Clinical trial NCT01891760: Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
Official title: A Prospective, Multi-center, Longitudinal, Cohort Study of Dermagraft in Subjects With Venous Leg Ulcers: A Long-term Follow-up to the DEVO-Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Leg Ulcer
Lead sponsor: Shire Regenerative Medicine, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-03
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: Inclusion Criteria:

1. Subject has completed study ABH-Dermagraft-001-08
2. Subject understands study requirements
3. Subject is available to participate in the 1 year-long observational follow-up.

Exclusion Criteria:

1. Subject who withdrew or was terminated from ABH-Dermagraft-001-08 before completion
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

Primary outcomes:
measure: The incidence of study ulcer recurrence
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of complete study ulcer healing
timeFrame: 1 year
measure: Incidence of study ulcer infection-related events
timeFrame: 1 year
measure: Time to study ulcer recurrence
timeFrame: 1 year
measure: Change in ulcer size
timeFrame: 1 year
measure: Time to study ulcer healing
timeFrame: 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Carl T. Hayden VA Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Fresno
country: United States
facility: Dr. Jagpreet S. Mukker
state: California
city: Mather
country: United States
facility: VA Northern California Health Care Sytem
state: California
city: New Haven
country: United States
facility: North Amercian Center for Limb Preservation
state: Connecticut
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: South Miami
country: United States
facility: Doctor's Research Network
state: Florida
city: Tamarac
country: United States
facility: South Florida Wound Care Group, P.A.
state: Florida
city: Saginaw
country: United States
facility: Covenant Wound Healing Center
state: Michigan
city: Las Vegas
country: United States
facility: Advanced Foot & Ankle Center
state: Nevada
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Erie
country: United States
facility: Saint Vincent Health Center
state: Pennsylvania
city: Tallin
country: Estonia
facility: East-Tallinn Central Hospital Department of Rheumatology
city: Freiburg
country: Germany
facility: Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt
city: Hamburg
country: Germany
facility: Gemeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter
city: Krakow
country: Poland
facility: AKMed Medical Center, Department of Vascular Surgery
city: Krakow
country: Poland
facility: Vascular Surgery, Tomasz Aleksiejew-Kleszczynski (Chirurgia Naczyn)
city: Lodz
country: Poland
facility: NZOZ "'Dermed" Medical Center (Centrum Medyczne Sp. z o.o.
city: Lublin
country: Poland
facility: "Medicos" Medical Center
city: Nowy Sacz
country: Poland
facility: "NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology
city: Wroclaw
country: Poland
facility: NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wrocławskie Centrum Zdrowia)
city: Benoni
country: South Africa
facility: Lakeview Hospital
city: Bloemfontein
country: South Africa
facility: Josha Research
city: Durban
country: South Africa
facility: Randles Road Medical Centre
city: Port Elizabeth
country: South Africa
facility: GCT-Mercantile Clinical Trial Centre
city: Potchefstroom
country: South Africa
facility: Cachetnied Medical Centre
city: Worcester
country: South Africa
facility: Boland Ethical Research Group
city: Cardiff
country: United Kingdom
facility: Cardiff University Dept. of Wound Healing School of Medicine
Study officials:
affiliation: Shire Regenerative Medicine
name: Mollie Carter, MD
role: STUDY_DIRECTOR
References: