Faglia 1996a.
| Methods | Randomised controlled trial. No blinding reported | |
| Participants | 70 people with diabetes and a foot lesion Wagner grade 2 to 4 Group 1: 33 randomised Group 2: 37 randomised |
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| Interventions | Group 1: standard care consisting of a specialised multidisciplinary wound management programme Group 2: HBOT at 2.2 to 2.5 ATA for 90 minutes on an average of 39 occasions over about 6 weeks |
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| Outcomes | Major amputation Transcutaneous oxygen Minor amputations Vascular procedures |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Patients were allocated to treatment arms by consulting a table of random numbers at the hospital |
| Allocation concealment (selection bias) | Unclear risk | No statement on allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No statement on blinding of patients. Since the control group received only conventional treatment and no sham therapy, the patients were unblinded. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No statement on blinding of outcome assessors |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | One HBOT patient refused treatment and one HBOT patient died |
| Incomplete outcome data addressed (use of intention‐to‐treat (ITT) analysis) | High risk | Quote: "Both these subjects were excluded from the analysis of the results." |
| Selective reporting (reporting bias) | Unclear risk | No protocol available, but all outcomes in methods section are reported in results |