes | Primary outcome: ulcer healing (% of ulcers with granulated tissue over 75% of wound area and 40% decrease in wound surface area; mean change in wound area). Secondary outcomes: adverse events (pain on dressing change and other events); costs (total number of dressing changes). Health‐related quality of life, amputations and ulcer recurrence not reported. | |
| Notes | Trial data: Analysis 4.1 Funding source: laboratories Brothier (Parris‐Nanterre, France). |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote:"Patients were randomly assigned to receive treatment with either calcium alginate or Vaseline gauze". 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:"This was an opened controlled trial for 6 weeks with blinded evaluation." Comment: the trial was stated as being open‐label. No other details provided in the text. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote:"An independent investigator, blind to allocated treatment, was assigned to analyse wound area surfaces." Comment: outcome assessors were blinded. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: In total 13 patients did not complete the full 6 weeks of the study. It was unclear how these were analysed — it seems that the author conducted the main analysis at four weeks to 'gain' more data. |
| Selective reporting (reporting bias) | Low risk | Comment: based on study report, protocol not obtained. |
| Other bias | Unclear risk | Comment: there was some baseline imbalance in wound duration with 4.9 ± 7.8 months in alginate group vs 9.1 ± 13.1 months in Vaseline gauze group. Funded by a commercial company. |
Abbreviations
± = plus or minus > = greater than ≥ = greater than or equal to < = less than ≤ = less than or equal to HBA1c = glycate haemoglobin ITT = intention‐to‐treat analysis n = number in sample/group RCT = randomised controlled trial TcPO2 = transcutaneous oxygen pressure