A new wound care device, that harnesses the properties of nitric oxide, can heal diabetic foot ulcers faster and more effectively than current standard care, according to those behind the technology.
They claimed it had the potential to “revolutionise” wound care and to dramatically reduce the number of amputations, along with helping to help cut clinic hours and lessen hospital stays.
“EDX110 represents a major step forward in best practice care”
The new wound care system, called EDX110, healed diabetic foot ulcers “dramatically faster and more effectively” than current standard care dressings in a UK trial, said its Edinburgh-based developer Edixomed.
The “real world” trial assessed the safety and efficacy of EDX110, a nitric oxide (NO) generating medical device, in the treatment of diabetic foot ulcers, compared against optimal standard care.
The results, which have been published in the journal Wound Repair and Regeneration, suggested that the device reduced ulcer size by almost double the amount standard care achieved.
The new study, which involved 135 “real world patients”, was conducted in 10 UK hospitals and focused on 148 diabetic foot ulcers.
“Diabetic foot ulcers are notoriously hard to heal”
The ulcers were full thickness, with an area of 25‐2,500mm2 and either a palpable pedal pulse or ankle brachial pressure index of less than 0.5. Infected ulcers were also included.
All participants were given optimal debridement, offloading and antimicrobial treatment – the only difference being the fixed used of EDX110 as the wound dressing in around half of the group.
Results from the study showed that in 12 weeks EDX110 reduced ulcer size by almost double that of standard care – 89% versus 47% – said the researchers.
They said the device also increased the number of completely healed ulcers by more than 50% – 49% versus 30% – and nearly doubled the complete healing of infected ulcers – 45% versus 23%.
In addition, it significantly reduced hospitalisations and serious adverse events related to the ulcer, compared with standard-of-care at 12 weeks.
“This study, in a real world clinical foot ulcer population, demonstrates the ability of EDX110 to improve healing, as measured by significantly reducing the ulcer area, compared to current best clinical practice,” stated the researchers in Wound Repair and Regeneration.
“With this technology, we have a viable and innovative solution to strike back”
Edixomed describes EDX110 as a “revolutionary, disruptive, wound care system” that harnesses NO, one of the body’s natural defence mechanisms, to kill bacteria, viruses and fungi.
This includes the hardest to treat antibiotic resistant strains, such as MRSA and E. coli, said the UK biotechnology firm.
The key technology that the device uses is a sustained-release NO generating platform, which has been developed by the firm, and can be delivered as a dressing, a liquid, gel or inhaled spray.
As a result, EDX110 provides a protective and cushioning layer that uniquely absorbs fluid while providing a moist environment and generating nitric oxide, said the company.
Lead study author Professor Michael Edmonds, from King’s College Hospital, London, said: “Diabetic foot ulcers are notoriously hard to heal, and are the leading cause of diabetes-related amputations in the UK.
“The findings reported today provide an essential step forward in developing solutions for the effective management of these chronic wounds,” he said.
“Reducing infection and accelerating healing could significantly contribute to a reduction in the number of avoidable amputations,” he said. “EDX110 represents a major step forward in best practice care.”
“Edixomed has developed a completely new, important solution to the problem of chronic wound care”
Edixomed noted that EDX110 was not yet an approved product, but said it was seeking to develop applications for its core NO technology in multiple wound care indications and other areas.
Study author Professor Art Tucker, from St Bartholomew’s Hospital in London, said: “Infections resistant to all currently available antibiotics are expected to kill 10 million people a year by 2050.
“The threat is very real but with this technology, we have a viable and innovative solution to strike back with, and wound care is just the first of many potential applications” he said.
Professor Chris Wood, chief medical officer for Edixomed, said the firm was “excited” by the results that it had seen in the “clinic and lab”.
“Edixomed has developed a completely new, important solution to the problem of chronic wound care and the major issue of antimicrobial resistance,” he added.
Wound care device ‘dramatically’ improves diabetic foot ulcer healing