Jacobs 2008.
| Methods | RCT Setting: Office of study author (no further details) Country: Not reported Duration of follow‐up: 6 weeks Duration of treatment: 6 weeks Funding source: Not reported Unit of analysis: Participant |
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| Participants | 40 participants Inclusion criteria: Wagner grade I or II ulcerations of the foot. Study authors note that all patients included in the study presented with ulcers that were 3 centimetres in diameter or less on the plantar aspect of the foot (unclear if inclusion criteria or not). Currently under care for diabetes. Exclusion criteria: Glycated haemoglobin greater than 10%. Ulcer characteristics at baseline (size of ulcer, number of ulcers, duration of ulceration where reported): Not clearly reported Infection status at baseline: Not reported |
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| Interventions | Group 1: (n = 20) Silver sulphadiazine cream (no further details). Group 2: (n = 20) Formulation of benzoic acid, 6%; salicylic acid, 3%; and extract of oak bark (Quercus rubra), 3% (Bensal HP with QRB7), with silver sulfadiazine cream. Additional comments: All participants were treated by off‐loading of weight bearing and shoe pressure from the area of ulceration. Debridement with a scalpel was performed as determined for each participant. |
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| Outcomes | Primary review outcomes: Proportion of ulcers healed (referred to as "resolved" by study authors) Secondary review outcomes: None reported |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "A research coordinator randomly assigned patients to receive ..." Comment: No further details provided. |
| Allocation concealment (selection bias) | Unclear risk | Comment: As above |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "This was a blinded study" Comment: No further details provided. |
| Blinding of outcome assessment (detection bias) Wound healing | Unclear risk | Comment: As above |
| Blinding of outcome assessment (detection bias) Infection/resolution of infection | Unclear risk | Not relevant |
| Blinding of outcome assessment (detection bias) Secondary outcomes | Unclear risk | Not relevant |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: It seems from report that all participants were followed up, as results table contains data for all 40 randomised participants. |
| Selective reporting (reporting bias) | Low risk | Comment: Protocol not obtained, all outcomes stated in methods reported. |
| Other bias | Low risk | Comment: None noted. |