Evaluation of Efficacy and Safety of an Innovative Multi-component Compression System versus a Four-layer Compression System in the Treatment of Venous Leg Ulcers: Results of a Multicentre Randomized Controlled Trial (Odyssey RCT)

Objective: To evaluate the efficacy, tolerance and acceptability of an innovative two-layer multi-component bandage system (MCB, UrgoK2TM) versus an established four-layer bandage system (4LB, ProforeTM) in the local management of venous leg ulcers (VLUs). 

Method: A non-inferiority European randomised controlled trial conducted in 37 centres, on patients presenting with VLUs. Participants were adult, non-immunosuppressed patients presenting with non-infected, non-malignant leg ulcers, predominantly of venous origin (ABPI_> 0.8), with a surface area of 2–50cm2 and duration 1–24 months. Patients were followed-up every 2 weeks for 12 weeks, or until full closure. The primary endpoint was percentage of leg ulcers healed after 12 weeks, with secondary endpoints of relative wound area reduction (RWAR), absolute wound area reduction (AWAR) and the percentage of wounds with RWAR_≥ 40%. 

Results: 187 patients were randomised to either the MCB group (n=94) or 4LB group (n=93). At baseline, both groups were comparable, when considering wound and patient characteristics. By week 12, 44.1% of VLUs in the MCB group had healed versus 38.7% in the 4LB group. Complete wound closure was obtained in 48% and 38% of the MCB and 4LB groups, respectively. The AWAR was 6.6cm2 in MCB group and 4.9cm2 in 4LB group. The percentage of wounds with a RWAR_≥ 40% was 47% and 44% for the MCB and 4LB systems, respectively. Pain between dressing changes was reported in 27% and 40% and the incidence of adverse events was 17% and 25% in the MCB versus 4LB group. The MCB was considered to be significantly easier to apply than the 4LB (p=0.038).

Conclusion: The UrgoK2TM system has similar efficacy than the ProforeTM system in the management of VLUs. The ease of application of UrgoK2TM combined with good local tolerance will help promote patient concordance and aid clinicians when treating VLU