The new study, which Slade co-authored, is phase 2 research designed to understand how well a treatment works. A third phase of research, which compares a new treatment to an existing treatment, is needed before the federal government will approve a drug.
In the current study, researchers gave different doses of the treatment to 178 patients and a placebo to 50 patients. The participants had the most healing on a low dose given every two weeks: After 12 weeks, ulcers had healed in 70 percent of patients, compared with 46 percent of those who received a placebo.
"The treatment effect was seen very rapidly, with wounds beginning to heal already in the first week," Slade said.
The researchers found that those who received the placebo were more likely to report problems -- potential side effects -- than those who got the actual treatment. The study says most of the problems, such as new ulcers, were "non-serious" and most were resolved.
The findings "offer great hope for patients with chronic wounds," said Dr. Matthias Augustin, director of the Institute for Health Services Research in Dermatology and Nursing at the University Clinics of Hamburg in Germany, who wrote a commentary accompanying the study.
With non-healing ulcers, prolonged traditional treatments drive up cost without helping patients, and new products need to be evaluated for wound healing and cost effectiveness, he noted in the commentary.
The study appears online Aug. 3 in The Lancet.
More information
For more about skin ulcers, try the U.S. National Library of Medicine.
SOURCES: Herbert B. Slade, M.D., chief medical offic
'/>"/>
| Copyright©2012 ScoutNews,LLC. All rights reserved |