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Sponsors and Collaborators: |
Tissue Repair Company Cardium Therapeutics |
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Information provided by: | Tissue Repair Company |
ClinicalTrials.gov Identifier: | NCT00493051 |
This is a Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of one or two applications of topically applied GAM501 (Ad5PDGF-B/Bovine Type I Collagen Gel) in subjects ≥ 18 years old with non-healing diabetic foot ulcers. Approximately 210 adult subjects with Type I or Type II diabetes mellitus will be enrolled at approximately 30 investigational sites in the United States.
Condition | Intervention | Phase |
---|---|---|
Diabetic Foot |
Biological: GAM501 Biological: Placebo Other: Standard of care |
Phase II |
Study Type: | Interventional |
Study Design: | Double Blind (Caregiver, Investigator, Outcomes Assessor), Efficacy Study, Parallel Assignment, Placebo Control, Randomized, Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Single- and Double-Dose, Comparator Arm (Standard of Care), Multicenter Phase 2b Study of Topical GAM501 (Ad5PDGF-B/Bovine Type I Collagen Gel) in the Treatment of Non-Healing Diabetic Ulcers of the Lower Extremities |
Estimated Enrollment: | 210 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1
Standardized Wound Care
|
Other: Standard of care
moist dressing changes daily
|
2: Placebo Comparator
Placebo 1 dose
|
Biological: Placebo
Collagen gel
|
3: Placebo Comparator
Placebo 2 doses
|
Biological: Placebo
Collagen gel
|
4: Active Comparator
Active 1 dose
|
Biological: GAM501
Ad5PDGF-B formulated in a collagen gel
|
5: Active Comparator
Active 2 doses
|
Biological: GAM501
Ad5PDGF-B formulated in a collagen gel
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Barbara K Sosnowski, Ph.D. | 858-793-6641 ext 575 | bsosnowski@t-r-co.com |
Contact: Danette Powell | 858-793-6641 ext 584 | dpowell@t-r-co.com |
United States, Alabama | |
Baptist Medical Center South | 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 | Active, not recruiting |
Tuscon, Arizona, United States, 85710 | |
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 norma.ramos@qwestoffice.net | |
Principal Investigator: Arthur Tallis, DPM | |
United States, California | |
LAC-USC Medical Center | Active, not recruiting |
Los Angeles, California, United States, 90033 | |
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 | 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 | 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 | |
Innovative Medical Technologies | Recruiting |
Los Angeles, California, United States, 90063 | |
Contact: Lorinda Corona 323-264-6187 lorindac67@gmail.com | |
Principal Investigator: Gabriel Halperin, DPM | |
United States, Connecticut | |
North American Center for Limb Preservation | Recruiting |
New Haven, Connecticut, United States, 06515 | |
Contact: Sejal Patel drsejal79@yahoo.com | |
Principal Investigator: Peter Blume, DPM | |
United States, District of Columbia | |
Providence Hospital Clinical Research Center | Recruiting |
Washington DC, District of Columbia, United States, 20017 | |
Contact: Augustine Nwabueze 202-448-4054 anwabueze@provhosp.org | |
Principal Investigator: Ana Ibrado, MD PhD | |
United States, Florida | |
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 | Recruiting |
Lakeland, Florida, United States, 33813 | |
Contact: Teneca Brunner 863-646-5960 tbrunner1008@yahoo.com | |
Principal Investigator: Jeffrey Karr, DPM | |
University of Miami | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: Carol Kittles ckittles@med.miami.edu | |
Principal Investigator: Robert Kirsner, MD PhD | |
United States, Maryland | |
Johns Hopkins Bayview Medical Center | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: Yolanda Johnson 410-550-4724 yjonso5@jhmi.edu | |
Contact: Brenda Hensley 410-550-0731 bhensle1@jhmi.edu | |
Principal Investigator: Gerlad Lazarus, MD | |
United States, Massachusetts | |
Boston Medical Center | Recruiting |
Boston, Massachusetts, United States, 02118 | |
Contact: Joan Mulrooney, RN, BSN 617-414-6833 joan.mulrooney@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 | |
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 | |
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: Sharon McConnell smcconnell@healingwounds.com | |
Principal Investigator: Thomas Serena, MD | |
Leigh Valley Hospital | Recruiting |
Allentown, Pennsylvania, United States, 18105 | |
Contact: Victoria Sabella, RN 610-969-2038 victoria.sabella@lvh.com | |
Principal Investigator: Scott Lipkin, DPM | |
Western Pennsylvania Hospital | Recruiting |
Pittsburgh, Pennsylvania, United States, 15224 | |
Contact: Donna Houpt, RN 412-688-7910 dhoupt@wpahs.org | |
Principal Investigator: Robert Mendocino, DPM | |
United States, Texas | |
St. Joseph Medical Center | Recruiting |
Houston, Texas, United States, 77002 | |
Contact: Moira Hayes 713-301-5707 moira.hayes@sbcglobal.net | |
Principal Investigator: Leon E Etter, MD | |
Presbyterian Hospital of Dallas | Recruiting |
Dallas, Texas, United States, 75231 | |
Contact: Mary Walraven 214-540-1821 mwalraven@wound.com | |
Principal Investigator: Jeff Stone | |
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 | |
University of Texas Medical Branch | Active, not recruiting |
Galveston, Texas, United States, 77555 |
Study Chair: | Jeff Kittrelle, MD | Tissue Repair Company, 6740 Top Gun St, San Diego, CA 92121 USA, 858-259-4511 |
Responsible Party: | Tissue Repair Company ( Barbara Sosnowski/ Chief Operating Officer ) |
Study ID Numbers: | SWHI-03 |
Study First Received: | June 25, 2007 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00493051 History of Changes |
Health Authority: | United States: Food and Drug Administration |
diabetes neuropathic nonhealing ulcers |
Foot Ulcer Skin Diseases Diabetic Neuropathies Ulcer Diabetes Mellitus Vascular Diseases Endocrine System Diseases |
Diabetic Angiopathies Endocrinopathy Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
Diabetic Foot Foot Ulcer Diabetic Neuropathies Skin Diseases Diabetes Mellitus Vascular Diseases |
Endocrine System Diseases Cardiovascular Diseases Skin Ulcer Diabetes Complications Leg Ulcer Diabetic Angiopathies |