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)
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adults 18 years and older
• Venous insufficiency has been clinically diagnosed clinically and medically confirmed.
• Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control.
• The Venous Ulcer should be between 2 cm2 and 12 cm2 at randomization.
• Target ulcer age must be ≥ 4 weeks at Screening.
• Participants must have adequate arterial flow as confirmed by ABI/TBI, TB, SPP, TCPo2, or Duplex Doppler.
• Body mass index (BMI) ≤ 50 kg/m2.
• HbA1C ≤12%.
Locations
United States
Arizona
Clincial Research Site 21
ACTIVE_NOT_RECRUITING
Tucson
California
Clincial Research Site 43C
RECRUITING
Castro Valley
Clincial Research Site 14
RECRUITING
Fresno
Clincial Research Site 11
RECRUITING
Los Angeles
Clincial Research Site 43A
RECRUITING
San Francisco
Clincial Research Site 43B
RECRUITING
San Francisco
Florida
Clincial Research Site 47
RECRUITING
Deerfield Beach
Clincial Research Site 38
NOT_YET_RECRUITING
Hollywood
Clincial Research Site 40
NOT_YET_RECRUITING
Jacksonville
Clincial Research Site 26
RECRUITING
Miami
Clincial Research Site 13
RECRUITING
Pembrook Pines
Clincial Research Site 51
WITHDRAWN
Tamarac
Illinois
Clincial Research Site 49
RECRUITING
Springfield
North Carolina
Clincial Research Site 55
RECRUITING
Winston-salem
Ohio
Clincial Research Site 45
NOT_YET_RECRUITING
Grove City
Clincial Research Site 23
RECRUITING
Mentor
Oklahoma
Clincial Research Site 28
RECRUITING
Tulsa
Texas
Clincial Research Site 24
RECRUITING
Fort Worth
Clincial Research Site 32
RECRUITING
Houston
Clincial Research Site 46
NOT_YET_RECRUITING
San Antonio
Virginia
Clincial Research Site 18
RECRUITING
Suffolk
Contact Information
Primary
Anhthu Nguyen Vice President, Global Clinical Operations
anhthu.nguyen@trtherapeutics.com
(+61) 280 034 554
Time Frame
Start Date:2025-01-28
Estimated Completion Date:2027-02
Participants
Target number of participants:312
Treatments
Experimental: TR987 0.1% gel + Standard of Care
Participants will receive up to 16 weeks of TR987 0.1% gel topically + Standard of Care (wound cleansing/dressings and compression bandaging). Treatment will be twice weekly for the first four weeks then weekly for the remaining 12 weeks.