Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers - Full Text View

Sponsor:	ApoPharma
Information provided by:	ApoPharma
ClinicalTrials.gov Identifier:	NCT00387101

Purpose

The purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone.

Condition	Intervention	Phase
Diabetic Foot Ulcer	Device: Dermal - Living Skin Replacement (Dermal - LSR)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pivotal Study to Evaluate the Efficacy and Safety of Dermal-Living Skin Replacement (Dermal-LSR) in the Treatment of Chronic Diabetic Foot Ulcers

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Foot Foot Health

U.S. FDA Resources

Further study details as provided by ApoPharma:

Primary Outcome Measures:

To determine the efficacy and safety of Dermal-LSR plus Standard of Care (SOC) for the treatment of chronic diabetic foot ulcers in comparison to treatment with SOC alone.

Estimated Enrollment:	288
Study Start Date:	February 2006
Study Completion Date:	April 2008
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Detailed Description:

The study is a pivotal, prospective, randomized, controlled, open-label, multi-center study that will evaluate the effectiveness and safety of topically applied Dermal-LSR in chronic DFUs.

Eligibility

Ages Eligible for Study:	18 Years to 84 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Has signed a written informed consent prior to the first study intervention
Is at least 18 and <85 years of age
Has one or more diabetic foot ulcers on the target limb, with only one marked for the study (target ulcer). It must have the following characteristics:Plantar; Grade 2 per Curative Health Services Classification; Non-infected; Neuropathic; Non-malignant; At least 1.0-25cm^2 post-debridement; Present for at least 6 weeks
Has Type I or II Diabetes Mellitus with an HBA1c between 6-10%
Has a maximum fasting blood glucose level of 13.8 mmol/L
An ankle-brachial systolic pressure index between 0.7 and 1.3
If female and of childbearing potential has a negative serum pregnancy test and is neither breastfeeding or intending to become pregnant during the study
Able and willing to attend the scheduled visits and comply with study procedures.

Exclusion Criteria:

Known or suspected disease of the immune system
Active or untreated malignancy or active, uncontrolled connective tissue disease
Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment
Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement
Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to enrollment
Active febrile illness
AST, ALT, ALP >3x the normal upper limit
Serum Creatinine >2x the normal upper limit
Osteomyelitis
Active Charcot
Use of any topical treatments other than SOC (standard of care)at the time of enrollment
Enrollment in any investigational clinical trial within 30 days of the screening visit
Known or suspected hypersensitivity to any study product components
Recent or current history of alcohol or drug abuse
Any condition, which in the opinion of the Investigator, would interfere with the evaluation of the study product or poses a health risk to the subject
All site personnel directly affiliated with this study and their immediate families

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387101

Locations

United States, Arizona
Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112)
Tuscon, Arizona, United States, 85723
United States, California
Veterans Affairs Northern Health Care System, Sacramento VA Medical Center at Mather
Mather, California, United States, 95655
San Diego Research Center 4452 Park Boulevard Suite 210, San Diego
San Diego, California, United States, 92116
United States, Florida
Doctors Research Network
South Miami, Florida, United States, 33143
United States, Illinois
Weil Foot and Ankle Institute
Des Plaines, Illinois, United States, 60016
Hines VA Hospital
Hines, Illinois, United States, 60141
National Center for Lower Limb Preservation
Niles, Illinois, United States, 60714
United States, Massachusetts
Foot Care Vascular and Endovascular Specialists of Boston Medical Center
Boston, Massachusetts, United States, 02118
Joslin-Beth Israel Deaconess Foot Center, Division of Podiatry, 185 Pilgrim Road
Boston, Massachusetts, United States, 02215
United States, New York
North Shore Diabetic and Endocrine Associates
New Hyde Park, New York, United States, 11042
United States, Ohio
The Learner Research Centre, Department of Orthopaedic Surgery. The Cleveland Clinic Foundation, 9500 Euclid Ave. A40
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Center for Advanced Wound Care
Reading, Pennsylvania, United States, 19601

Sponsors and Collaborators

ApoPharma

Investigators

Principal Investigator:	Jason R Hanft, DPM, FAC FAS	Doctors Research Network, 7000 SW 62nd Avenue, Suite 310, South Miami, FL 33143
Principal Investigator:	Hau Pham, DPM	Foot Care Vascular and Endovascular Specialists of Boston Medical Center, 732 Harrison Ave., 2nd Floor, Boston, MA 02118
Principal Investigator:	Rodney Stuck, DPM	Hines VA Hospital, 5th and Roosevelt Rd., Building 200, 5th Floor, Room 501, Hines, IL 60141
Principal Investigator:	Vickie Driver, DPM	National Center for Lower Limb Preservation, 8816 Dempster Street, Niles, Il 60714
Principal Investigator:	Zevi Isseroff, DPM	North Shore Diabetic and Endocrine Associates, 3003 New Hyde Park Road Suite 201, New Hyde Park, NY, 11042
Principal Investigator:	Lowell Weil, Jr., DPM, MBA, FAC FAS	Weil Foot and Ankle Institute, 1455 Golf Rd., Suite 110, Golf-River Professional Building, Des Plaines, IL 60016
Principal Investigator:	Michal Drews	SPSK nr 2 im. H. Święcickiego AM Oddział Kliniczny Chirurgii Ogólnej Gastroenterologicznej i Endokrynologicznej ul. Przybyszewskiego 49
Principal Investigator:	Henryk Komon	Centrum Medyczno-Diagnostyczne Sp. z o.o. ul. Piłsudskiego 49 08-110 Siedlce Poland
Principal Investigator:	Krystyna Pilarska	SPWSZ w Szczecinie Klinika Endokrynologii, NadciśnieniaTętniczego i Chorób Przemiany Materii PAM ul. Arkońska 4 71-455 Szczecin
Principal Investigator:	Malgorzata Wilczynska	NZOZ Centrum Opieki Diabetologiczno-Endokrynologicznej ul. Karola Miarki 6 50-306 Wrocław Poland
Principal Investigator:	Joseph Cavorsi, M.D.	Center for Advanced Wound Care 640 Walnut St., Suite 302 Reading, PA 19601
Principal Investigator:	Roslyn R Isseroff, M.D.	Veterans Affairs Northern Health Care System
Principal Investigator:	Georgeanne Botek, DPM	The Learner Research Centre, Department of Orthopaedic Surgery. The Cleveland Clinic Foundation, 9500 Euclid Ave. A40, Cleveland, OH 44195,
Principal Investigator:	Adam Landsman, DPM, PhD	Joslin-Beth Israel Deaconess Foot Center, Division of Podiatry, 185 Pilgrim Road, Boston, MA 02215
Principal Investigator:	Jodi Walters, DPM	Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112), Tucson, AZ 85723
Principal Investigator:	Martin Taubman, DPM	San Diego Research Center 4452 Park Boulevard Suite 210, San Diego, CA 92116

More Information

No publications provided

Study ID Numbers:	RS03-2004
Study First Received:	October 10, 2006
Last Updated:	April 30, 2008
ClinicalTrials.gov Identifier:	NCT00387101 History of Changes
Health Authority:	United States: Food and Drug Administration; European Union: European Medicines Agency; Canada: Health Canada

Keywords provided by ApoPharma:

Diabetic Foot Ulcer
Diabetes Mellitus
Debridement
Dermal-LSR
Standard of Care

Additional relevant MeSH terms:

Foot Ulcer
Diabetic Neuropathies
Skin Diseases
Ulcer
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Foot Diseases

Diabetic Angiopathies
Pathologic Processes
Cardiovascular Diseases
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

ClinicalTrials.gov processed this record on November 27, 2009