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Diabetic FootPhase 2MATRIXNCT00493051

Phase 2b Study of GAM501 in the Treatment of Diabetic Ulcers of the Lower Extremities

A Phase 2 study testing GAM501 in people with Diabetic Foot, run by Tissue Repair Company at 29 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot
What is being tested?
GAM501
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
29 sitesUnited States
Study dates
Nov 2007to Dec 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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)
  • If either beta hemolytic streptococci (in any amount) or total bacterial load of >1e6 CFU/gram of tissue is present in the screening biopsy sample at the ulcer site, the patient should be given a single 7-day course of topical antibiotics and then redebrided and biopsied for quantitative culture. A second biopsy exceeding the limits above will result in exclusion from the study due to the high risk of local infection than may adversely affect ulcer closure.
  • 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
  • Has known sensitivity to products of bovine origin
  • Life expectancy of less than 12 months
  • Patients with a definite diagnosis of any immunodeficiency disorder
  • Viral hepatitis [patient must have a negative hepatitis B surface-antigen (HBsAg) and hepatitis C antibody (HepCAb) test results obtained within 2 weeks prior to the Treatment Day (Day 1)]
  • Active, uncontrolled connective tissue disease
  • Renal failure as defined by serum creatinine >2.5 mg/dL
  • Liver function studies (e.g., AST, ALT) that are >2.0 times upper limit of normal
  • Poor nutritional status as measured by serum albumin <3.0 g/dL
  • Active cancer or a history of cancer in the 5 years prior to signing the informed consent form (however, history of basal cell carcinoma is allowed)
  • Active (i.e., recent onset of erythema, edema, and increased temperature of the foot with normal radiographs ) Charcot or other structural deformity that would prevent adequate off-loading of the study foot
  • Treatment with any systemic corticosteroid, immunosuppressive chemotherapeutic agent, antiviral, or previous/current radiation therapy to lower extremity within 30 days prior to signing the informed consent form
  • Received another investigational drug or biologic within 30 days prior to signing the informed consent form or currently participating in an investigational drug or biologic study
  • A psychiatric condition or chronic alcohol or drug abuse problem, determined from the patient's medical history, which in the Investigator's opinion may pose a threat to patient compliance
  • History of non-compliance with treatment or clinical visit attendance (i.e., this study requires that patients will comply with the protocol and ulcer care regimen)

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • Leigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • Bay Pines VAHCS

    Bay Pines, Florida, 33744

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Absolute Foot Care

    Chula Vista, California, 91910

  • Presbyterian Hospital of Dallas

    Dallas, Texas, 75231

  • Dr. Roy Kroeker DPM

    Fresno, California, 93710

  • Dr. Jagpreet Mukker

    Fresno, California, 93726

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • St. Joseph Medical Center

    Houston, Texas, 77002

  • Karr Foot Kare

    Lakeland, Florida, 33813

  • Advanced Foot & Ankle Center

    Las Vegas, Nevada, 89119

  • Long Beach VA Health Care System

    Long Beach, California, 90822

  • LAC-USC Medical Center

    Los Angeles, California, 90033

  • Innovative Medical Technologies

    Los Angeles, California, 90063

  • Banner Baywood Medical Center

    Mesa, Arizona, 85206

  • University of Miami

    Miami, Florida, 33136

  • Baptist Medical Center South

    Montgomery, Alabama, 36111

  • North American Center for Limb Preservation

    New Haven, Connecticut, 06515

  • Division of Wound Healing & Regenerative Medicine NYU School of Medicine

    New York, New York, 10016

  • Associated Foot & Ankle Specialists

    Phoenix, Arizona, 85015

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • South Texas Foot Institute

    San Antonio, Texas, 78224

  • UCLA Medical Center Olive View

    Sylmar, California, 91342

  • Aung Foothealth Clinics

    Tuscon, Arizona, 85710

  • Warren General Hospital

    Warren, Pennsylvania, 16365

  • Providence Hospital Clinical Research Center

    Washington D.C., District of Columbia, 20017

  • Foot Doctors of Watsonville

    Watsonville, California, 95076

Other trials in United States

About this study

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

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.

Conditions
Diabetic Foot
Being tested
GAM501, Placebo, Standard of care
Keywords
diabetes, nonhealing, ulcers, neuropathic
Medical subject headings
Diabetic Foot, Diabetes Mellitus, Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GAM501Biological

    Also called Excellarate

    Ad5PDGF-B formulated in a collagen gel

  • PlaceboBiological

    Collagen gel

  • Standard of careOther

    moist dressing changes daily

Study groups in NCT00493051
Study groupRoleWhat they receive
1OtherStandardized Wound Care
Receives: Other: Standard of care
2Placebo comparatorPlacebo 1 dose
Receives: Biological: Placebo
3Placebo comparatorPlacebo 2 doses
Receives: Biological: Placebo
4Active comparatorActive 1 dose
Receives: Biological: GAM501
5Active comparatorActive 2 doses
Receives: Biological: GAM501

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of GAM501 on the incidence of complete ulcer closure

    Measured: Week 12 or earlier

Secondary outcomes (5)

  1. Time to complete ulcer closure

    Measured: The time from treatment start to first visit when ulcer closure is documented

  2. The absolute change and percent change in ulcer area

    Measured: From baseline ulcer area and measured at weekly intervals through week 12

  3. The durability of ulcer closure

    Measured: Measured at 4 week intervals for 12 weeks from date of ulcer closure

  4. Ulcer healing trajectories will be assessed by plots of percentage of ulcer closure versus time

    Measured: Week 12 or earlier

  5. Safety and tolerance

    Measured: Week 12 or earlier

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00493051
Sponsor's protocol ID
SWHI-03
Acronym
MATRIX
Status last verified
Feb 2010
First submitted
25 Jun 2007
Last updated
10 Feb 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17199833

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GAM501 in people with Diabetic Foot, run by Tissue Repair Company at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of GAM501 on the incidence of complete ulcer closure (time frame: Week 12 or earlier). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00493051, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2010.

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