New data presented in Glasgow at EWMA 2007 confirmed the efficacy of Xelma®, a new wound care product from Mölnlycke Health Care, in the treatment of hard-to-heal venous leg ulcers (VLUs). The data shows that Xelma® increases the rate of healing and reduces pain in patients with hard-to-heal ulcers. Professor Marco Romanelli, principal investigator, consultant dermatologist and head of Wound Healing Services at the University of Pisa in Italy, says: "Xelma® offers patients greatly improved quality of life, and offers physicians a novel, effective, bioactive treatment."
Venous leg ulcers are among the most common chronic wounds and those with diabetes or vascular diseases are particularly at risk. Approximately 1-2% of the whole population, and 3-5% of the population over the age of 65, will suffer from a leg ulcer during their lifetime. Over 20% of leg ulcers remain unhealed after one year, despite standard care. Venous leg ulceration has been estimated to cost the NHS £400m per year, with hard-to-heal wounds incurring double the expense compared to wounds that heal normally.
Professor Peter Vowden, key investigator and head of the Department of Vascular Surgery at Bradford Royal Infirmary, says: "Improved understanding of the pathophysiology of wound healing has enabled the development of therapies such as moist wound healing and biologically based products, however, more effective therapies are required to address the wounds that fail to heal in a timely manner."
In hard-to-heal wounds the extracellular matrix (ECM) is degraded, leading to reduced cell proliferation, migration and secretion of growth factors and as a consequence the wound cannot heal.
Xelma® contains amelogenin protein which, when applied to the wound bed of hard-to-heal wounds, acts as a temporary extracellular matrix. Applying Xelma® once weekly restores damaged ECM, providing adhesion sites for cells, thus promoting wound healing. Professor Vowden comments: "Xelma® is not currently being used in as many cases as it could be, but hopefully this will change as both nurses and physicians become more aware of its benefits."
A randomised controlled trial, published in the Journal of Wound Care, has demonstrated that Xelma® is effective in promoting an increased rate of healing in hard-to-heal VLUs over a 12-week period. Patients eligible for inclusion were those at risk of delayed healing. Ulcers had to be at least six months old and at least 10cm2. A total of 83 patients were randomised to receive high compression alone (control group) or high compression plus amelogenin (amelogenin group).
This preliminary 12-week data demonstrated that Xelma® is associated with a greater percentage reduction in ulcer size, compared to the control group (mean reduction of 33.1% vs. 11.1%; multiple regression P=0.03). A total of 47.6% of patients in the Xelma® group had a greater than 50% reduction in ulcer size, compared with 19.5% of patients in the control group (P=0.01).
The 12-week follow-up results were presented at this year's EWMA conference by Professor Vowden. After 24 weeks the difference between groups was significant with a mean reduction in ulcer size of 48.7% in the amelogenin group compared with a mean 21.1% reduction in the control group (P=0.02).
Dr Romanelli says: "The group receiving amelogenin also performed significantly better in a number of secondary endpoints, including pain related to the disease, reduction in pain at dressing changes, and in levels of exudate." He added that pain control was excellent after just a few weeks of Xelma® application. This was paramount to patients with hard-to-heal wounds as the pain they felt affects day-to-day activities, such as walking and sleeping.
Professor Vowden concluded: "Xelma® offers a biologically active treatment option, providing new hope to physicians caring for patients with hard-to-heal wounds."