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

Phase 3

Completed

Conditions: Venous Leg Ulcer

Interventions: Device: Dermagraft
Device: Profore

Registration Number: NCT01891760

Lead Sponsor: Shire Regenerative Medicine, Inc.

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)

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 225

Inclusion Criteria

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 Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Dermagraft	Dermagraft - Allogenic Neonatal Dermal Fibroblasts Seeded on poly(glycolide-co-L-lactide)(PGLLA)Scaffold
Reference Therapy	Profore	Profore - Four-layer compression bandaging therapy

Primary Outcome Measures

Name	Time	Method
The incidence of study ulcer recurrence	1 year

Secondary Outcome Measures

Name	Time	Method
Time to study ulcer healing	1 year
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

Trial Locations

Locations (28): Dr. Jagpreet S. Mukker
🇺🇸
Fresno, California, United States
University of Miami Miller School of Medicine
🇺🇸
Miami, Florida, United States
Stony Brook University Medical Center
🇺🇸
Stony Brook, New York, United States
Hope Research Institute
🇺🇸
Phoenix, Arizona, United States
NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wrocławskie Centrum Zdrowia)
🇵🇱
Wroclaw, Poland
"Medicos" Medical Center
🇵🇱
Lublin, Poland
Advanced Foot & Ankle Center
🇺🇸
Las Vegas, Nevada, United States
AKMed Medical Center, Department of Vascular Surgery
🇵🇱
Krakow, Poland
Carl T. Hayden VA Medical Center
🇺🇸
Phoenix, Arizona, United States
Covenant Wound Healing Center
🇺🇸
Saginaw, Michigan, United States
North Amercian Center for Limb Preservation
🇺🇸
New Haven, Connecticut, United States
VA Northern California Health Care Sytem
🇺🇸
Mather, California, United States
Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt
🇩🇪
Freiburg, Germany
South Florida Wound Care Group, P.A.
🇺🇸
Tamarac, Florida, United States
Saint Vincent Health Center
🇺🇸
Erie, Pennsylvania, United States
Doctor's Research Network
🇺🇸
South Miami, Florida, United States
East-Tallinn Central Hospital Department of Rheumatology
🇪🇪
Tallin, Estonia
Gemeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter
🇩🇪
Hamburg, Germany
Vascular Surgery, Tomasz Aleksiejew-Kleszczynski (Chirurgia Naczyn)
🇵🇱
Krakow, Poland
"NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology
🇵🇱
Nowy Sacz, Poland
NZOZ "'Dermed" Medical Center (Centrum Medyczne Sp. z o.o.
🇵🇱
Lodz, Poland
Josha Research
🇿🇦
Bloemfontein, South Africa
GCT-Mercantile Clinical Trial Centre
🇿🇦
Port Elizabeth, South Africa
Cardiff University Dept. of Wound Healing School of Medicine
🇬🇧
Cardiff, United Kingdom
Lakeview Hospital
🇿🇦
Benoni, South Africa
Randles Road Medical Centre
🇿🇦
Durban, South Africa
Cachetnied Medical Centre
🇿🇦
Potchefstroom, South Africa
Boland Ethical Research Group
🇿🇦
Worcester, South Africa