About the MATRIX Study
What is the MATRIX clinical research study?
Clinical research studies are conducted to determine the safety and effectiveness of investigational medications and devices. The MATRIX study is testing the safety of an investigational (experimental) medication called Excellarate™ (also known as GAM501) and whether Excellarate improves healing of diabetic foot ulcers compared to placebo (an inactive substance that contains no medicine) and current standardized wound care. If eligible, you will be randomly assigned to a group (receiving either one or two doses of Excellarate plus standardized wound care), a control group (receiving one or two doses of placebo plus standardized wound care) or standardized wound care alone.
Who can participate?
In general, patients who have been diagnosed with diabetes (either Type I or Type II) and who have a foot ulcer may participate.
Other criteria that must be met to be eligible to participate include:
- 18 years of age or older
- Foot ulcer present for 6 weeks or more that has not healed
- Taking insulin or other medication to control blood sugars
- Willing to wear
a special protective shoe for the duration of the study
These are not the only criteria for participation in the MATRIX clinical research study. Only a clinical research study staff member can make the final determination of your eligibility to participate.
