Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers
NCT ID: NCT00387101
Last Updated: 2008-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
288 participants
INTERVENTIONAL
2006-02-28
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Dermal - Living Skin Replacement (Dermal - LSR)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
84 Years
ALL
No
Sponsors
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ApoPharma
INDUSTRY
Principal Investigators
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Jason R Hanft, DPM, FAC FAS
Role: PRINCIPAL_INVESTIGATOR
Doctors Research Network, 7000 SW 62nd Avenue, Suite 310, South Miami, FL 33143
Hau Pham, DPM
Role: PRINCIPAL_INVESTIGATOR
Foot Care Vascular and Endovascular Specialists of Boston Medical Center, 732 Harrison Ave., 2nd Floor, Boston, MA 02118
Rodney Stuck, DPM
Role: PRINCIPAL_INVESTIGATOR
Hines VA Hospital, 5th and Roosevelt Rd., Building 200, 5th Floor, Room 501, Hines, IL 60141
Vickie Driver, DPM
Role: PRINCIPAL_INVESTIGATOR
National Center for Lower Limb Preservation, 8816 Dempster Street, Niles, Il 60714
Zevi Isseroff, DPM
Role: PRINCIPAL_INVESTIGATOR
North Shore Diabetic and Endocrine Associates, 3003 New Hyde Park Road Suite 201, New Hyde Park, NY, 11042
Lowell Weil, Jr., DPM, MBA, FAC FAS
Role: PRINCIPAL_INVESTIGATOR
Weil Foot and Ankle Institute, 1455 Golf Rd., Suite 110, Golf-River Professional Building, Des Plaines, IL 60016
Michal Drews
Role: PRINCIPAL_INVESTIGATOR
SPSK nr 2 im. H. Święcickiego AM Oddział Kliniczny Chirurgii Ogólnej Gastroenterologicznej i Endokrynologicznej ul. Przybyszewskiego 49
Henryk Komon
Role: PRINCIPAL_INVESTIGATOR
Centrum Medyczno-Diagnostyczne Sp. z o.o. ul. Piłsudskiego 49 08-110 Siedlce Poland
Krystyna Pilarska
Role: PRINCIPAL_INVESTIGATOR
SPWSZ w Szczecinie Klinika Endokrynologii, NadciśnieniaTętniczego i Chorób Przemiany Materii PAM ul. Arkońska 4 71-455 Szczecin
Malgorzata Wilczynska
Role: PRINCIPAL_INVESTIGATOR
NZOZ Centrum Opieki Diabetologiczno-Endokrynologicznej ul. Karola Miarki 6 50-306 Wrocław Poland
Joseph Cavorsi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Center for Advanced Wound Care 640 Walnut St., Suite 302 Reading, PA 19601
Roslyn R Isseroff, M.D.
Role: PRINCIPAL_INVESTIGATOR
Veterans Affairs Northern Health Care System
Georgeanne Botek, DPM
Role: PRINCIPAL_INVESTIGATOR
The Learner Research Centre, Department of Orthopaedic Surgery. The Cleveland Clinic Foundation, 9500 Euclid Ave. A40, Cleveland, OH 44195,
Adam Landsman, DPM, PhD
Role: PRINCIPAL_INVESTIGATOR
Joslin-Beth Israel Deaconess Foot Center, Division of Podiatry, 185 Pilgrim Road, Boston, MA 02215
Jodi Walters, DPM
Role: PRINCIPAL_INVESTIGATOR
Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112), Tucson, AZ 85723
Martin Taubman, DPM
Role: PRINCIPAL_INVESTIGATOR
San Diego Research Center 4452 Park Boulevard Suite 210, San Diego, CA 92116
Locations
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Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112)
Tuscon, Arizona, United States
Veterans Affairs Northern Health Care System, Sacramento VA Medical Center at Mather
Mather, California, United States
San Diego Research Center 4452 Park Boulevard Suite 210, San Diego
San Diego, California, United States
Doctors Research Network
South Miami, Florida, United States
Weil Foot and Ankle Institute
Des Plaines, Illinois, United States
Hines VA Hospital
Hines, Illinois, United States
National Center for Lower Limb Preservation
Niles, Illinois, United States
Foot Care Vascular and Endovascular Specialists of Boston Medical Center
Boston, Massachusetts, United States
Joslin-Beth Israel Deaconess Foot Center, Division of Podiatry, 185 Pilgrim Road
Boston, Massachusetts, United States
North Shore Diabetic and Endocrine Associates
New Hyde Park, New York, United States
The Learner Research Centre, Department of Orthopaedic Surgery. The Cleveland Clinic Foundation, 9500 Euclid Ave. A40
Cleveland, Ohio, United States
Center for Advanced Wound Care
Reading, Pennsylvania, United States
Countries
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Other Identifiers
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RS03-2004
Identifier Type: -
Identifier Source: org_study_id