Eriksson 1991.
Methods | Randomised trial comparing US plus standard care with sham US plus standard care in Sweden. | |
Participants | People with venous leg ulcers referred from departments of internal medicine and surgery, and primary care providers Exclusion criteria: allergy to the standard treatment, or evidence of peripheral arterial disease, rheumatoid arthritis, diabetic ulcers, or traumatic venous ulcers US group: n = 19; Sham US group: n = 19 |
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Interventions | US group: US 1 W/cm2 at 1 MHz, for 10 minutes twice a week for 8 weeks, plus standard treatment Sham US group: standard treatment plus sham US as above, but with no output. Standard care comprised cleansing with saline; paste bandage, support bandage plus exercise advice. | |
Outcomes | Number of ulcers known to be completely healed at 8 weeks (of those randomised) Percentage ulcer area healed at 8 weeks (SD) Withdrawals with reasons, and by group | |
Notes | Duration of follow‐up: 8 weeks | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "patients were randomly assigned to either a control group ... or a treatment group" |
Allocation concealment (selection bias) | Unclear risk | See above. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants: this was a placebo (sham) US controlled trial, therefore, it was implied that the participants did not know their allocation. Personnel: unclear (they may have been responsible for setting the ultrasound machine to zero). |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessors: unclear whether those responsible for taking ulcer tracings were blinded. Those responsible for analysing the tracings were blinded, quote: "At the end of the 8 week study all tracings were analysed using a computer graphics program to calculate the areas of each ulcer...The tracings were identified by code numbers to exclude observer bias." |
Incomplete outcome data (attrition bias) Ulcer healing | Unclear risk | 38 people randomised; 13 withdrew. Not clear how these were handled. Quote: "The cumulative percentage of healed ulcers in the two groups was compared by the use of life table methods" (censoring not mentioned), and. In the Results section: "If analysed by intention to treat there were similar non‐significant findings between the groups". |
Selective reporting (reporting bias) | Unclear risk | No details provided. |
Other bias | Unclear risk | No details provided. |