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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
225

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The incidence of study ulcer recurrence
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shire Regenerative Medicine, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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