Phase 2b Study of GAM501 in the Treatment of Diabetic Ulcers of the Lower Extremities
MATRIX
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
1 other identifier
interventional
124
1 country
29
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2007
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2007
CompletedFirst Posted
Study publicly available on registry
June 27, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFebruary 10, 2010
February 1, 2010
2.1 years
June 25, 2007
February 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of GAM501 on the incidence of complete ulcer closure
Week 12 or earlier
Secondary Outcomes (5)
Time to complete ulcer closure
The time from treatment start to first visit when ulcer closure is documented
The absolute change and percent change in ulcer area
From baseline ulcer area and measured at weekly intervals through week 12
The durability of ulcer closure
Measured at 4 week intervals for 12 weeks from date of ulcer closure
Ulcer healing trajectories will be assessed by plots of percentage of ulcer closure versus time
Week 12 or earlier
Safety and tolerance
Week 12 or earlier
Study Arms (5)
1
OTHERStandardized Wound Care
2
PLACEBO COMPARATORPlacebo 1 dose
3
PLACEBO COMPARATORPlacebo 2 doses
4
ACTIVE COMPARATORActive 1 dose
5
ACTIVE COMPARATORActive 2 doses
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 years or older
- Diagnosis of diabetes mellitus (Type I or II) requiring insulin or hypoglycemic agents to control blood sugars.
- Cutaneous, lower extremity ulcer of the foot that is ≥1.5 and ≤10.0 cm² in size and Wagner Classification Grade 1 in appearance. Note - Ulcer area must be calculated at Screening Visit and on the Treatment Day (Day 1) using measurements obtained by tracing the ulcer perimeter after debridement to confirm patient eligibility prior to randomization.
- Documented ulcer presence for ≥6 weeks prior to signing the informed consent form
- Recently debrided ulcer (within 2 weeks from screening visit)
- Ulcer free of all necrotic soft tissue
- Affected limb transcutaneous partial pressure oxygen (TcpO2) \>40mmHg; or a toe pressure ≥40mmHg; or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) at screening
- Inability to perceive 10 grams pressure using a Semmes-Weinstein 5.07 monofilament in the peri-ulcer area
- Willing to adhere to wearing off-loading orthopedic shoe for up to 16 weeks (i.e., through 2 weeks after ulcer closure) starting on Day -14 (the first day of the screening run-in period)
- Willing to adhere to wearing customized shoes during the durability phase of the study
- Females of child-bearing potential must have a negative serum beta human chorionic gonadotropin hormone (ßhCG) test result from a sample obtained in the 7 days prior to Treatment Day 1 and be neither breastfeeding nor intending to become pregnant during the study
- All individuals (study patients/partners) of childbearing potential must agree to use a method of contraception deemed acceptable by the Investigator or agree to remain abstinent throughout the study
- Be able to understand and sign an informed consent form before entering into the study, and must be willing to comply with all study procedures
You may not qualify if:
- Any unstable medical condition judged by the Investigator or Medical Monitor that would cause the study to be detrimental to the patient
- Hemoglobin Alc (HbA1c) test result of \>12% documented at the Screening Visit
- Ulcers caused primarily by untreated vascular insufficiency; or ulcers with an etiology not related to diabetes
- Ulcers on the heel
- More than three ulcers on the target lower extremity
- The ulcer to be studied is not anatomically distinct from another ulcer(s) (i.e., separated by \<1 cm from another ulcer or would interfere with standard of care treatment of another ulcer). Only a single ulcer can be treated in this study.
- Ulcers which decrease in area by \>30% during the screening 2-week run-in period
- Ulcers with underlying osteomyelitis
- Patients presenting with the clinical characteristics of cellulitis at the ulcer site (suppurative inflammation involving particularly the subcutaneous tissue, often mild erythema, tenderness, malaise, chills and fever)
- Revascularization surgery on the leg with the wound to be treated ≤8 weeks prior to signing the informed consent form
- Surgery to lengthen Achilles tendon on the leg with the wound to be treated ≤8 weeks prior to signing the informed consent form
- Necrosis, purulence, or sinus tracts that cannot be removed by debridement on foot to be treated
- Needs concurrent topical antimicrobials to treat the ulcer site, or received such therapies within 7 days prior to signing the informed consent form
- Received dermal substitute or living skin equivalent (e.g., Dermagraft® or Appligraf®) within 30 days prior to signing the informed consent form
- Received prior PDGF-BB (Regranex®/becaplermin) therapy within 30 days prior to signing the informed consent form
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tissue Repair Companylead
- Cardium Therapeuticscollaborator
Study Sites (29)
Baptist Medical Center South
Montgomery, Alabama, 36111, United States
Banner Baywood Medical Center
Mesa, Arizona, 85206, United States
Associated Foot & Ankle Specialists
Phoenix, Arizona, 85015, United States
Aung Foothealth Clinics
Tuscon, Arizona, 85710, United States
Absolute Foot Care
Chula Vista, California, 91910, United States
Dr. Roy Kroeker DPM
Fresno, California, 93710, United States
Dr. Jagpreet Mukker
Fresno, California, 93726, United States
Long Beach VA Health Care System
Long Beach, California, 90822, United States
LAC-USC Medical Center
Los Angeles, California, 90033, United States
Innovative Medical Technologies
Los Angeles, California, 90063, United States
UCLA Medical Center Olive View
Sylmar, California, 91342, United States
Foot Doctors of Watsonville
Watsonville, California, 95076, United States
North American Center for Limb Preservation
New Haven, Connecticut, 06515, United States
Providence Hospital Clinical Research Center
Washington D.C., District of Columbia, 20017, United States
Bay Pines VAHCS
Bay Pines, Florida, 33744, United States
Karr Foot Kare
Lakeland, Florida, 33813, United States
University of Miami
Miami, Florida, 33136, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Advanced Foot & Ankle Center
Las Vegas, Nevada, 89119, United States
Division of Wound Healing & Regenerative Medicine NYU School of Medicine
New York, New York, 10016, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Leigh Valley Hospital
Allentown, Pennsylvania, 18105, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
Warren General Hospital
Warren, Pennsylvania, 16365, United States
Presbyterian Hospital of Dallas
Dallas, Texas, 75231, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
St. Joseph Medical Center
Houston, Texas, 77002, United States
South Texas Foot Institute
San Antonio, Texas, 78224, United States
Related Publications (1)
Steed DL, Attinger C, Colaizzi T, Crossland M, Franz M, Harkless L, Johnson A, Moosa H, Robson M, Serena T, Sheehan P, Veves A, Wiersma-Bryant L. Guidelines for the treatment of diabetic ulcers. Wound Repair Regen. 2006 Nov-Dec;14(6):680-92. doi: 10.1111/j.1524-475X.2006.00176.x. No abstract available.
PMID: 17199833BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jeff Kittrelle, MD
Tissue Repair Company, 6740 Top Gun St, San Diego, CA 92121 USA, 858-259-4511
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 25, 2007
First Posted
June 27, 2007
Study Start
November 1, 2007
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
February 10, 2010
Record last verified: 2010-02