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Cytomedix says AutoloGel healed 68% of diabetic foot ulcers
By Elaine Rigoli
Tampa, Fla., June 28 - Cytomedix, Inc. said the results of its diabetic foot ulcer prospective trial for the AutoloGel system documented that in the 40 wounds per-protocol group, 13 out of 19 (68.4%) of the AutoloGel and nine out of 21 (42.9%) of the control wounds healed (full closure).
After adjusting for wound size outliers, the company said significantly more AutoloGel (13 out of 16, 81.3%) than control gel (eight out of 19, 42.1%) treated wounds healed.
"The healing rates of AutoloGel at 81.3% for the most common wound sizes in the study and 68.4% for all wound sizes are very competitive with, or better than, most other wound care products cleared by the FDA and covered by Medicare reimbursement," chairman and chief executive officer Kshitij Mohan said in a news release.
"The control group patients were not on placebo; rather, they were treated using a saline gel cleared by the FDA for use on chronic and surgical wounds. It is important to point out that if the control group patients healed at the originally anticipated rate of 20% to 30% (which was based on published literature), the difference between the healing rates in the AutoloGel group versus the control group would have been even more strongly statistically significant," Mohan added.
Researchers also said AutoloGel may not only enhance healing, but it may also prevent lower extremity amputations caused by nonhealing wounds.
There are 2 million cases of diabetic foot ulcers in the United States at any one time, and statistics show that between 14% and 24% of the patients will require amputations, the release said.
Cytomedix is a biotechnology company located in Rockville, Md.
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