Re: Clinical Trials Updates
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: 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
Study Type: Interventional
Study Design: Other, Open Label, Historical Control, Single Group Assignment, Safety Study
Official Title: The AutoloGel™ Post-Market Surveillance (TAPS) Program
Further study details as provided by Cytomedix:
Primary Outcome Measures:
Assess the incidence of hematological immunologic other ae's assoc with the application of AutoloGel on exuding wounds such as leg ulcers pressure ulcers and diabetics ulcers and during the management of mechchanically or surgically debrided wounds [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
Absence of coagulopathies caused by inhibitors to coagulation Factor V as determ. by a significant prolongation of the (PT) time and confirmed by sever depletion of Factor V activity with a positive Bethesda Assay for anti-Factor V functional inhibitors [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 300
Study Start Date: September 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Device: AutoloGel System
The AutoloGel™ System may be used for chronic or surgically-debrided wounds up to twice a week for eight (8) weeks. The treating health care practitioner may elect to continue the treatment up to twelve (12) weeks. The AutoloGel™ System should be used in conjunction with standard of care procedures for comprehensive wound management , such as:
Removal of necrotic or infected tissue Off-loading Compression therapy for venous stasis ulcers Establishment of adequate blood circulation Maintenance of a moist wound environment Management of wound infection Wound cleansing Nutritional support, including blood glucose control for subjects