Status:
TERMINATED
The AutoloGel™ Post-Market Surveillance (TAPS) Program
Lead Sponsor:
Cytomedix
Collaborating Sponsors:
CTI Clinical Trial and Consulting Services
Conditions:
Wounds
Leg Ulcers
Eligibility:
All Genders
18-95 years
Phase:
NA
Brief 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 appl...
Detailed Description
Device Name. The device subject to the Post-Market Surveillance (PMS) Program is the AutoloGel™ System which has been cleared for marketing by the Food and Drug Administration (FDA) in the applicatio...
Eligibility Criteria
Inclusion
- A patient who meets all the following criteria will be enrolled in the postmarket surveillance program:
- Presents with exuding wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically-debrided wounds.
- Male or female subject of any race, and 18 to 95 years old.
Exclusion
- Study investigator(s) shall follow the Contraindications, Precautions, and Warnings relevant to subjects enrolled for treatment of wounds;
- Subjects will be excluded from the trial if any of the following criteria are met:
- If the Subject is on Coumadin medication (or another medication that is known to affect a potential coagulopathy) and has an elevated PT (prothrombin time) at the alert level at baseline, he/she will NOT be enrolled in the surveillance program.
- Ensure the patient does not have any Contraindications as noted in the AutoloGel System Instructions for use, specifically:
- Patients known to be sensitive to components and / or materials of bovine origin
- Patients on chemotherapeutic agents
- Patients with the following abnormal laboratory test levels
- hemoglobin \<10.5 g/dL
- platelet count \<100 x 109/L
- serum albumin level \< 2.5 g/dL
- Wounds due to malignancy
- Wounds with active clinically diagnosed infection
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00762138
Start Date
September 1 2008
End Date
June 1 2012
Last Update
February 26 2014
Active Locations (2)
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1
Aiyan Diabetes Center
Augusta, Georgia, United States, 30809
2
Providence Wound Institute
El Paso, Texas, United States, 79902