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

NCT00387101 | Terminated Phase 3

• 1 other identifier: RS03-2004
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 12

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.

Conditions

Diabetic Foot Ulcer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Dermal - Living Skin Replacement (Dermal - LSR) DEVICE

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ApoPharma: lead

Study Sites (12)

Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112)

Tuscon, Arizona, 85723, United States

Location

Veterans Affairs Northern Health Care System, Sacramento VA Medical Center at Mather

Mather, California, 95655, United States

Location

San Diego Research Center 4452 Park Boulevard Suite 210, San Diego

San Diego, California, 92116, United States

Location

Doctors Research Network

South Miami, Florida, 33143, United States

Location

Weil Foot and Ankle Institute

Des Plaines, Illinois, 60016, United States

Location

Hines VA Hospital

Hines, Illinois, 60141, United States

Location

National Center for Lower Limb Preservation

Niles, Illinois, 60714, United States

Location

Foot Care Vascular and Endovascular Specialists of Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Joslin-Beth Israel Deaconess Foot Center, Division of Podiatry, 185 Pilgrim Road

Boston, Massachusetts, 02215, United States

Location

North Shore Diabetic and Endocrine Associates

New Hyde Park, New York, 11042, United States

Location

The Learner Research Centre, Department of Orthopaedic Surgery. The Cleveland Clinic Foundation, 9500 Euclid Ave. A40

Cleveland, Ohio, 44195, United States

Location

Center for Advanced Wound Care

Reading, Pennsylvania, 19601, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 12, 2006
• Study Start: February 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: April 1, 2008
• Last Updated: May 2, 2008

Record last verified: 2008-04

Locations

US (12)