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Two-layer Dressing Helps to treat difficult Diabetic Foot Ulcers.
Diabetics with difficult-to-treat, neuropathic foot ulcers demonstrated a higher rate of complete healing following treatment with OrCel than patients who received the current standard of care, according to new study results.
The product — Ortec International, Inc.’s "OrCel" — is essentially a collagen sponge containing human cells. It was approved by the U.S. Food and Drug Administration (FDA) in 2001, to treat areas where skin has been removed from burn victims for grafting elsewhere.
Dr. Scott Lipkin of Lehigh Valley Hospital in Allentown, Pennsylvania, led a 12-week study of 40 diabetic patients with chronic foot ulcers.
Possible study participants were first screened for two weeks while they received standard treatment for foot ulcers. If the patients began to respond, they were excluded from the study, Ortec President and COO Dr. Costa Papastephanou told Reuters Health. "We were looking for patients with ulcers that would not be healed by existing modalities," he said.
The 20 patients then were treated with the OrCel dressing as well as a moist saline gauze for six weeks, followed by six weeks of standard care or until complete healing was achieved. OrCel was changed weekly during the first six weeks.
The control group received only standard of care for 12 weeks.
The results are reported in the journal Wounds for July 2003. After 12 weeks, 7 of the 20 ulcers treated with OrCel were completely healed compared with 4 of 20 in the control group.
In the OrCel-treated group, wound closure was achieved quickly following treatment and then gradually slowed during the first three weeks of care. In the control group, the rate of wound closure was constantly low during the entire 12-week study. Wound 2003;15:230-236.
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