Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
NCT ID: NCT01891760
Last Updated: 2013-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
225 participants
INTERVENTIONAL
2010-05-31
2012-06-30
Brief Summary
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* Study Hypothesis: N/A (Long-term follow-up study)
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
Dermagraft - Allogenic Neonatal Dermal Fibroblasts Seeded on poly(glycolide-co-L-lactide)(PGLLA)Scaffold
Dermagraft
Dermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum).
Reference Therapy
Profore - Four-layer compression bandaging therapy
Profore
Four-layer compression bandaging therapy.
Interventions
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Dermagraft
Dermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum).
Profore
Four-layer compression bandaging therapy.
Eligibility Criteria
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Inclusion Criteria
2. Subject understands study requirements
3. Subject is available to participate in the 1 year-long observational follow-up.
Exclusion Criteria
2. Subject is not available for the 1 year-long observational period.
3. Subject has any condition(s) which seriously compromises the subject's ability to complete the study
18 Years
ALL
No
Sponsors
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Shire Regenerative Medicine, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mollie Carter, MD
Role: STUDY_DIRECTOR
Shire Regenerative Medicine
Locations
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Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States
Hope Research Institute
Phoenix, Arizona, United States
Dr. Jagpreet S. Mukker
Fresno, California, United States
VA Northern California Health Care Sytem
Mather, California, United States
North Amercian Center for Limb Preservation
New Haven, Connecticut, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Doctor's Research Network
South Miami, Florida, United States
South Florida Wound Care Group, P.A.
Tamarac, Florida, United States
Covenant Wound Healing Center
Saginaw, Michigan, United States
Advanced Foot & Ankle Center
Las Vegas, Nevada, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Saint Vincent Health Center
Erie, Pennsylvania, United States
East-Tallinn Central Hospital Department of Rheumatology
Tallinn, , Estonia
Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt
Freiburg im Breisgau, , Germany
Gemeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter
Hamburg, , Germany
AKMed Medical Center, Department of Vascular Surgery
Krakow, , Poland
Vascular Surgery, Tomasz Aleksiejew-Kleszczynski (Chirurgia Naczyn)
Krakow, , Poland
NZOZ "'Dermed" Medical Center (Centrum Medyczne Sp. z o.o.
Lodz, , Poland
"Medicos" Medical Center
Lublin, , Poland
"NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology
Nowy Sącz, , Poland
NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wrocławskie Centrum Zdrowia)
Wroclaw, , Poland
Lakeview Hospital
Benoni, , South Africa
Josha Research
Bloemfontein, , South Africa
Randles Road Medical Centre
Durban, , South Africa
GCT-Mercantile Clinical Trial Centre
Port Elizabeth, , South Africa
Cachetnied Medical Centre
Potchefstroom, , South Africa
Boland Ethical Research Group
Worcester, , South Africa
Cardiff University Dept. of Wound Healing School of Medicine
Cardiff, , United Kingdom
Countries
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Related Links
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ClinicalTrials.gov registry for the Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers (DEVO)
Other Identifiers
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ABH-Dermagraft-001-09
Identifier Type: -
Identifier Source: org_study_id