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

PHASE3CompletedINTERVENTIONAL
Enrollment

537

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

May 31, 2011

Study Completion Date

August 31, 2011

Conditions
Venous Leg Ulcer
Interventions
DEVICE

Dermagraft(R)

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

DEVICE

Profore

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

Trial Locations (70)

1055

Middelburg Hospital, Middelburg

1220

Private Practice / Clinical Centre, Vienna

1500

Worthwhile Clinical Trials Lakeview Hospital, Benoni

1610

Edenvale Hospital, c/o CEO Secretary, Edenvale

1835

Dr. D.R.Lakha, Private Practice, Johannesburg

2531

Cachetmed Medical Centre, Potchefstroom

4091

Randles Road Medical Centre, Sydenham, Durban

6014

GCT-Mercantile Clinical Trial Centre, Korsten

Uncedo Clinical Research Services Mercantile Hospital, Port Elizabeth

6850

Clinical Projects Research SA, Worcester

7570

Langeberg Medical Centre, Kraaifontein

8230

Private Practice FA fur Dermatologie Clinical Centre, Hartberg

9301

Josha Research, Bloemfontein

11312

East-Tallinn Central Hospital, Tallinn

11794

Stony Brook University Medical Center, Stony Brook

16544

Saint Vincent Health Center, Erie

20017

Providence Hospital, Washington D.C.

27599

University of North Carolina Division of Vascular Surgery, Chapel Hill

30809

Aiyan Diabetes Center, Evans

32701

Foot & Ankle Associates of Florida, Altamonte Springs

33136

University of Miami Miller School of Medicine, Miami

33143

Doctor's Research Network, South Miami

33321

Robert Snyder, DPM, CWS, Tamarac

33744

Bay Pines VA Healthcare System, Bay Pines

33756

Comprehensive Wound Healing Center, Clearwater

34741

Osceola Regional Wound Care Center, Kissimmee

36608

Coastal Clinical Research, Inc., Mobile

38301

Jackson Madison County General Hospital, Jackson

48602

Covenant Wound Healing Center, Saginaw

64506

Heartland Regional Medical Center, Saint Joseph

84770

Dixie Regional Meidcal Center, St. George

85012

Carl T. Hayden VA Medical Center, Phoenix

85050

HOPE Research Institute, Phoenix

85723

Southern Arizona VA Health Care System (SAVAHCS), Tucson

85724

University of Arizona College of Medicine, Tucson

89119

Advanced Foot & Ankle Center, Las Vegas

92123

Therapeutics Clinical Research, San Diego

93726

Dr. Jagpreet S. Mukker, Fresno

94578

General Vascular Surgery Group, San Leandro

95204

Pacific Wound Center, Stockton

95661

Sutter Roseville Medical Center Wound Care Center, Roseville

95665

VA Northern California Health Care System, Mather

06515

North American Center for Limb Preservation, New Haven

50314-1597

Broadlawns Medical Center, Des Moines

02118

Boston Medical Center, Department of Vascular Surgery, Boston

02215

Beth Israel Deaconess Medical Center, Boston

07901

Overlook Hospital Wound Healing Program, Summit

02886

Omega Medical Research, Warwick

D-79100

Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt, Freiburg im Breisgau

D-22177

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

81-415

Institution DER-ART Scientific Research and Training Centre for Dermatosurgery, Gdynia

30-312

AKMed Medical Centre, Krakow

30-321

NZOZ Clinical for Vascular Diseases, Krakow

30-510

Malopolskie Centrum Medyczne, Krakow

30-901

5 Wojskowy Szpital Kliniczny w Krakowie, Krakow

31-913

S. Zeromski Hospital Krakow, Krakow

90-265

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

20-022

Clinical Trials Centre, Lublin

33-300

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

35-055

"Medyk Medical Center", Rzeszów

02-097

General Surgery Clinic Autonomous Public Central Clinical Hospital (SPCSK), Warsaw

54-610

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

Unknown

Synexus SA Watermeyer Clinical Research Centre, Meyerspark

University of Lund Dept of Dermatology, Lund

0157

I Engelbrecht Research, Lyttelton

SE-118 83

Overlakare/Klinikchef Hud Kliniken, Stockholm

CR7 7YE

Wound Clinic on Fairfield, Croydon

BD9 6RJ

Bradford Hospitals NHS Trust, Bradford

CF14 4XN

Cardiff University, Cardiff

W6 8RF

Charing Cross Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Organogenesis

INDUSTRY

NCT00909870 - Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers | Biotech Hunter | Biotech Hunter