Skip to main content
. 2014 Jan 10;2014(1):CD003557. doi: 10.1002/14651858.CD003557.pub5

Morias 1979.

Methods Randomised controlled trial conducted in Belgium
Participants 59 people with chronic leg ulcers, 45/59 (76%) of venous aetiology, were recruited
 Group 1: 29 people
 Group 2: 30 people
Median (range) baseline ulcer area (mm2): Group 1: 100 (4 to 3300); Group 2: 100 (3 to 4400)
 No information about baseline ulcer duration or infection status of wounds
Interventions 1. Placebo tablet identical in appearance to levamisole
 2. Levamisole dosed according to body weight ranging from 100 to 250 mg, given on 2 consecutive days every week until cure or failure or for 20 weeks
Previously used topical treatment was continued for all participants; no information about whether this included compression
Outcomes At 20 weeks
 Number of ulcers cured
 1. 22/29 (76%)
 2. 30/30 (100%)
Secondary outcomes:
 Adverse effects
 1. Group 1: 0/29 (0%)
 2. Group 2: 3/30 (10%) ‐ all were gastric complaints
Notes Group 1: evident failure (8)
 Group 2: evident failure (2)
The trial authors state that double‐blind treatment was stopped before the end of the trial in eight participants in Group 1 and two participants in Group 2 because of "evident failure" (defined as no improvement). However, other information in the trial report suggests that all 59 participants were followed up for 20 weeks
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "All patients were sequentially numbered and received a bottle bearing their individual sequence number and containing double‐blind tablets. These tablets randomly contained either 50 mg of levamisole (30 patients) or a placebo (29 patients) and were identical in appearance." It was not stated how the randomisation sequence was generated
Allocation concealment (selection bias) Low risk Reports "sequentially numbered drug containers of identical appearance"
Blinding (performance bias and detection bias) 
 Participant blinded to the intervention Low risk "these tablets randomly contained either 50mg of levamisole or a placebo and were identical in appearance"
Blinding (performance bias and detection bias) 
 Outcome assessor blinded to the intervention Unclear risk No information provided
Incomplete outcome data (attrition bias) 
 Drop out rate described Low risk Participants complete at analysis; no dropouts or withdrawals reported
Incomplete outcome data (attrition bias) 
 Drop out rate acceptable Low risk No withdrawals reported
Incomplete outcome data (attrition bias) 
 ITT analysis Low risk Participants complete, no exclusions
Baseline factors comparable Unclear risk The two groups appeared comparable for baseline ulcer area. However, no information about baseline ulcer duration was available, and it was not stated whether wounds were clinically infected