Franek 2006.
Methods | Randomised trial in different hospitals in Poland | |
Participants | 92 people with venous leg ulcers presenting symptoms of chronic venous insufficiency, some had varicose veins and symptoms of postthrombotic syndrome. ABPI > 0.8 Exclusion criteria: presence of diabetes or atherosclerosis Number of male: female participants: Electrostimulation group: 8:18; Laser therapy group: 4:17; US group: 4:11; Compression + pharmacological agents: 3:21 Mean (range) participant age in years: Electrostimulation group: 69.8 (48‐90); Laser therapy group: 65.2 (44‐80); US group: 63.6 (37‐82); Compression + pharmacological agents: 67 (43‐86) Mean (range) initial ulcer area in cm2: Electrostimulation group: 17.6 (2.6‐65.8); Laser therapy group: 15.8 (0.5‐59.6); US group: 15.6 (0.4‐84.7); Compression + pharmacological agents: 17.3 (1.9‐84) Mean (range) ulcer duration in months/years: Electrostimulation group: 4.5 years (2 months‐12 years); Laser therapy group: 3.5 years (2 months‐24 years); US group: 1.7 years (3 months‐8 years); Compression + pharmacological agents: 2.7 years (3 months‐11 years) |
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Interventions | All groups received compression therapy, bandages were removed for purposes of physical therapy and then put back on. Electrostimulation group: 50‐minute session once daily, for 6 consecutive days, for a total of 4 weeks total (2 weeks katodic and 2 weeks anodic stimulation), NaCl 0.9% locally (no further details provided) Laser therapy group: 65 mW laser therapy session once daily, for 5 consecutive days, the duration of each session depended on the size of ulceration area – device was set up to develop 4 J/cm2 on average power 65 mW, various pharmacological agents applied locally, for a total of 4 weeks US group: 0.5 W/cm2 once daily, duration of each session depended on the size of ulceration area: 5 minutes of therapy given for 5 cm2 ulcer, 1 additional minute of therapy given for each additional 1 cm2 of ulceration area, for a total of 4 weeks, NaCl 0.9% locally Compression (no further details provided) plus pharmacological agents: compression and local application of collistin (no further details provided), chloramphenicol, gentamycin, fibrolan, potassium permanganate, copper sulphate, according to medical indications, no phlebotropic drugs), for a total of 4 weeks |
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Outcomes | Changes in the area, length, width and volume of the tissue defect after above physical therapies | |
Notes | No withdrawals reported. Duration of follow‐up: 4 weeks | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | From translator: "... random assignment ... " Comment: no randomisation method specified. Authors did not state whether participants were randomized before or after surgery. |
Allocation concealment (selection bias) | Unclear risk | No details provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details provided. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided. |
Incomplete outcome data (attrition bias) Ulcer healing | Unclear risk | No report of withdrawals, and not clear from report whether all participants were included in the analyses. |
Selective reporting (reporting bias) | Unclear risk | No details provided. |
Other bias | Unclear risk | No details provided. |