🟠 Moderate Evidence
A large randomised controlled trial has found that two-layer compression bandages are clinically equivalent to the standard four-layer bandage treatment for healing venous leg ulcers, according to research published in PLOS Medicine. The VENous Ulcer Study 6 (VenUS 6), conducted across 33 United Kingdom sites between February 2021 and August 2024, randomised 637 adults with venous leg ulcers to compare three compression strategies: compression wraps, two-layer bandages, and evidence-based compression (four-layer bandages or two-layer hosiery).
Key takeaways
- Two-layer compression bandages achieved non-inferior healing outcomes compared to four-layer bandages and two-layer hosiery in a 637-person randomised trial
- Compression wraps showed inferiority to both standard therapies, with slower ulcer healing times
- Findings may simplify treatment protocols and reduce cost burden for primary care services managing venous ulcers
Study at a Glance
| Source | PLOS Medicine |
| Study type | Pragmatic three-arm randomised controlled trial |
| Sample size | N = 637 participants |
| Population | Adults with venous leg ulcers appropriate for compression therapy |
| Country | United Kingdom (33 primary, community, and hospital sites) |
VenUS 6 Trial: Participants by Treatment Arm
Randomised allocation of adults with venous leg ulcers, February 2021–August 2024
Source: VenUS 6 Trial, PLOS Medicine, 2024 | Georgian Medical Journal News
Two-Layer Bandages Show Non-Inferiority Against Standard Care
The trial’s primary analysis examined time to ulcer healing using Cox proportional hazards regression, adjusting for baseline ulcer area and duration, participant age, mobility status, and recruitment site. The research team, led by investigators at the University of Manchester and other UK National Institute for Health and Care Research–funded centres, compared two-layer bandage therapy against evidence-based compression (EBC)—the current recommended first-line treatment—using a non-inferiority framework.
The two-layer bandage group demonstrated clinical equivalence to EBC across the study population, according to the trial’s primary analysis. This finding challenges assumptions about the necessity of more complex, four-layer compression systems in routine practice and suggests a simplified alternative may be equally effective for healing venous leg ulcers.
Compression Wraps Underperform Compared to Bandage-Based Therapies
Compression wraps, increasingly marketed as a patient-friendly alternative, showed inferiority to both two-layer bandages and evidence-based compression in superiority analyses. The trial found that participants assigned to compression wraps experienced prolonged healing times relative to bandage-based treatments, suggesting limited clinical utility for this modality in standard venous ulcer management.
The pragmatic design—which allowed clinical staff discretion within the treatment protocol and did not blind participants or staff—reflects real-world care conditions. This approach strengthens generalisability to routine primary and community care settings, where most venous ulcers are managed in the United Kingdom and across Europe.
Implications for Cost and Service Delivery
Two-layer bandage systems are typically less expensive and faster to apply than four-layer compression bandages, with reduced training requirements for community nurses. If non-inferiority is confirmed in clinical practice rollout, the findings could reduce financial burden on primary care trusts while maintaining healing efficacy—a significant advantage in resource-constrained healthcare systems.
The trial was registered prospectively (ISRCTN67321719) and conducted across 33 sites in England, Scotland, and Wales, enhancing the generalisability of findings to diverse UK healthcare settings. Recruitment occurred between February 2021 and August 2024, a period that included recovery from the COVID-19 pandemic, potentially reflecting more representative care patterns than earlier pandemic-era trials.
Two-layer compression bandages achieved non-inferiority compared to evidence-based compression (four-layer bandages and two-layer hosiery) for time to venous leg ulcer healing in a pragmatic 637-person randomised trial across 33 UK sites.
— VenUS 6 Investigators, University of Manchester and UK National Institute for Health and Care Research, PLOS Medicine (2024)
What this means
Frequently asked questions
What is evidence-based compression (EBC) for venous ulcers?
Evidence-based compression refers to the current standard-of-care compression therapies recommended by clinical guidelines: either four-layer compression bandages or two-layer compression hosiery. These systems deliver sustained, graduated compression to improve blood flow in the lower leg and promote ulcer healing.
Why did compression wraps perform poorly compared to bandages?
Compression wraps may not provide consistent, sustained compression over time and require precise application to be effective. The trial suggests that wraps deliver insufficient or unstable compression compared to bandage systems, resulting in slower healing rates.
Can these findings be applied to non-UK healthcare systems?
The VenUS 6 trial reflects UK primary and community care settings. While findings are broadly relevant to similar healthcare systems with comparable resources and staff training, implementation should account for local capacity, cost structures, and clinical guidelines in other countries.
The VenUS 6 trial represents one of the largest contemporary evaluations of compression therapies for venous leg ulcers and provides robust evidence to support simplification of treatment algorithms in primary care. If health systems adopt two-layer bandages as first-line therapy, future research should monitor long-term outcomes, patient preference, and real-world effectiveness across diverse care settings. More broadly, these findings reinforce the importance of pragmatic trials that test interventions under realistic conditions, ensuring that evidence directly informs routine clinical practice.
Source: VENous Ulcer Study 6 (VenUS 6): Compression Therapies for Venous Leg Ulcers—A Randomised Controlled Trial, PLOS Medicine, 2024
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