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Tissue Repair Gel in Venous Leg Ulcers (US)
Sponsor: TR Therapeutics
Summary
The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs). It will also provide additional information about the safety of drug TR987 0.1% gel.
Official title: A Phase 3 Randomized, Parallel Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, and Safety of TR987® 0.1% Gel Versus Standard of Care in the Treatment of Chronic Venous Insufficiency Leg Ulcers (VLU)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
312
Start Date
2025-01-28
Completion Date
2028-02
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
TR987 0.1% gel + Standard of Care
6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging)
Standard of care
Standard of Care (wound cleansing/dressings and compression bandaging)
Locations (33)
Clincial Research Site 21
Tucson, Arizona, United States
Clincial Research Site 43C
Castro Valley, California, United States
Clincial Research Site 14
Fresno, California, United States
Clincial Research Site 11
Los Angeles, California, United States
Clincial Research Site 43A
San Francisco, California, United States
Clincial Research Site 43B
San Francisco, California, United States
Clincial Research Site 54
Vista, California, United States
Clincial Research Site 47
Deerfield Beach, Florida, United States
Clincial Research Site 38
Hollywood, Florida, United States
Clincial Research Site 40
Jacksonville, Florida, United States
Clincial Research Site 19
Miami, Florida, United States
Clincial Research Site 26
Miami, Florida, United States
Clincial Research Site 13
Pembrook Pines, Florida, United States
Clincial Research Site 51
Tamarac, Florida, United States
Clincial Research Site 22
Chicago, Illinois, United States
Clincial Research Site 34
Chicago, Illinois, United States
Clincial Research Site 10
O'Fallon, Illinois, United States
Clincial Research Site 49
Springfield, Illinois, United States
Clincial Research Site 04
Bossier City, Louisiana, United States
Clincial Research Site 01
Lafayette, Louisiana, United States
Clincial Research Site 07
D'Iberville, Mississippi, United States
Clincial Research Site 02
McComb, Mississippi, United States
Clincial Research Site 30
New York, New York, United States
Clincial Research Site 37
Syosset, New York, United States
Clincial Research Site 55
Winston-Salem, North Carolina, United States
Clincial Research Site 45
Grove City, Ohio, United States
Clincial Research Site 23
Mentor, Ohio, United States
Clincial Research Site 28
Tulsa, Oklahoma, United States
Clincial Research Site 36
Philadelphia, Pennsylvania, United States
Clincial Research Site 24
Fort Worth, Texas, United States
Clincial Research Site 32
Houston, Texas, United States
Clincial Research Site 46
San Antonio, Texas, United States
Clincial Research Site 18
Suffolk, Virginia, United States