Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers

Sponsor

ApoPharma (Industry)

Overall Status

Terminated

CT.gov ID

NCT00387101

Collaborator

(none)

288

Enrollment

Locations

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcer	Device: Dermal - Living Skin Replacement (Dermal - LSR)	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

288 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Feb 1, 2006

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Apr 1, 2008

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 84 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112)	Tuscon	Arizona	United States	85723
2	Veterans Affairs Northern Health Care System, Sacramento VA Medical Center at Mather	Mather	California	United States	95655
3	San Diego Research Center 4452 Park Boulevard Suite 210, San Diego	San Diego	California	United States	92116
4	Doctors Research Network	South Miami	Florida	United States	33143
5	Weil Foot and Ankle Institute	Des Plaines	Illinois	United States	60016
6	Hines VA Hospital	Hines	Illinois	United States	60141
7	National Center for Lower Limb Preservation	Niles	Illinois	United States	60714
8	Foot Care Vascular and Endovascular Specialists of Boston Medical Center	Boston	Massachusetts	United States	02118
9	Joslin-Beth Israel Deaconess Foot Center, Division of Podiatry, 185 Pilgrim Road	Boston	Massachusetts	United States	02215
10	North Shore Diabetic and Endocrine Associates	New Hyde Park	New York	United States	11042
11	The Learner Research Centre, Department of Orthopaedic Surgery. The Cleveland Clinic Foundation, 9500 Euclid Ave. A40	Cleveland	Ohio	United States	44195
12	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