An examination of PROGUIDE® in compression therapy (EXPECT): a multi-centre randomised non-inferiority trial of two compression systems in the treatment of venous leg ulcers

Background: Compression therapy is the gold standard treatment for venous leg ulcers. The aim was to determine whether the compression bandage PROGUIDE was non-inferior to an established bandaging system, PROFORE, in the treatment of ulceration. Design: Multi-centre, prospective, randomised, stratified non-inferiority trial. Methods: Patients were randomised to receive treatment with either the PROFORE or PROGUIDE bandage system. The primary outcome was the proportion of patients attaining full closure of limb ulceration by 24 weeks. A non-inferiority margin of the lower limit of the 95% CI being greater than -15% was specified. Secondary outcomes relating to bandage performance and patient endpoints were also measured. Results: Of 303 patients with venous leg ulcers, 153 were randomised to PROGUIDE and 150 to PROFORE. At 24 weeks, full closure occurred in 92 (60.1%), the ulcer remained open in 24 (15.7%) and 37 (24.2%) were discontinued. With PROFORE full ulcer closure occurred in 102 (68.0%), 27 (18.0%) had open ulcers and 21 (14%) were discontinued. In the full analysis (intention to treat) population, this corresponded to a difference in ulcer closure of –7.9% (95% CI: –19.1 to 3.4%), P=0.17. 3 Results for secondary outcomes were in favour of PROFORE for comfort (odds of an ‘uncomfortable’ or ‘very uncomfortable’ bandage being reported (p<0.001) but showed no significant difference between the two bandage systems in terms of other outcomes. Conclusions: The results did not meet the non-inferiority criterion of the lower limit of the 95% CI being greater than -15%, in either the full analysis or the per protocol population. This study has not demonstrated the non-inferiority of PROGUIDE compared to PROFORE.