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

Primary Purpose

Venous Leg Ulcer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dermagraft(R)
Profore
Sponsored by
Organogenesis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcer focused on measuring Venous leg ulcer, randomized trial, clinical trial, Dermagraft, compression therapy, surgical debridement, venous stasis, chronic ulcer, chronic wound, fibroblasts

Eligibility Criteria

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

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

Sites / Locations

  • Coastal Clinical Research, Inc.
  • Carl T. Hayden VA Medical Center
  • HOPE Research Institute
  • Southern Arizona VA Health Care System (SAVAHCS)
  • University of Arizona College of Medicine
  • Dr. Jagpreet S. Mukker
  • VA Northern California Health Care System
  • Sutter Roseville Medical Center Wound Care Center
  • Therapeutics Clinical Research
  • General Vascular Surgery Group
  • Pacific Wound Center
  • North American Center for Limb Preservation
  • Providence Hospital
  • Foot & Ankle Associates of Florida
  • Bay Pines VA Healthcare System
  • Comprehensive Wound Healing Center
  • Osceola Regional Wound Care Center
  • University of Miami Miller School of Medicine
  • Doctor's Research Network
  • Robert Snyder, DPM, CWS
  • Aiyan Diabetes Center
  • Broadlawns Medical Center
  • Boston Medical Center, Department of Vascular Surgery
  • Beth Israel Deaconess Medical Center
  • Covenant Wound Healing Center
  • Heartland Regional Medical Center
  • Advanced Foot & Ankle Center
  • Overlook Hospital Wound Healing Program
  • Stony Brook University Medical Center
  • University of North Carolina Division of Vascular Surgery
  • Saint Vincent Health Center
  • Omega Medical Research
  • Jackson Madison County General Hospital
  • Dixie Regional Meidcal Center
  • Private Practice FA fur Dermatologie Clinical Centre
  • Private Practice / Clinical Centre
  • East-Tallinn Central Hospital
  • Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt
  • Germeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter
  • Institution DER-ART Scientific Research and Training Centre for Dermatosurgery
  • AKMed Medical Centre
  • NZOZ Clinical for Vascular Diseases
  • Malopolskie Centrum Medyczne
  • 5 Wojskowy Szpital Kliniczny w Krakowie
  • S. Zeromski Hospital Krakow
  • NZOZ "Dermed" Medical Centre (Centrum Medyczne Sp. z.o.o.)
  • Clinical Trials Centre
  • "NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology
  • "Medyk" Medical Center
  • General Surgery Clinic Autonomous Public Central Clinical Hospital (SPCSK)
  • NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wroclawskie Centrum Zdrowia)
  • Langeberg Medical Centre
  • Worthwhile Clinical Trials Lakeview Hospital
  • Edenvale Hospital, c/o CEO Secretary
  • GCT-Mercantile Clinical Trial Centre
  • Synexus SA Watermeyer Clinical Research Centre
  • Josha Research
  • Dr. D.R.Lakha, Private Practice
  • I Engelbrecht Research
  • Middelburg Hospital
  • Uncedo Clinical Research Services Mercantile Hospital
  • Cachetmed Medical Centre
  • Randles Road Medical Centre
  • Clinical Projects Research SA
  • University of Lund Dept of Dermatology
  • Overlakare/Klinikchef Hud Kliniken
  • Wound Clinic on Fairfield
  • Bradford Hospitals NHS Trust
  • Cardiff University
  • Charing Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.

Weekly application of compression dressings only, in combination with systematic surgical wound debridement.

Outcomes

Primary Outcome Measures

Complete Healing of the Study Ulcer by Week 16.

Secondary Outcome Measures

Time-to-Complete Healing
Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.

Full Information

First Posted
May 28, 2009
Last Updated
May 16, 2018
Sponsor
Organogenesis
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1. Study Identification

Unique Protocol Identification Number
NCT00909870
Brief Title
Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
Acronym
DEVO
Official Title
A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organogenesis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer
Keywords
Venous leg ulcer, randomized trial, clinical trial, Dermagraft, compression therapy, surgical debridement, venous stasis, chronic ulcer, chronic wound, fibroblasts

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
Intervention Type
Device
Intervention Name(s)
Dermagraft(R)
Intervention Description
Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.
Intervention Type
Device
Intervention Name(s)
Profore
Intervention Description
Weekly application of Profore compression dressings, in combination with systematic surgical wound debridement.
Primary Outcome Measure Information:
Title
Complete Healing of the Study Ulcer by Week 16.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Time-to-Complete Healing
Description
Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.
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.
Other Pre-specified Outcome Measures:
Title
Complete Healing by Week 16: Ulcers <= 12 Months Duration
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Marston, MD
Organizational Affiliation
University of North Carolina School of Medicine, Chapel Hill, NC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keith Harding, MD
Organizational Affiliation
Cardiff University School of Medicine, Wales, UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Bergqvist, MD
Organizational Affiliation
University of Uppsala, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coastal Clinical Research, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
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
85050
Country
United States
Facility Name
Southern Arizona VA Health Care System (SAVAHCS)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
University of Arizona College of Medicine
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Dr. Jagpreet S. Mukker
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
Facility Name
VA Northern California Health Care System
City
Mather
State/Province
California
ZIP/Postal Code
95665
Country
United States
Facility Name
Sutter Roseville Medical Center Wound Care Center
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
General Vascular Surgery Group
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Pacific Wound Center
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
North American Center for Limb Preservation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06515
Country
United States
Facility Name
Providence Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20017
Country
United States
Facility Name
Foot & Ankle Associates of Florida
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Bay Pines VA Healthcare System
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Facility Name
Comprehensive Wound Healing Center
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Osceola Regional Wound Care Center
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Doctor's Research Network
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Robert Snyder, DPM, CWS
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Aiyan Diabetes Center
City
Evans
State/Province
Georgia
ZIP/Postal Code
30809
Country
United States
Facility Name
Broadlawns Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314-1597
Country
United States
Facility Name
Boston Medical Center, Department of Vascular Surgery
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Covenant Wound Healing Center
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Advanced Foot & Ankle Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Overlook Hospital Wound Healing Program
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
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
University of North Carolina Division of Vascular Surgery
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Saint Vincent Health Center
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16544
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Jackson Madison County General Hospital
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Dixie Regional Meidcal Center
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
Private Practice FA fur Dermatologie Clinical Centre
City
Hartberg
ZIP/Postal Code
8230
Country
Austria
Facility Name
Private Practice / Clinical Centre
City
Vienna
ZIP/Postal Code
1220
Country
Austria
Facility Name
East-Tallinn Central Hospital
City
Tallinn
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
Germeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter
City
Hamburg
ZIP/Postal Code
D-22177
Country
Germany
Facility Name
Institution DER-ART Scientific Research and Training Centre for Dermatosurgery
City
Gdynia
ZIP/Postal Code
81-415
Country
Poland
Facility Name
AKMed Medical Centre
City
Krakow
ZIP/Postal Code
30-312
Country
Poland
Facility Name
NZOZ Clinical for Vascular Diseases
City
Krakow
ZIP/Postal Code
30-321
Country
Poland
Facility Name
Malopolskie Centrum Medyczne
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
5 Wojskowy Szpital Kliniczny w Krakowie
City
Krakow
ZIP/Postal Code
30-901
Country
Poland
Facility Name
S. Zeromski Hospital Krakow
City
Krakow
ZIP/Postal Code
31-913
Country
Poland
Facility Name
NZOZ "Dermed" Medical Centre (Centrum Medyczne Sp. z.o.o.)
City
Lodz
ZIP/Postal Code
90-265
Country
Poland
Facility Name
Clinical Trials Centre
City
Lublin
ZIP/Postal Code
20-022
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
"Medyk" Medical Center
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
General Surgery Clinic Autonomous Public Central Clinical Hospital (SPCSK)
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wroclawskie Centrum Zdrowia)
City
Wroclaw
ZIP/Postal Code
54-610
Country
Poland
Facility Name
Langeberg Medical Centre
City
Kraaifontein
State/Province
Cape Town
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Worthwhile Clinical Trials Lakeview Hospital
City
Benoni
State/Province
Johannesburg
ZIP/Postal Code
1500
Country
South Africa
Facility Name
Edenvale Hospital, c/o CEO Secretary
City
Edenvale
State/Province
Johhanesburg
ZIP/Postal Code
1610
Country
South Africa
Facility Name
GCT-Mercantile Clinical Trial Centre
City
Korsten
State/Province
Port Elizabeth
ZIP/Postal Code
6014
Country
South Africa
Facility Name
Synexus SA Watermeyer Clinical Research Centre
City
Meyerspark
State/Province
Pretoria
Country
South Africa
Facility Name
Josha Research
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Dr. D.R.Lakha, Private Practice
City
Johannesburg
ZIP/Postal Code
1835
Country
South Africa
Facility Name
I Engelbrecht Research
City
Lyttelton
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Middelburg Hospital
City
Middelburg
ZIP/Postal Code
1055
Country
South Africa
Facility Name
Uncedo Clinical Research Services Mercantile Hospital
City
Port Elizabeth
ZIP/Postal Code
6014
Country
South Africa
Facility Name
Cachetmed Medical Centre
City
Potchefstroom
ZIP/Postal Code
2531
Country
South Africa
Facility Name
Randles Road Medical Centre
City
Sydenham, Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Clinical Projects Research SA
City
Worcester
ZIP/Postal Code
6850
Country
South Africa
Facility Name
University of Lund Dept of Dermatology
City
Lund
Country
Sweden
Facility Name
Overlakare/Klinikchef Hud Kliniken
City
Stockholm
ZIP/Postal Code
SE-118 83
Country
Sweden
Facility Name
Wound Clinic on Fairfield
City
Croydon
State/Province
Surrey
ZIP/Postal Code
CR7 7YE
Country
United Kingdom
Facility Name
Bradford Hospitals NHS Trust
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Cardiff University
City
Cardiff
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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