Frequently Asked Questions
- What is a diabetic foot ulcer?
- What is Excellarate™ and how is it used?
- What is the MATRIX clinical research study?
- Who can participate in the MATRIX clinical research study?
- Are there any costs for participating in the MATRIX clinical research study?
- What can I expect if I am a participant in the MATRIX study?
- Where can I learn
more about the MATRIX clinical research study?
What is a diabetic foot ulcer?
A diabetic foot ulcer is an open sore or wound that most often occurs on the bottom of the foot, and may be present in approximately 15 percent of patients with diabetes. The wounds are a result of poor lower extremity circulation caused by the disease. Because reduced circulation is often accompanied by a decreased sensation of pain, many foot ulcers go unnoticed by the patient until they are severe enough to require medical treatment. If left untreated, these foot sores can often become infected and may eventually lead to amputation.
What is Excellarate™ and how is it used?
Excellarate (also known as GAM501) is an investigational medication that is designed to stimulate wound healing. The Gene Activated Matrix (GAM) technology provides localized and sustained delivery of the growth factor directly at the wound site. Excellarate is a topical gel that is applied once or twice to the wound over the course of the MATRIX clinical research study.
What is the MATRIX clinical research study?
The MATRIX clinical research study is currently enrolling diabetic patients with a non-healing foot ulcer at clinical centers in the United States to evaluate whether an investigational medication called Excellarate is safe and effective for wound healing compared to treatment with placebo and current standardized wound care.
Who can participate in the MATRIX clinical research study?
If you are 18 years of age or older, have a wound on your foot that has been there for 6 weeks or more and have been diagnosed with diabetes that requires treatment with insulin or other medication to control your blood sugar, you may be eligible to participate in the MATRIX clinical research study.
Please note that these are not the only criteria for acceptance into the MATRIX clinical research study. Once you have met these initial criteria and have provided permission to send your contact information to the research site in your area, you will need to have some additional testing. Only a medical professional who is a member of the clinical research study staff can make the determination of your eligibility to participate.
Are there any costs for participating in the MATRIX clinical research study?
Participation in this clinical research study is on a volunteer basis and does not involve any direct cost to you. Qualified study participants may receive study-related care, study drug and protective footwear at no cost.
What can I expect if I am a participant in the MATRIX study?
- All clinical research study participants must sign an informed consent.
An informed consent means that you are provided information about the
study, including possible side effects and benefits, by the study staff so that
you can decide whether or not you want to participate. Participation is completely
voluntary and you can choose to stop participating at any time.
- All participants will undergo tests to make sure they qualify for the clinical
research study. This is called “screening.” In addition to a medical history
and physical exam, several tests (including things such as blood tests, evaluation
of the wound, cutting away dead tissue, among others) will be required.
- If you qualify, you will be randomly assigned to one of the following groups:
an Excellarate group (4 in 7 chance, 57%) plus standardized wound care,
a placebo control group (2 in 7 chance, 28%) plus standardized wound care, or
standardized wound care alone (1 in 7 chance, 14%). If you are assigned to
the Excellarate or placebo groups, approximately half of the patients will receive
one application of Excellarate or placebo during the study. The other half of
the patients in the Excellarate and placebo groups will receive 2 applications
of Excellarate or placebo during the study.
- After you have consented to participate in the study, you will make up
to 20 visits to your study doctor over a period of up to 6 months, depending
on how your ulcer heals. Most visits will be at weekly intervals. During your
participation in the study you must be willing to wear a special protective shoe
for up to 26 weeks.
Where can I learn more about the MATRIX clinical research study?
To find out more about the MATRIX clinical research study, click here, or call 1-866-447-4848.
