Enrolment complete for venous leg ulcer healing product
This article was originally published in Clinica
Executive Summary
New York firm Ortec International has completed patient enrolment for its confirmatory trial for the use of cryopreserved OrCel - a regenerative product for chronic wounds - to treat venous leg ulcers. The firm hopes to validate results from its pivotal trial, where 59% of patients treated with cryopreserved OrCel achieved wound closure, compared with 36% of patients receiving standard care. OrCel is composed of a collagen sponge containing cells that secrete growth factors and cytokines normally found in acute wounds. Ortec hopes to submit a PMA application to the FDA by mid July 2006, after the 12-week treatment phase is completed.