The AutoloGel™ Post-Market Surveillance (TAPS) Program (TAPS)
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|ClinicalTrials.gov Identifier: NCT00762138|
Recruitment Status : Terminated (Discontinued due to favorable results)
First Posted : September 30, 2008
Last Update Posted : February 26, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Wounds Leg Ulcers Pressure Ulcers Diabetic Foot Ulcers||Device: AutoloGel System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The AutoloGel™ Post-Market Surveillance (TAPS) Program|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||June 2012|
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
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762138
|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|