A RANDOMIZED, CONTROLLED, MULTICENTER, DOSE-RESPONSE TRIAL OF ACTIVATED PLATELET SUPERNATENT, TOPICAL CT-102 IN CHRONIC, NONHEALING, DIABETIC WOUNDS

Ninety-seven patients were entered into this randomized, double-blind, placebo controlled, dose-ranging study exploring the efficacy and saf ety of a thrombin induced, platelet releasate (CT-102, 0.1, 0.033 and 0.01 dilutions) applied daily to diabetic ulcers. Sixteen of the patie nts did not meet the protocol criteria and were removed from the study . Eleven additional patients were excluded from the efficacy analyses due to non-compliance with the treatment and protocol. The treatment w as continued for up to 20 weeks or until the wounds were completely he aled (functionally mature epithelium covering the wound). Efficacy was determined by evaluating complete healing and reduction in area and v olume of the wound in the remaining 70 patients. Each dilution of CT-1 02 stimulated a greater proportion of wounds to heal than placebo; the best results were achieved with the 0.01 dilution. In this group 80% of the wounds were healed (functionally mature) compared with 29% in t he placebo group (p=0.01). Volume reduction was 94.9% in the 0.01 dilu tion treated group (p=0.01) and 82.7% in the placebo group (p=0.005). Significant differences between the CT-102 (all dilutions) and placebo groups were also seen for percent patients healed (p=0.005) at the fi nal visit. No differences or trends were found in the adverse event pr ofiles between active product and placebo.