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| Sponsored by: |
Organogenesis |
| Information provided by: | Organogenesis |
| ClinicalTrials.gov Identifier: | NCT00648674 |
Purpose
Single site clinical study utilizing the novel technology of microarrays to identify and characterize the molecular mechanisms through which Apligraf promotes healing of venous leg ulcers.
| Condition | Intervention | Phase |
|
Varicose Ulcer |
Device: Apligraf |
Phase IV |
| MedlinePlus related topics: | Leg Injuries and Disorders |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | A Prospective, Single-Site Study to Identify and Characterize the Molecular Mechanisms of Apligraf in Non-Healing Wounds of Subjects With Venous Leg Ulcers |
| Estimated Enrollment: | 15 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Apligraf
|
Device: Apligraf
Applied at Day 0, possible re-application at Week 6
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, District of Columbia | |||||
| Wound Healing Center, Georgetown University | Recruiting | ||||
| Washington, District of Columbia, United States, 20007 | |||||
| Contact: Susan Borgiasz, RN, BSN 202-444-7288 Susan.I.Borgiasz@gunet.georgetown.edu | |||||
| Principal Investigator: Christopher Attinger, MD | |||||
| Principal Investigator: John S Steinberg, DPM | |||||
| Organogenesis |
| Study Director: | Damien Bates, MD, PhD, FRACS (Plast.) | Organogenesis Inc. |
More Information
| Responsible Party: | Organogenesis Inc. ( Damien Bates, MD, PhD, Vice President Medical Affairs ) |
| Study ID Numbers: | 07-MOA-001-AG |
| First Received: | March 28, 2008 |
| Last Updated: | October 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00648674 |
| Health Authority: | United States: Institutional Review Board |
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