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.
Diabetic Foot Ulcers
Device: AutoloGel System
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||The AutoloGel™ Post-Market Surveillance (TAPS) Program|
- Assess the incidence of hematological immunologic other ae's association with the application of AutoloGel on exuding wounds such as leg ulcers pressure ulcers and diabetics ulcers and during the management of mechanically or surgically debrided wounds [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Absence of coagulopathies caused by inhibitors to coagulation Factor V as determined by a significant prolongation of the (PT) time. Depletion of Factor V activity with a positive Bethesda Assay [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Study Completion Date:||June 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Autologel System produces platelet rich plasma gel
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 with diabetic ulcers Bowel and bladder care for subjects with pressure ulcers at risk for contamination Management of underlying disease
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|United States, Georgia|
|Aiyan Diabetes Center|
|Augusta, Georgia, United States, 30809|
|United States, Texas|
|Providence Wound Institute|
|El Paso, Texas, United States, 79902|
|Principal Investigator:||Macy G Hall, MD||Speciality Hospital of Washington - Hadley|
|Principal Investigator:||John G Martinez, MD||VA Southern Nevda|
|Principal Investigator:||Janaki Nadarajah, DPM||Aiyan Diabetes Center|
|Principal Investigator:||Gregory H Szeyko, MD||Providence Wound Institute|