The safety and efficacy of beta glucan products, and specifically TR 987, in the treatment of chronic venous insufficiency ulcers has been established. This study is designed to determine the most efficient method of treatment.
This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the effectiveness of TR 987 gel. It is a two-arm, design: One group will receive twice-weekly applications of 0.1% TR 987 in a gel base plus SoC for the first 4 weeks. The other group will receive twice-weekly applications of placebo gel base plus SoC for the same period of time. After 4 weeks, both groups will receive once weekly applications of their assigned treatment for the remaining 8 weeks of the trial. The Standard of Care therapy in this study is multi-layer compression therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
TR 987 0.1%
Placebo gel twice weekly for 4 weeks, then once weekly for 8 weeks. Gel will be applied to cover the wound cavity and wound surface to a thickness of 5 mm.
New Hope Podiatry Clinic
Los Angeles, California, United States
Barry University Clinical Research
North Miami Beach, Florida, United States
Royal Research Corp
Pembroke Pines, Florida, United States
Time to complete wound closure
Time frame: 12 weeks
Percentage of subjects with complete ulcer healing
Time frame: 12 weeks
Change in ulcer size
Time frame: 4 weeks
Change in ulcer size
Time frame: 12 weeks
Incidence of adverse events
Time frame: 12 weeks
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