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 (12) 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
Florida
Clincial Research Site 92
RECRUITING
Jacksonville
Michigan
Clincial Research Site 77
RECRUITING
Clinton Twp
New York
Clincial Research Site 82
NOT_YET_RECRUITING
Lake Success
Texas
Clinical Research Site 76
RECRUITING
Fort Worth
Other Locations
Australia
Clincial Research Site 74
NOT_YET_RECRUITING
Bendigo
Clincial Research Site 62
NOT_YET_RECRUITING
Camperdown
Clincial Research Site 60
RECRUITING
Ivanhoe
Clinical Research Site 84
NOT_YET_RECRUITING
Kogarah
Clincial Research Site 75
NOT_YET_RECRUITING
Nedlands
Clincial Research Site 78
NOT_YET_RECRUITING
Orange
Clincial Research Site 65
RECRUITING
Shepparton
Clincial Research Site 85
NOT_YET_RECRUITING
Sydney
Contact Information
Primary
Anhthu Nguyen Vice President, Global Clinical Operations
anhthu.nguyen@trtherapeutics.com
(+61) 280 034 554
Time Frame
Start Date:2025-04
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.
Other: Standard of Care
Participants will receive 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.