Dolibog 2008.
| Methods | Randomised controlled trial in Poland. | |
| Participants | 70 participants post venous surgery, whose venous disease was diagnosed by Duplex scan (to rule out arterial disease and locate the venous insufficiency) Exclusion criteria: diabetes, and rheumatoid arthritis US plus standard care group: n = 33; Standard care group: n = 37 |
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| Interventions | US group: US via a water bath at 0.5 W/cm2; 1 MHz frequency, US probe 10 cm2 placed 2 cm above ulcer. An ulcer of 5 cm2 or less had 5 minutes treatment with 1 minute extra of treatment for every 1 cm2 by which the ulcer exceeded an area of 5 cm2. Treatment provided daily for 6 days/week for 7 weeks. Between treatments ulcers were covered with saline‐soaked gauze, received compression and 1 g flavonoid fraction daily. US commenced 5 days after surgery. Standard care group: saline soaks, compression, 1 g flavonoid fraction daily | |
| Outcomes | Proportion of ulcers completely healed | |
| Notes | Ulcers were observed for complete healing and measured for area, volume and a range of dimensions using planimetry. Duration of follow‐up: 7 weeks | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "70 patients ... were included and allocated into two comparative groups", "A prospective, randomised, controlled clinical trial was conducted" |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned, see above. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants: not blinded, since they did not receive sham US. Personnel: unclear, but presumably not blinded since study was not sham controlled. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessors: unclear Quote: "Treatment progress was evaluated by observing the number of completely healed ulcers, and measuring the area ... by planimetry" |
| Incomplete outcome data (attrition bias) Ulcer healing | Unclear risk | Final numbers not stated; complete follow‐up implied. |
| Selective reporting (reporting bias) | Unclear risk | No details provided. |
| Other bias | Unclear risk | No details provided. |