The purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone.
The study is a pivotal, prospective, randomized, controlled, open-label, multi-center study that will evaluate the effectiveness and safety of topically applied Dermal-LSR in chronic DFUs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
288
Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112)
Tuscon, Arizona, United States
Veterans Affairs Northern Health Care System, Sacramento VA Medical Center at Mather
Mather, California, United States
To determine the efficacy and safety of Dermal-LSR plus Standard of Care (SOC) for the treatment of chronic diabetic foot ulcers in comparison to treatment with SOC alone.
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San Diego Research Center 4452 Park Boulevard Suite 210, San Diego
San Diego, California, United States
Doctors Research Network
South Miami, Florida, United States
Weil Foot and Ankle Institute
Des Plaines, Illinois, United States
Hines VA Hospital
Hines, Illinois, United States
National Center for Lower Limb Preservation
Niles, Illinois, United States
Foot Care Vascular and Endovascular Specialists of Boston Medical Center
Boston, Massachusetts, United States
Joslin-Beth Israel Deaconess Foot Center, Division of Podiatry, 185 Pilgrim Road
Boston, Massachusetts, United States
North Shore Diabetic and Endocrine Associates
New Hyde Park, New York, United States
...and 2 more locations