Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
LTFU
A Prospective, Multi-center, Longitudinal, Cohort Study of Dermagraft in Subjects With Venous Leg Ulcers: A Long-term Follow-up to the DEVO-Trial
1 other identifier
interventional
225
6 countries
28
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 study.
- Study Hypothesis: N/A (Long-term follow-up study)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2010
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 28, 2013
CompletedFirst Posted
Study publicly available on registry
July 3, 2013
CompletedAugust 21, 2013
August 1, 2013
2.1 years
June 28, 2013
August 9, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of study ulcer recurrence
1 year
Secondary Outcomes (5)
Incidence of complete study ulcer healing
1 year
Incidence of study ulcer infection-related events
1 year
Time to study ulcer recurrence
1 year
Change in ulcer size
1 year
Time to study ulcer healing
1 year
Study Arms (2)
Treatment
EXPERIMENTALDermagraft - Allogenic Neonatal Dermal Fibroblasts Seeded on poly(glycolide-co-L-lactide)(PGLLA)Scaffold
Reference Therapy
ACTIVE COMPARATORProfore - Four-layer compression bandaging therapy
Interventions
Dermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Carl T. Hayden VA Medical Center
Phoenix, Arizona, 85012, United States
Hope Research Institute
Phoenix, Arizona, 85018, United States
Dr. Jagpreet S. Mukker
Fresno, California, 93722, United States
VA Northern California Health Care Sytem
Mather, California, 95665, United States
North Amercian Center for Limb Preservation
New Haven, Connecticut, 06515, United States
University of Miami Miller School of Medicine
Miami, Florida, 33125, United States
Doctor's Research Network
South Miami, Florida, 33143, United States
South Florida Wound Care Group, P.A.
Tamarac, Florida, 33321, United States
Covenant Wound Healing Center
Saginaw, Michigan, 48602, United States
Advanced Foot & Ankle Center
Las Vegas, Nevada, 89119, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Saint Vincent Health Center
Erie, Pennsylvania, 16544, United States
East-Tallinn Central Hospital Department of Rheumatology
Tallinn, 11312, Estonia
Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt
Freiburg im Breisgau, D-79100, Germany
Gemeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter
Hamburg, D-22177, Germany
AKMed Medical Center, Department of Vascular Surgery
Krakow, 30-312, Poland
Vascular Surgery, Tomasz Aleksiejew-Kleszczynski (Chirurgia Naczyn)
Krakow, 30-347, Poland
NZOZ "'Dermed" Medical Center (Centrum Medyczne Sp. z o.o.
Lodz, 90-265, Poland
"Medicos" Medical Center
Lublin, 20-844, Poland
"NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology
Nowy Sącz, 33-300, Poland
NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wrocławskie Centrum Zdrowia)
Wroclaw, 54-610, Poland
Lakeview Hospital
Benoni, 1500, South Africa
Josha Research
Bloemfontein, 9300, South Africa
Randles Road Medical Centre
Durban, 4091, South Africa
GCT-Mercantile Clinical Trial Centre
Port Elizabeth, 6014, South Africa
Cachetnied Medical Centre
Potchefstroom, 2530, South Africa
Boland Ethical Research Group
Worcester, 6850, South Africa
Cardiff University Dept. of Wound Healing School of Medicine
Cardiff, CF 14 4XN, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mollie Carter, MD
Shire Regenerative Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2013
First Posted
July 3, 2013
Study Start
May 1, 2010
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
August 21, 2013
Record last verified: 2013-08