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

August 9, 2013 updated by: Shire Regenerative Medicine, Inc.

A Prospective, Multi-center, Longitudinal, Cohort Study of Dermagraft in Subjects With Venous Leg Ulcers: A Long-term Follow-up to the DEVO-Trial

  • 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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tallin, Estonia, 11312
        • East-Tallinn Central Hospital Department of Rheumatology
  • Germany
      • Freiburg, Germany, D-79100
        • Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt
      • Hamburg, Germany, D-22177
        • Gemeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter
  • Poland
      • Krakow, Poland, 30-312
        • AKMed Medical Center, Department of Vascular Surgery
      • Krakow, Poland, 30-347
        • Vascular Surgery, Tomasz Aleksiejew-Kleszczynski (Chirurgia Naczyn)
      • Lodz, Poland, 90-265
        • NZOZ "'Dermed" Medical Center (Centrum Medyczne Sp. z o.o.
      • Lublin, Poland, 20-844
        • "Medicos" Medical Center
      • Nowy Sacz, Poland, 33-300
        • "NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology
      • Wroclaw, Poland, 54-610
        • NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wrocławskie Centrum Zdrowia)
  • South Africa
      • Benoni, South Africa, 1500
        • Lakeview Hospital
      • Bloemfontein, South Africa, 9300
        • Josha Research
      • Durban, South Africa, 4091
        • Randles Road Medical Centre
      • Port Elizabeth, South Africa, 6014
        • GCT-Mercantile Clinical Trial Centre
      • Potchefstroom, South Africa, 2530
        • Cachetnied Medical Centre
      • Worcester, South Africa, 6850
        • Boland Ethical Research Group
  • United Kingdom
      • Cardiff, United Kingdom, CF 14 4XN
        • Cardiff University Dept. of Wound Healing School of Medicine
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • HOPE Research Institute
      • Phoenix, Arizona, United States, 85012
        • Carl T. Hayden VA Medical Center
    • California
      • Fresno, California, United States, 93722
        • Dr. Jagpreet S. Mukker
      • Mather, California, United States, 95665
        • VA Northern California Health Care Sytem
    • Connecticut
      • New Haven, Connecticut, United States, 06515
        • North Amercian Center for Limb Preservation
    • Florida
      • Miami, Florida, United States, 33125
        • University of Miami Miller School of Medicine
      • South Miami, Florida, United States, 33143
        • Doctor's Research Network
      • Tamarac, Florida, United States, 33321
        • South Florida Wound Care Group, P.A.
    • Michigan
      • Saginaw, Michigan, United States, 48602
        • Covenant Wound Healing Center
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Advanced Foot & Ankle Center
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16544
        • Saint Vincent Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Dermagraft - Allogenic Neonatal Dermal Fibroblasts Seeded on poly(glycolide-co-L-lactide)(PGLLA)Scaffold
Device: Dermagraft
Dermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum).
Active Comparator: Reference Therapy
Profore - Four-layer compression bandaging therapy
Device: Profore
Four-layer compression bandaging therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of study ulcer recurrence
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of complete study ulcer healing
Time Frame: 1 year
1 year
Incidence of study ulcer infection-related events
Time Frame: 1 year
1 year
Time to study ulcer recurrence
Time Frame: 1 year
1 year
Change in ulcer size
Time Frame: 1 year
1 year
Time to study ulcer healing
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire Regenerative Medicine, Inc.

Investigators

  • Study Director: Mollie Carter, MD, Shire Regenerative Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

June 28, 2013

First Submitted That Met QC Criteria

June 28, 2013

First Posted (Estimate)

July 3, 2013

Study Record Updates

Last Update Posted (Estimate)

August 21, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABH-Dermagraft-001-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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