Trial Information

Official Title: The AutoloGel™ Post-Market Surveillance (TAPS) Program

Summary

AutoloGel™ Post-Market Surveillance Program Purpose:Evaluate the incidence of hematologic and immunologic adverse events, including coagulopathies in patients with wounds to which AutoloGel™ was applied. Design:Prospective, open label, patient registry. Investigator Sites: 3 Enrollment Size: 300 Subject Population: Patients with exuding wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and for the management of mechanically or surgically-debrided wounds. Primary Objective Safety: Assess the incidence of hematologic (coagulopathies), immunologic (including anaphylaxis) and other adverse events associated with the application of AutoloGel on exuding wounds, such as leg ulcers, pressure ulcers and diabetic ulcers and during the management of mechanically or surgically-debrided wounds. Primary Safety Endpoint: Absence of coagulopathies caused by inhibitors to coagulation Factor V as determined by a significant prolongation of the prothrombin (PT) time and confirmed by severe depletion of Factor V activity with a positive Bethesda Assay for anti-Factor V functional inhibitors.

Phase: N/A

Sponsor: Cytomedix

Overall Contacts:

Suzette L Arch, BA, BS
240-499-2680
sarch@cytomedix.com

Carelyn Fyling, RN
Phone: 218-547-4142
cfyling@EOT.COM