| Methods |
Design: three group parallel trial
Purpose: study the effect of 685 nm laser and placebo on venous leg ulcers |
| Participants |
Patients: out‐patients with venous leg ulcers
Baseline comparability: yes |
| Interventions |
Placebo: polychromatic red light
Untreated: no light
Experimental: 685 nm laser light (red)
(Co‐intervention: standard venous leg ulcers treatments) |
| Outcomes |
Area of leg ulcers (photographs) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'... weder vom Arzt noch vom Patienten unterschieden werden kann' |
| Blinding?
Outcome assessor |
Low risk |
'Erst nach Ende der Nachbeobachtungensphase (Tag 90) wurden die verwendeten als A und B be zeichneten Geräte decodiert (entblindet), um die Ergebnisse nicht zu beeinflussen' |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
| Trial size > 49? |
High risk |
N = 26 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
