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Clinical Res.
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Safety and efficacy of Orcel in a multicenter prospectively controlled, randomized clinical trial of venous leg ulcers Robert Kirsner, MD, PhD, Kazem Kazempour, PhD We performed a multi-center, double-blind, randomized, controlled, 12-week clinical trial to evaluate the safety and efficacy of cryopreserved OrCel¨ (Ortec International, New York, NY) combined with compression therapy (standard care), versus standard care alone, for chronic venous leg ulcers. We assessed wound size weekly (by investigators and by computerized planimetry) and also evaluated ulcer recurrence during follow-up, pain (using a 10 cm visual analogue scale), and Quality of Life (QOL) using the SF-36. Safety evaluations included rates of adverse events, signs and symptoms of infection, immunologic assays for detection of anti-collagen or HLA-cytolytic antibodies, routine clinical laboratory parameters, and vital signs. After assessing wound depth, we further evaluated those whose wounds had depths (61 patients) typical of venous ulcers. We found 59% (19/32) of wounds treated with OrCel achieved complete healing at week 12 compared to 36% (10/28) in the Standard Care group. This 64% improvement over standard care was statistically significant (P=0.034). Patients treated with OrCel had significantly faster healing (P=0.017), having a median time to healing of 57 days and a faster rate of ulcer healing (P<0.0001). There were no differences in the incidence or type of adverse events, including infections, or other safety parameters (immunologic and lab tests, vital signs) between the two treatment groups. In conclusion, when combined with compression therapy, more ulcers treated with OrCel healed and did so faster. |
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