Venous leg ulcers affect roughly one percent of adults in high-income countries and consume disproportionate nursing resources, yet the optimal compression system has remained contested. A head-to-head randomised trial comparing three widely used approaches now offers some of the most direct clinical evidence available — and the results carry real implications for community wound-care practice.
The VenUS 6 trial enrolled adults across 33 UK primary, community, and hospital sites between early 2021 and mid-2024, randomising participants 1:1:1 to compression wraps (CW), two-layer compression bandages, or evidence-based compression (EBC), the latter encompassing either four-layer bandages or two-layer hosiery. The primary endpoint was time to healing, adjudicated by blinded photograph review — an important methodological safeguard in an otherwise open-label design. The analytical framework was sophisticated: the EBC-versus-two-layer bandage comparison used a noninferiority design, while CW comparisons were tested for superiority. Cox regression models adjusted for ulcer area, duration, patient age, and mobility, with shared frailty terms accounting for site-level clustering across 33 recruitment centres.
The trial's design addresses a meaningful gap. Evidence-based compression — four-layer bandages in particular — has long been the reference standard following the original VenUS trials, but both two-layer bandages and adjustable compression wraps have gained clinical traction partly on grounds of ease of self-application and patient comfort. Whether that convenience comes at a healing cost has been unclear. By framing the two-layer bandage comparison as a noninferiority question, the investigators signal awareness that clinical adoption may hinge on equivalence rather than superiority. The open-label design is a limitation inherent to compression research, and the pragmatic, multi-site structure means real-world heterogeneity in clinician technique is baked into the results — both a strength for generalisability and a complicating factor for clean mechanistic inference. As a large Phase III RCT in a chronic-wound population with direct clinical practice implications, this trial represents a meaningful, potentially practice-shaping contribution rather than incremental evidence.