Research Study Summary
A clinical study for patients with Wounds, Leg Ulcers, Pressure Ulcers or Diabetic Foot Ulcers
Research Study Title
The AutoloGel™ Post-Market Surveillance (TAPS) Program
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:
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.
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