Matrix Clinical Study

MATRIX Clinical Study

Purpose
The Phase 2b MATRIX trial will study the effects of Excellarate™ (GAM501) (Ad5PDGF-B/bovine Type I collagen gel) in men and women for the potential treatment of neuropathic non-healing diabetic foot ulcers. GAM501 is an investigational product designed to stimulate the process of wound healing.

Study Title
MATRIX: A Phase 2b Study of GAM501 in the Treatment of Diabetic Ulcers in the Lower Extremities

Study Design: The MATRIX study is a randomized, double-blind, placebo-controlled, comparator arm (Standard of Care) safety and efficacy study to evaluate GAM501 (Ad5PDGF-B/bovine type I collagen gel) that is topically administered once or twice.

Primary and Secondary Endpoints: The primary endpoint will be the effect of GAM501 on the incidence of complete ulcer closure at 12 weeks or earlier. The secondary endpoints will include other measures of wound healing.

Eligibility

Male and female patients 18 years of age and above with a lower extremity ulcer of the foot that is ≥1.5 and ≤10.0 cm² in size.
Patients must have a diagnosis of diabetes mellitus (Type I or II) requiring insulin or hypoglycemic agents to control blood sugars,
The patient’s ulcer must have been present for ≥6 weeks prior to enrollment, must have adequate blood flow to the affected foot and be unable to perceive 10 grams of pressure, and
Willing to adhere to wearing off-loading orthopedic shoe for up to 16 weeks

Contact Information
For additional information about the MATRIX clinical study and enrollment information please visit http://clinicaltrials.gov/ct/show/NCT00493051 or call Tissue Repair Company at 858-793-6641.

MATRIX Study Website

Clinical Study Locations

United States, Alabama

Baptist Medical Center South
Not yet recruiting
Montgomery, Alabama, United States, 36111
Contact: Ruth Russell 334-286-3444 russ1620@bellsouth.net
Principal Investigator: Terry Treadwell, MD

United States, Arizona

Aung Foothealth Clinics
Recruiting
Tuscon, Arizona, United States, 85710
Contact: Chuck Heidenreich draung@theriver.com
Principal Investigator: Barbara Aung, DPM

Banner Baywood Medical Center
Recruiting
Mesa, Arizona, United States, 85206
Contact: Barbara Lambeth, RN barbara.lambeth@bannerhealth.com
Principal Investigator: Mark Starling, MD

Associated Foot & Ankle Specialists
Recruiting
Phoenix, Arizona, United States, 85015
Contact: Norma Ramos sugie2468@netzero.net
Principal Investigator: Arthur Tallis, DPM

United States, Arkansas

St. Vincent Wound Center
Not yet recruiting
Little Rock, Arkansas, United States, 72205
Contact: CB Goins 510-681-2668 cbgoins@swbell.net
Principal Investigator: Leslie Sessions, MD

United States, California

LAC-USC Medical Center
Recruiting
Los Angeles, California, United States, 90033
Contact: Javona Wright jwright@surgery.usc.edu
Principal Investigator: Warren Garner, MD

Dr. Roy Kroeker DPM
Recruiting
Fresno, California, United States, 93710
Contact: Mary Kroeker mem-k@pacbell.net
Principal Investigator: Roy Kroeker, DPM

Long Beach VA Health Care System
Recruiting
Long Beach, California, United States, 90822
Contact: Kay Crosser 562-826-8190 kay.crosser@va.gov
Contact: Reza Azadegan 562 826 8000 ext 2887 reza.azadegan@va.gov
Principal Investigator: Ian Gordon, MD

Foot Doctors of Watsonville
Recruiting
Watsonville, California, United States, 95076
Contact: Juan Gutierrez 831-728-8844 juanlg82@sbcglobal.net
Principal Investigator: David Abdoo, DPM

Absolute Foot Care
Not yet recruiting
Chula Vista, California, United States, 91910
Contact: Arlene Banares 619-370-9520 abanares4@yahoo.com
Principal Investigator: James Longobardi, DPM

Dr. Jagpreet Mukker
Recruiting
Fresno, California, United States, 93726
Contact: Prabhi Mukker 559-224-5101 prabhimukker@gmail.com
Principal Investigator: Jagpreet Mukker, DPM

UCLA Medical Center Olive View
Not yet recruiting
Sylmar, California, United States, 91342
Contact: Gus Chavez 818-364-3205 gchavez@ladhs.org
Principal Investigator: Soma Wali, MD
Sub-Investigator: Aksone Nouvong, DPM

United States, Connecticut

North American Center for Limb Preservation
Recruiting
New Haven, Connecticut, United States, 06515
Contact: Michael Palladino, D.P.M. mpads1@aol.com
Principal Investigator: Peter Blume, DPM

United States, Florida

University of Miami
Recruiting
Miami, Florida, United States, 33136
Contact: Carol Kittles ckittles@med.miami.edu
Principal Investigator: Robert Kirsner, MD PhD

Bay Pines VAHCS
Recruiting
Bay Pines, Florida, United States, 33744
Contact: Diane Ochs, RN diane.ochs@med.va.gov
Principal Investigator: Wyatt Payne, MN

Karr Foot Kare
Not yet recruiting
Lakeland, Florida, United States, 33813
Contact: Teneca Brunner 863-646-5960 tbrunner1008@yahoo.com
Principal Investigator: Jeffrey Karr, DPM

United States, Georgia

Village Podiatry Group
Recruiting
Smyrna, Georgia, United States, 30080
Contact: David Helfman, DPM
Principal Investigator: Brent Nixon, DPM

United States, Illinois

Memorial Hospital
Recruiting
Belleville, Illinois, United States, 62220
Contact: Marge Groom, RN hmoosa@charter.net
Principal Investigator: Hans Moosa, MD

United States, Maryland

Johns Hopkins Bayview Medical Center
Recruiting
Baltimore, Maryland, United States, 21224
Contact: Yelena Frankel, MD 410-550-3348 yfrankel1@jhmi.edu
Contact: Katie Baran 410-550-8874 kswanso7@jhmi.edu
Principal Investigator: Gerlad Lazarus, MD

United States, Massachusetts

Boston Medical Center
Recruiting
Boston, Massachusetts, United States, 02118
Contact: Jonathan LeBretton, RN, BSN 617-414-6833 Jonathan.Lebretton@bmc.org
Principal Investigator: Vickie Driver, DPM

United States, Nevada

Advanced Foot & Ankle Center
Recruiting
Las Vegas, Nevada, United States, 89119
Contact: Joseph Dove 702-696-9005 dovejm@yahoo.com
Principal Investigator: Cyaandi Dove, DPM

United States, New York

Stony Brook University Medical Center
Recruiting
Stony Brook, New York, United States, 11794
Contact: Eileen Finnin, RN efinnin@notes.cc.sunysb.edu
Principal Investigator: Antonio Gasparis, MD

Division of Wound Healing & Regenerative Medicine NYU School of Medicine
Not yet recruiting
New York City, New York, United States, 10016
Contact: Michael Michael Golinko, MD 212-598-6000 mgolinko@gmail.com
Principal Investigator: Harold Brem, MD

Mt. Sinai School of Medicine
Recruiting
New York City, New York, United States, 10029
Contact: Tanisha Brown 212-241-4028 tanisha.brown@mssm.edu
Principal Investigator: Peter Sheehan, MD

United States, North Carolina

University of North Carolina
Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Nicole Lemire nlemire@med.unc.edu
Principal Investigator: William Marston, MD

United States, Pennsylvania

Warren General Hospital
Recruiting
Warren, Pennsylvania, United States, 16365
Contact: Jack Marnoni jmarnoni@healingwounds.com
Principal Investigator: Thomas Serena, MD

Leigh Valley Hospital
Not yet recruiting
Allentown, Pennsylvania, United States, 18105
Contact: Victoria Sabella, RN 610-969-2038 victoria.sabella@lvh.com
Principal Investigator: Scott Lipkin, DPM

United States, Texas

St. Joseph Medical Center
Not yet recruiting
Houston, Texas, United States, 77002
Contact: Moira Hayes 713-301-5707 moira.hayes@sbcglobal.net
Principal Investigator: Leon E Etter, MD

South Texas Foot Institute
Recruiting
San Antonio, Texas, United States, 78224
Contact: Diana Estrada 210-928-3668 dianaapollori@yahoo.com
Principal Investigator: Bhavesh Shah, DPM

Presbyterian Hospital of Dallas
Recruiting
Dallas, Texas, United States, 75231
Contact: Mary Walraven 214-540-1821 mwalraven@wound.com
Principal Investigator: Jeff Stone

University of Texas Medical Branch
Recruiting
Galveston, Texas, United States, 77555
Contact: Pamela Kiani 409-266-9441 pjkiani@utmb.edu
Principal Investigator: Maria Guidry, MD

Sponsors and Collaborators
Tissue Repair Company and Cardium Therapeutics

Investigators
Study Chair: Jeff Kittrelle, MD
Tissue Repair Company, 3611 Valley Centre Drive, #525
San Diego, CA 92130 USA, 858-436-1000