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

NCT00909870 | Completed Phase 3 Results

• 1 other identifier: ABH-Dermagraft-001-08
• Study Type: interventional
• Target: 537
• Locations: 8 countries
• Sites: 70

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.

Conditions

Venous Leg Ulcer

Keywords

Venous leg ulcer; randomized trial; clinical trial; Dermagraft; compression therapy; surgical debridement; venous stasis; chronic ulcer; chronic wound; fibroblasts

Outcome Measures

Primary Outcomes (1)

• Complete Healing of the Study Ulcer by Week 16.

  16 weeks

Secondary Outcomes (1)

• Time-to-Complete Healing

  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 Outcomes (1)

• Complete Healing by Week 16: Ulcers <= 12 Months Duration

  16 weeks

Study Arms (2)

1

EXPERIMENTAL

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

Device: Dermagraft(R)

2

ACTIVE COMPARATOR

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

Device: Profore

Interventions

Dermagraft(R) DEVICE

Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.

1

Profore DEVICE

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Organogenesis: lead

Study Sites (70)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

Carl T. Hayden VA Medical Center

Phoenix, Arizona, 85012, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85050, United States

Location

Southern Arizona VA Health Care System (SAVAHCS)

Tucson, Arizona, 85723, United States

Location

University of Arizona College of Medicine

Tucson, Arizona, 85724, United States

Location

Dr. Jagpreet S. Mukker

Fresno, California, 93726, United States

Location

VA Northern California Health Care System

Mather, California, 95665, United States

Location

Sutter Roseville Medical Center Wound Care Center

Roseville, California, 95661, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

General Vascular Surgery Group

San Leandro, California, 94578, United States

Location

Pacific Wound Center

Stockton, California, 95204, United States

Location

North American Center for Limb Preservation

New Haven, Connecticut, 06515, United States

Location

Providence Hospital

Washington D.C., District of Columbia, 20017, United States

Location

Foot & Ankle Associates of Florida

Altamonte Springs, Florida, 32701, United States

Location

Bay Pines VA Healthcare System

Bay Pines, Florida, 33744, United States

Location

Comprehensive Wound Healing Center

Clearwater, Florida, 33756, United States

Location

Osceola Regional Wound Care Center

Kissimmee, Florida, 34741, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Doctor's Research Network

South Miami, Florida, 33143, United States

Location

Robert Snyder, DPM, CWS

Tamarac, Florida, 33321, United States

Location

Aiyan Diabetes Center

Evans, Georgia, 30809, United States

Location

Broadlawns Medical Center

Des Moines, Iowa, 50314-1597, United States

Location

Boston Medical Center, Department of Vascular Surgery

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Covenant Wound Healing Center

Saginaw, Michigan, 48602, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

Location

Advanced Foot & Ankle Center

Las Vegas, Nevada, 89119, United States

Location

Overlook Hospital Wound Healing Program

Summit, New Jersey, 07901, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

University of North Carolina Division of Vascular Surgery

Chapel Hill, North Carolina, 27599, United States

Location

Saint Vincent Health Center

Erie, Pennsylvania, 16544, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Jackson Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

Dixie Regional Meidcal Center

St. George, Utah, 84770, United States

Location

Private Practice FA fur Dermatologie Clinical Centre

Hartberg, 8230, Austria

Location

Private Practice / Clinical Centre

Vienna, 1220, Austria

Location

East-Tallinn Central Hospital

Tallinn, 11312, Estonia

Location

Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt

Freiburg im Breisgau, D-79100, Germany

Location

Germeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter

Hamburg, D-22177, Germany

Location

Institution DER-ART Scientific Research and Training Centre for Dermatosurgery

Gdynia, 81-415, Poland

Location

AKMed Medical Centre

Krakow, 30-312, Poland

Location

NZOZ Clinical for Vascular Diseases

Krakow, 30-321, Poland

Location

Malopolskie Centrum Medyczne

Krakow, 30-510, Poland

Location

5 Wojskowy Szpital Kliniczny w Krakowie

Krakow, 30-901, Poland

Location

S. Zeromski Hospital Krakow

Krakow, 31-913, Poland

Location

NZOZ "Dermed" Medical Centre (Centrum Medyczne Sp. z.o.o.)

Lodz, 90-265, Poland

Location

Clinical Trials Centre

Lublin, 20-022, Poland

Location

"NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology

Nowy Sącz, 33-300, Poland

Location

"Medyk" Medical Center

Rzeszów, 35-055, Poland

Location

General Surgery Clinic Autonomous Public Central Clinical Hospital (SPCSK)

Warsaw, 02-097, Poland

Location

NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wroclawskie Centrum Zdrowia)

Wroclaw, 54-610, Poland

Location

Langeberg Medical Centre

Kraaifontein, Cape Town, 7570, South Africa

Location

Worthwhile Clinical Trials Lakeview Hospital

Benoni, Johannesburg, 1500, South Africa

Location

Edenvale Hospital, c/o CEO Secretary

Edenvale, Johhanesburg, 1610, South Africa

Location

GCT-Mercantile Clinical Trial Centre

Korsten, Port Elizabeth, 6014, South Africa

Location

Synexus SA Watermeyer Clinical Research Centre

Meyerspark, Pretoria, South Africa

Location

Josha Research

Bloemfontein, 9301, South Africa

Location

Dr. D.R.Lakha, Private Practice

Johannesburg, 1835, South Africa

Location

I Engelbrecht Research

Lyttelton, 0157, South Africa

Location

Middelburg Hospital

Middelburg, 1055, South Africa

Location

Uncedo Clinical Research Services Mercantile Hospital

Port Elizabeth, 6014, South Africa

Location

Cachetmed Medical Centre

Potchefstroom, 2531, South Africa

Location

Randles Road Medical Centre

Sydenham, Durban, 4091, South Africa

Location

Clinical Projects Research SA

Worcester, 6850, South Africa

Location

University of Lund Dept of Dermatology

Lund, Sweden

Location

Overlakare/Klinikchef Hud Kliniken

Stockholm, SE-118 83, Sweden

Location

Wound Clinic on Fairfield

Croydon, Surrey, CR7 7YE, United Kingdom

Location

Bradford Hospitals NHS Trust

Bradford, BD9 6RJ, United Kingdom

Location

Cardiff University

Cardiff, CF14 4XN, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Mollie Carter, MD, Medical Director
• Organization: Shire Regenerative Medicine

mcarter@shire.com

(858) 754-5678

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: May 29, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 18, 2018
• Results First Posted: February 4, 2013

Record last verified: 2018-05

Locations

ES (1); AU (2); PL (12); ZA (13); SE (2); GB (4); DE (2); US (34)