Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers (DEVO)

May 16, 2018 updated by: Organogenesis

A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial

This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 16-week treatment period is complete. Follow-up visits are conducted monthly for three months in order to assess patients for longer term safety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

537

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

  • Austria
      • Hartberg, Austria, 8230
        • Private Practice FA fur Dermatologie Clinical Centre
      • Vienna, Austria, 1220
        • Private Practice / Clinical Centre
  • Estonia
      • Tallinn, Estonia, 11312
        • East-Tallinn Central Hospital
  • Germany
      • Freiburg, Germany, D-79100
        • Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt
      • Hamburg, Germany, D-22177
        • Germeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter
  • Poland
      • Gdynia, Poland, 81-415
        • Institution DER-ART Scientific Research and Training Centre for Dermatosurgery
      • Krakow, Poland, 30-510
        • Malopolskie Centrum Medyczne
      • Krakow, Poland, 30-312
        • AKMed Medical Centre
      • Krakow, Poland, 30-321
        • NZOZ Clinical for Vascular Diseases
      • Krakow, Poland, 30-901
        • 5 Wojskowy Szpital Kliniczny w Krakowie
      • Krakow, Poland, 31-913
        • S. Zeromski Hospital Krakow
      • Lodz, Poland, 90-265
        • NZOZ "Dermed" Medical Centre (Centrum Medyczne Sp. z.o.o.)
      • Lublin, Poland, 20-022
        • Clinical Trials Centre
      • Nowy Sacz, Poland, 33-300
        • "NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology
      • Rzeszow, Poland, 35-055
        • "Medyk" Medical Center
      • Warszawa, Poland, 02-097
        • General Surgery Clinic Autonomous Public Central Clinical Hospital (SPCSK)
      • Wroclaw, Poland, 54-610
        • NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wroclawskie Centrum Zdrowia)
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Josha Research
      • Johannesburg, South Africa, 1835
        • Dr. D.R.Lakha, Private Practice
      • Lyttelton, South Africa, 0157
        • I Engelbrecht Research
      • Middelburg, South Africa, 1055
        • Middelburg Hospital
      • Port Elizabeth, South Africa, 6014
        • Uncedo Clinical Research Services Mercantile Hospital
      • Potchefstroom, South Africa, 2531
        • Cachetmed Medical Centre
      • Sydenham, Durban, South Africa, 4091
        • Randles Road Medical Centre
      • Worcester, South Africa, 6850
        • Clinical Projects Research SA
    • Cape Town
      • Kraaifontein, Cape Town, South Africa, 7570
        • Langeberg Medical Centre
    • Johannesburg
      • Benoni, Johannesburg, South Africa, 1500
        • Worthwhile Clinical Trials Lakeview Hospital
    • Johhanesburg
      • Edenvale, Johhanesburg, South Africa, 1610
        • Edenvale Hospital, c/o CEO Secretary
    • Port Elizabeth
      • Korsten, Port Elizabeth, South Africa, 6014
        • GCT-Mercantile Clinical Trial Centre
    • Pretoria
      • Meyerspark, Pretoria, South Africa
        • Synexus SA Watermeyer Clinical Research Centre
  • Sweden
      • Lund, Sweden
        • University of Lund Dept of Dermatology
      • Stockholm, Sweden, SE-118 83
        • Overlakare/Klinikchef Hud Kliniken
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Hospitals NHS Trust
      • Cardiff, United Kingdom, CF14 4XN
        • Cardiff University
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital
    • Surrey
      • Croydon, Surrey, United Kingdom, CR7 7YE
        • Wound Clinic on Fairfield
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research, Inc.
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • HOPE Research Institute
      • Phoenix, Arizona, United States, 85012
        • Carl T. Hayden VA Medical Center
      • Tucson, Arizona, United States, 85724
        • University of Arizona College of Medicine
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Health Care System (SAVAHCS)
    • California
      • Fresno, California, United States, 93726
        • Dr. Jagpreet S. Mukker
      • Mather, California, United States, 95665
        • VA Northern California Health Care System
      • Roseville, California, United States, 95661
        • Sutter Roseville Medical Center Wound Care Center
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research
      • San Leandro, California, United States, 94578
        • General Vascular Surgery Group
      • Stockton, California, United States, 95204
        • Pacific Wound Center
    • Connecticut
      • New Haven, Connecticut, United States, 06515
        • North American Center for Limb Preservation
    • District of Columbia
      • Washington, District of Columbia, United States, 20017
        • Providence Hospital
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Foot & Ankle Associates of Florida
      • Bay Pines, Florida, United States, 33744
        • Bay Pines VA Healthcare System
      • Clearwater, Florida, United States, 33756
        • Comprehensive Wound Healing Center
      • Kissimmee, Florida, United States, 34741
        • Osceola Regional Wound Care Center
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
      • South Miami, Florida, United States, 33143
        • Doctor's Research Network
      • Tamarac, Florida, United States, 33321
        • Robert Snyder, DPM, CWS
    • Georgia
      • Evans, Georgia, United States, 30809
        • Aiyan Diabetes Center
    • Iowa
      • Des Moines, Iowa, United States, 50314-1597
        • Broadlawns Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center, Department of Vascular Surgery
    • Michigan
      • Saginaw, Michigan, United States, 48602
        • Covenant Wound Healing Center
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Advanced Foot & Ankle Center
    • New Jersey
      • Summit, New Jersey, United States, 07901
        • Overlook Hospital Wound Healing Program
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Division of Vascular Surgery
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16544
        • Saint Vincent Health Center
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • Jackson Madison County General Hospital
    • Utah
      • Saint George, Utah, United States, 84770
        • Dixie Regional Meidcal 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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >18 years of age
  • ABI > 0.80
  • Three or fewer venous leg ulcers, if multiple must be separated by 2 cm
  • Ultrasound demonstrates venous reflux >0.5 seconds
  • Study wound present for 1-24 months
  • Study wound 2-15 sq cm surface area
  • Clean, granulating wound
  • Patient able and willing to sign informed consent and comply with study procedures.
  • Women of childbearing potential must use birth control pills, barriers or abstinence and have a negative pregnancy test.

Exclusion Criteria:

  • Wound etiology uncertain or not from venous hypertension.
  • BMI>40
  • Acute or chronic infectious skin disease
  • Allergy or intolerance to Profore(R)
  • Wound infection, cellulitis, osteomyelitis
  • >2 weeks' treatment with immunosuppressive agents in recent past
  • Investigational drug use within 30 days
  • Severe malnutrition, drug and/or alcohol abuse
  • Malignant disease unless in remission for 5 years
  • History of radiation at the study site
  • Other conditions that could impede wound healing
  • Known history of HIV or AIDS
  • Prior participation in any Dermagraft study
  • Treatment with other bioengineered tissue products within 30 days
  • Unable to understand the aims and objectives of the trial
  • Inability to comply with study protocol
  • NYHA Class III or IV CHF
  • Uncontrolled diabetes mellitus
  • Dorsal foot ulcer

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
Device: Dermagraft(R)
Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.
Active Comparator: 2
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
Device: Profore
Weekly application of Profore compression dressings, in combination with systematic surgical wound debridement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete Healing of the Study Ulcer by Week 16.
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-to-Complete Healing
Time Frame: From Week 0 visit to date subject's completely healed ulcer is 1st recorded as healed. If subject's ulcer not healed at 16 weeks, the "time until CH" was censored at 112 days.
Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.
From Week 0 visit to date subject's completely healed ulcer is 1st recorded as healed. If subject's ulcer not healed at 16 weeks, the "time until CH" was censored at 112 days.

Other Outcome Measures

Outcome Measure
Time Frame
Complete Healing by Week 16: Ulcers <= 12 Months Duration
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

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

Sponsor

Organogenesis

Investigators

  • Principal Investigator: William Marston, MD, University of North Carolina School of Medicine, Chapel Hill, NC
  • Principal Investigator: Keith Harding, MD, Cardiff University School of Medicine, Wales, UK
  • Principal Investigator: David Bergqvist, MD, University of Uppsala, Sweden

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

June 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

May 28, 2009

First Posted (Estimate)

May 29, 2009

Study Record Updates

Last Update Posted (Actual)

June 18, 2018

Last Update Submitted That Met QC Criteria

May 16, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABH-Dermagraft-001-08

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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