Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers

Completed · Phase 3

Conditions studied: Venous Leg Ulcer

In brief

* 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)

Key facts

Study ID

NCT01891760

Run by

Shire Regenerative Medicine, Inc.

People needed

225

Starts

2010-05-01

Expected to finish

2012-06-01

Last updated by the study team

2013-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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