Status:
COMPLETED
Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
Lead Sponsor:
Shire Regenerative Medicine, Inc.
Conditions:
Venous Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
* Observe the long-term (1-year) outcomes of Dermagraft, compared with conventional treatment of four-layer compression bandaging therapy alone, in subjects who completed the ABH-Dermagraft-001-08 stu...
Eligibility Criteria
Inclusion
- Subject has completed study ABH-Dermagraft-001-08
- Subject understands study requirements
- Subject is available to participate in the 1 year-long observational follow-up.
Exclusion
- Subject who withdrew or was terminated from ABH-Dermagraft-001-08 before completion
- Subject is not available for the 1 year-long observational period.
- Subject has any condition(s) which seriously compromises the subject's ability to complete the study
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT01891760
Start Date
May 1 2010
End Date
June 1 2012
Last Update
August 21 2013
Active Locations (28)
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1
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
2
Hope Research Institute
Phoenix, Arizona, United States, 85018
3
Dr. Jagpreet S. Mukker
Fresno, California, United States, 93722
4
VA Northern California Health Care Sytem
Mather, California, United States, 95665