By Will Boggs MD
NEW YORK (Reuters Health) – A new wound dressing that generates nitric oxide (EDX110) improves healing of diabetic foot ulcers, according to results from the ProNOx1 trial.
“The critical factors that delay the healing of diabetic foot ulcers are ischemia and infection,” Dr. Michael E. Edmonds from King’s College Hospital in London told Reuters Health by email. “Nitric oxide (NO) plays a crucial role in maintaining the microvascular supply and infection control in the skin, and its absence in diabetes contributes to poor ulcer healing. EDX110 generates a sustained release of nitric oxide which can treat both infection and ischemia simultaneously.”
Dr. Edmonds and colleagues assessed the safety and efficacy of EDX110 in the treatment of 148 diabetic foot ulcers in their 12-week study of 135 patients.
Patients randomly assigned to EDX110 were instructed to change their dressing every 48 hours, and patients assigned to the control group were treated with whichever available dressing was deemed the best clinical practice at that time.
The median number of dressing changes was 3.5 per week in the EDX110 group, compared with 1.6 per week in the control group.
Percent area reduction from baseline (PAR) at 12 weeks, the primary efficacy outcome, with significantly greater with EDX110 (mean, 58.7%; median, 88.6%) than with best clinical practice (mean, 37.0%; median, 46.9%), the researchers report in Wound Repair and Regeneration, online April 4.
PAR at four weeks was also significantly greater with EDX110 than with best clinical practice.
The proportion of ulcers healed at 12 weeks was 40% (30/75) with EDX110 and 26% (19/73) with best clinical practice (P=0.07).
The percentage of ulcers demonstrating reductions of at least 50% in area at week 4 was significantly higher with EDX110 (53%) than with best clinical practice (36%).
In subgroup analysis, PAR was significantly greater with EDX110 than with best clinical practice among patients whose ulcers had been present for six or fewer months or were at least 1 cm2 at baseline, but not for those whose ulcers had been present for longer or were smaller.
“The study was carried out in a ‘real world’ population and thus EDX110 is indicated in the management of diabetic foot ulcers, even when mildly infected, and as long as the ankle-brachial pressure index is above 0.5,” Dr. Edmonds said. “The results also suggest that the earlier it is used, the greater the improvement would be over current practice.”
“However,” he said, “living in the real world, the price will need to be right. If Edixomed prices this appropriately, then EDX110 could become a key part of the treatment pathway of any diabetic foot ulcer, especially when mildly infected.”
Edixomed Ltd. funded the study and had financial ties to several of the authors, including Dr. Edmonds.
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