medwireNews: A wound dressing that generates nitric oxide (NO) improves the healing of diabetic foot ulcers, relative to standard care, show the findings of a randomized trial.
The trial involved 135 patients with 148 ulcers. After 12 weeks of treatment, the median percentage ulcer area reduction from baseline (PAR) was 88.6% for ulcers randomly assigned to receive the NO-releasing EDX110 (Edixomed, London, UK) dressing, compared with 46.9% for ulcers that received standard care, which was a significant difference.
“Thus, there may be a significant clinical benefit gained by using EDX110 in a therapy area where recent overviews concluded that currently there is no robust evidence that any advanced dressing type is more effective than basic wound contact dressings,” the researchers comment in Wound Repair and Regeneration.
EDX110 is a two-layer system that is designed to generate NO when placed on a wound, in addition to providing a moist wound environment, absorbing exudate, and triggering autolytic debridement. The investigators were instructed to change the dressing every 48 hours. Standard care, in this trial, was the investigator’s choice of best dressing for the ulcer at that time, changed as recommended. This could be altered as needed and could include antimicrobial dressings, so that ulcers in the control group received the best possible care according to current practice.
The significant positive effect of the EDX110 dressing was seen from 4 weeks of treatment, at which point the median PAR was 53.7%, compared with 34.4% for control treatment. All values were higher in the per protocol population, with the significant advantage for EDX110 maintained.
PAR was assessed via a system for imaging and measuring wounds, meaning this could be done remotely by a clinician blinded to patients’ treatment allocation.
Michael Edmonds (King’s College Hospital, London, UK) and study co-authors note that complete healing is a more commonly used endpoint than PAR, but say they opted for PAR as a more objective measure, which “accounts for ulcers that are improving, static or, importantly, increasing in size, as well as those that heal.”
The study participants were aged an average of 59 years, and more than 80% were men. The researchers stress that they recruited a real-world study population; 30% of the EDX110 group and 34% of the control group had infected ulcers.
In the intention-to-treat population, EDX110 significantly improved the median PAR for ulcers of less than 6 months’ duration, at 97.0% versus 55.0% for control treatment, but offered no additional benefit for those of longer duration, at a respective 47% and 46%.
EDX110 offered the greatest healing boost to larger ulcers, of at least 1 cm2, with a PAR of 82.0% versus 29.2% for standard treatment, whereas both dressings were equally effective for smaller ulcers, at a corresponding 100% and 92.1%.
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