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Sponsors and Collaborators: |
Cytomedix CTI Clinical Trial and Consulting Services |
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Information provided by: | Cytomedix |
ClinicalTrials.gov Identifier: | NCT00762138 |
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 | Intervention |
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Wounds Leg Ulcers Pressure Ulcers Diabetic Foot Ulcers |
Device: AutoloGel System |
Study Type: | Interventional |
Study Design: | Open Label, Historical Control, Single Group Assignment, Safety Study |
Official Title: | The AutoloGel™ Post-Market Surveillance (TAPS) Program |
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) |
Ages Eligible for Study: | 18 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Patients with the following abnormal laboratory test levels
Contact: Suzette L Arch, BA, BS | 240-499-2680 | sarch@cytomedix.com |
Contact: Carelyn Fyling, RN | 218-547-4142 | cfyling@EOT.COM |
United States, District of Columbia | |
Specialty Hospital of Washington - Hadley | Recruiting |
Washington, District of Columbia, United States, 20032 | |
Contact: Anne Coles, RN 202-574-5700 | |
Contact: Sandra Sheehan, NP 202-574-5700 | |
Principal Investigator: Macy G Hall, MD | |
Sub-Investigator: William J Brownlee, MD | |
United States, Nevada | |
VA Southern Nevda | Recruiting |
Las Vegas, Nevada, United States, 89191 | |
Contact: Paula Cooper, RN 702-653-2780 paula.cooper2@va.gov | |
Principal Investigator: John G Martinez, MD |
Principal Investigator: | Macy G Hall, MD | Speciality Hospital of Washington - Hadley |
Principal Investigator: | John G Martinez, MD | VA Southern Nevda |
Responsible Party: | Cytomedix ( Martin Rosendale, CEO ) |
Study ID Numbers: | CM 306 |
Study First Received: | September 24, 2008 |
Last Updated: | July 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00762138 History of Changes |
Health Authority: | United States: VA Loma Linda Healthcare System |
Platelet rich plasma wounds leg ulcers |
pressure ulcers diabetic ulcers management of mechanically or surgically-debrided wounds |
Foot Ulcer Diabetic Neuropathies Skin Diseases Ulcer Vascular Diseases Diabetes Mellitus Endocrine System Diseases Foot Diseases |
Diabetic Angiopathies Endocrinopathy Skin Ulcer Pressure Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
Foot Ulcer Diabetic Neuropathies Skin Diseases Ulcer Diabetes Mellitus Vascular Diseases Endocrine System Diseases Foot Diseases |
Diabetic Angiopathies Pathologic Processes Cardiovascular Diseases Skin Ulcer Pressure Ulcer Diabetes Complications Leg Ulcer Diabetic Foot |