WoundCHEK - helping fight the burden of chronic wounds

Chronic wounds are skin lesions that fail to heal normally. They include diabetic foot and leg ulcers, pressure sores, traumatic and non-healing surgical wounds, and are associated with poor quality of life and increased mortality. Wound care costs the NHS over £8 billion per annum, which is higher than obesity. Diabetic foot ulcers are a leading cause of lower limb amputation, which has poorer, five-year mortality than many cancers, and around half of venous leg ulcers don’t heal within twelve months. The problem is increasing dramatically mainly due to an ageing population and higher prevalence of chronic diseases such as diabetes.

There has been little innovation in the wound care field for decades and very few diagnostic technologies exist to assist clinicians in treatment choice. Treatment tends to be determined by clinical signs, symptoms and a holistic view of the patient, which are subjective, relying heavily on clinician’s experience and commonly result in a sub-optimal trial and error approach. New advanced therapies such as protease modulating dressings, skin substitutes and topical negative pressure therapy tend to be expensive and usage is often delayed until the wound has been shown to be unresponsive to conservative care, and by this time the chances for successful healing have diminished significantly.

Mediocre performance and lack of good quality trials to prove efficacy of these advanced therapies has been a barrier to gaining widespread reimbursement or adoption on formularies. Woundchek Laboratories (WCL) spotted an unmet need for simple diagnostics that could be conducted during a treatment visit/dressing change which could identify why a wound was not healing and assist the clinician in determining the appropriate therapy, rather than continuing with trial and error. The premise was that targeted use would increase therapy efficacy, cost-effectiveness, and make inclusion on formularies and re-imbursement more likely, facilitating a new paradigm in wound management.

Based in Gargrave, North Yorkshire and Massachusetts, USA, WCL was spun out of the Systagenix Wound Management business in 2014 to continue to exploit the wound diagnostic research & development initiated by Johnson & Johnson in the 1990s. WCL has CE-marked and commercialised wound fluid qualitative lateral flow tests, WOUNDCHEKTM Protease Status and  WOUNDCHEKTM Bacterial Status, which detect the presence of elevated neutrophil derived proteases (e.g. matrix metalloproteases or MMPs) and bacterial proteases (virulence factors secreted by pathogens) respectively. Elevated MMPs are indicative of chronic inflammation and presence of bacterial protease activity is an early indication of infection, with both conditions being significant contributors to non-healing of wounds.

Over the past eight years, WCL have invested heavily in gaining regulatory approval and pre- and post-marketing clinical data to highlight the benefit of testing to improve outcomes and reduce cost of wound management. A randomised trial conducted in primary care in the Pennine region identified that using WOUNDCHEKTM Bacterial Status to direct use of antiseptic dressings reduced annualised nursing time by 29%, which would realise predicted savings of at least £750 per wound. In addition, antibiotic usage trended 45% lower, contributing to antimicrobial stewardship. WOUNDCHEKTM Bacterial Status has also been shown to be predictive of amputation risk, with positive wounds over five times more likely to end with amputation. Another study involving both tests at four wound clinics in Northern Italy found wound healing or improvement was more than ten-fold higher when treatment decisions were assisted by the diagnostic tests. Whilst use of artificial skin substitutes is becoming increasingly common, failure of the graft is extremely costly. A study testing graft patients with WOUNDCHEKTM Protease Status demonstrated that wounds with elevated protease failed over two thirds of the time, whereas low protease wounds enjoyed 100% graft success.

In late 2019, WOUNDCHEKTM Bacterial Status realised the key milestone of de novo approval from the FDA, a tremendous achievement considering very few new diagnostic tests have been cleared since inception of the de novo process in the late 1990s. WCL has now begun efforts to promote adoption of the technology in the US. Integrating new technologies into standard care and changing the practice of medicine is always a huge challenge and takes time. The pandemic over the last two years has added additional hurdles. However, WCL are very confident in the value proposition of their diagnostic tests and know they can make a difference to wound care outcomes and patient’s quality of life. One positive for WCL from the last two years is that there is no longer a need to explain to customers what a lateral flow test is – that term is now well-established in the vernacular!