The AutoloGel™ Post-Market Surveillance (TAPS) Program

Stopped early · Not applicable

Conditions studied: Wounds, Leg Ulcers, Pressure Ulcers, Diabetic Foot Ulcers

In brief

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.

Key facts

Study ID

NCT00762138

Run by

Cytomedix

People needed

131

Starts

2008-09-01

Expected to finish

2012-06-01

Last updated by the study team

2014-02-26

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Aiyan Diabetes Center — Augusta, Georgia, United States
• Providence Wound Institute — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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