The EVRA Trial: New Hope for People with Venous Leg Ulcers?

Abstract

Although contemporary epidemiological data are lacking, it is widely cited that 1e2% of people over the age of 65 years will suffer leg ulceration. Given ample evidence to show that chronic wounds are more difficult to heal, and that treating leg ulcers (especially ineffectively) consumes considerable resources, one would have thought that putting leg ulcer referral pathways in place, to ensure that an accurate diagnosis is reached as soon as possible, would be a priority for clinicians, purchasers, and policymakers. However, this approach has not been widely adopted, leading to clinically and cost-ineffective care for many patients. Surprisingly, existing guidelines, including those published by the European Society for Vascular Surgery (ESVS) in 2015, lack specific guidance regarding referral from community to specialist care. By contrast, UK National Institute for Health and Care Excellence (NICE) clinical guideline (CG) 168, published in July 2013, recommends that patients with a leg ulcer (defined as a “break in the skin below the knee that has not healed within 2 weeks”) should be referred to a “specialist vascular service” and undergo “duplex ultrasound to confirm the diagnosis of varicose veins and the extent of truncal reflux”. Unfortunately, there is little evidence to show that these UK guidelines have resulted in a change in practice, with most UK National Health Service ulcer patients still waiting months to be referred, if, indeed, they are referred at all. While barriers to early referral, assessment, diagnosis, and treatment of leg ulcers probably vary between different healthcare systems, the following seem likely candidates: (i) to avoid additional short-term expenditure, purchasers of health care will find every excuse not to refer patients to secondary care (even when there is good evidence that this is likely to reduce expenditure in the longer term); (ii) lack of education and empowerment means that patients are largely unaware of, and unable to demand, evidence based care; (iii) suboptimal training, education, and awareness among community practitioners; (iv) lack of “level 1” evidence from randomised controlled trials showing that early intervention for venous ulceration is clinically and costeffective. With regard to the last point, although the ESCHAR trial, published almost 15 years ago, demonstrated conventional surgery to ablate superficial venous reflux reduced ulcer recurrence, it did not improve healing. Furthermore, many