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

Primary Purpose

Venous Leg Ulcer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dermagraft
Profore
Sponsored by
Shire Regenerative Medicine, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carl T. Hayden VA Medical Center
  • Hope Research Institute
  • Dr. Jagpreet S. Mukker
  • VA Northern California Health Care Sytem
  • North Amercian Center for Limb Preservation
  • University of Miami Miller School of Medicine
  • Doctor's Research Network
  • South Florida Wound Care Group, P.A.
  • Covenant Wound Healing Center
  • Advanced Foot & Ankle Center
  • Stony Brook University Medical Center
  • Saint Vincent Health Center
  • East-Tallinn Central Hospital Department of Rheumatology
  • Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt
  • Gemeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter
  • AKMed Medical Center, Department of Vascular Surgery
  • Vascular Surgery, Tomasz Aleksiejew-Kleszczynski (Chirurgia Naczyn)
  • NZOZ "'Dermed" Medical Center (Centrum Medyczne Sp. z o.o.
  • "Medicos" Medical Center
  • "NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology
  • NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wrocławskie Centrum Zdrowia)
  • Lakeview Hospital
  • Josha Research
  • Randles Road Medical Centre
  • GCT-Mercantile Clinical Trial Centre
  • Cachetnied Medical Centre
  • Boland Ethical Research Group
  • Cardiff University Dept. of Wound Healing School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment

Reference Therapy

Arm Description

Dermagraft - Allogenic Neonatal Dermal Fibroblasts Seeded on poly(glycolide-co-L-lactide)(PGLLA)Scaffold

Profore - Four-layer compression bandaging therapy

Outcomes

Primary Outcome Measures

The incidence of study ulcer recurrence

Secondary Outcome Measures

Incidence of complete study ulcer healing
Incidence of study ulcer infection-related events
Time to study ulcer recurrence
Change in ulcer size
Time to study ulcer healing

Full Information

First Posted
June 28, 2013
Last Updated
August 9, 2013
Sponsor
Shire Regenerative Medicine, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01891760
Brief Title
Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
Acronym
LTFU
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

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire Regenerative Medicine, Inc.

4. Oversight

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Dermagraft - Allogenic Neonatal Dermal Fibroblasts Seeded on poly(glycolide-co-L-lactide)(PGLLA)Scaffold
Arm Title
Reference Therapy
Arm Type
Active Comparator
Arm Description
Profore - Four-layer compression bandaging therapy
Intervention Type
Device
Intervention Name(s)
Dermagraft
Intervention Description
Dermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum).
Intervention Type
Device
Intervention Name(s)
Profore
Intervention Description
Four-layer compression bandaging therapy.
Primary Outcome Measure Information:
Title
The incidence of study ulcer recurrence
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Incidence of complete study ulcer healing
Time Frame
1 year
Title
Incidence of study ulcer infection-related events
Time Frame
1 year
Title
Time to study ulcer recurrence
Time Frame
1 year
Title
Change in ulcer size
Time Frame
1 year
Title
Time to study ulcer healing
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mollie Carter, MD
Organizational Affiliation
Shire Regenerative Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Carl T. Hayden VA Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Dr. Jagpreet S. Mukker
City
Fresno
State/Province
California
ZIP/Postal Code
93722
Country
United States
Facility Name
VA Northern California Health Care Sytem
City
Mather
State/Province
California
ZIP/Postal Code
95665
Country
United States
Facility Name
North Amercian Center for Limb Preservation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06515
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Doctor's Research Network
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
South Florida Wound Care Group, P.A.
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Covenant Wound Healing Center
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Advanced Foot & Ankle Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Saint Vincent Health Center
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16544
Country
United States
Facility Name
East-Tallinn Central Hospital Department of Rheumatology
City
Tallin
ZIP/Postal Code
11312
Country
Estonia
Facility Name
Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt
City
Freiburg
ZIP/Postal Code
D-79100
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter
City
Hamburg
ZIP/Postal Code
D-22177
Country
Germany
Facility Name
AKMed Medical Center, Department of Vascular Surgery
City
Krakow
ZIP/Postal Code
30-312
Country
Poland
Facility Name
Vascular Surgery, Tomasz Aleksiejew-Kleszczynski (Chirurgia Naczyn)
City
Krakow
ZIP/Postal Code
30-347
Country
Poland
Facility Name
NZOZ "'Dermed" Medical Center (Centrum Medyczne Sp. z o.o.
City
Lodz
ZIP/Postal Code
90-265
Country
Poland
Facility Name
"Medicos" Medical Center
City
Lublin
ZIP/Postal Code
20-844
Country
Poland
Facility Name
"NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology
City
Nowy Sacz
ZIP/Postal Code
33-300
Country
Poland
Facility Name
NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wrocławskie Centrum Zdrowia)
City
Wroclaw
ZIP/Postal Code
54-610
Country
Poland
Facility Name
Lakeview Hospital
City
Benoni
ZIP/Postal Code
1500
Country
South Africa
Facility Name
Josha Research
City
Bloemfontein
ZIP/Postal Code
9300
Country
South Africa
Facility Name
Randles Road Medical Centre
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
GCT-Mercantile Clinical Trial Centre
City
Port Elizabeth
ZIP/Postal Code
6014
Country
South Africa
Facility Name
Cachetnied Medical Centre
City
Potchefstroom
ZIP/Postal Code
2530
Country
South Africa
Facility Name
Boland Ethical Research Group
City
Worcester
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Cardiff University Dept. of Wound Healing School of Medicine
City
Cardiff
ZIP/Postal Code
CF 14 4XN
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.gov/ct2/show/study/NCT00909870?term=DEVO&rank=1&view=record
Description
ClinicalTrials.gov registry for the Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers (DEVO)

Learn more about this trial

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

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