Actively Recruiting
A Phase 3 Randomized, Double-Blind Study Evaluating TR987 0.1% Gel Versus Standard of Care for Treating Chronic Venous Leg Ulcers
Led by TR Therapeutics · Updated on 2025-04-02
312
Participants Needed
12
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying participants with chronic Venous Leg Ulcers (VLUs) to see if adding TR987 0.1% gel to the Standard of Care improves healing compared to Standard of Care alone. This Phase 3, randomized, double-blind trial aims to evaluate the effectiveness and safety of the TR987 gel in treating VLUs, a type of non-healing wound caused by venous insufficiency. Participants will be assigned to one of two groups: one group will receive TR987 0.1% gel applied topically along with Standard of Care treatments like wound cleansing, dressings, and compression bandaging; the other group will receive Standard of Care alone. Treatments will be applied twice weekly for the first four weeks, then once weekly for the following 12 weeks, totaling up to 16 weeks of treatment. During the study, participants will have their target ulcer monitored for complete closure at various time points, including the 12- and 16-week marks, as well as follow-up at three months after closure. Pain levels and changes in ulcer size will also be assessed. Safety and tolerability will be tracked throughout the trial. Participation involves regular visits for treatment and evaluation over the 16-week treatment period, with additional follow-up to assess lasting ulcer closure.
CONDITIONS
Brief Title
Tissue Repair Gel in Venous Leg Ulcers in AU/US
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years and older
- Clinically and medically confirmed venous insufficiency
- Females not pregnant or breastfeeding and using acceptable birth control if of childbearing potential
- Venous ulcer size between 2 cm² and 12 cm² at randomization
- Target ulcer age of at least 4 weeks at screening
- Adequate arterial blood flow confirmed by tests such as ABI, TBI, or Doppler
- Body mass index of 50 kg/m² or less
- HbA1C level of 12% or less
You will not qualify if you...
- Target ulcer treated previously with prohibited medications or therapies
- History of radiation at the target ulcer site
- Target ulcer area decreased by 30% or more during screening
- History of osteomyelitis at the target ulcer within 6 months before screening
- History of cancer in the past 5 years (exceptions noted in protocol)
- Participants considered nutritionally deficient
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks
Participants receive either TR987 0.1% gel plus Standard of Care or Standard of Care alone for the treatment of venous leg ulcers.
Twice weekly visits for the first 4 weeks, then weekly visits for the remaining 12 weeks
Duration - 3 months after treatment ends
Participants are followed for 3 months after treatment to assess ulcer closure and other outcomes.
1 follow-up visit
Trial Site Locations
Total: 12 locations
1
Clincial Research Site 92
Jacksonville, Florida, United States, 32256
Actively Recruiting
2
Clincial Research Site 77
Clinton Twp, Michigan, United States, 48038
Actively Recruiting
3
Clincial Research Site 82
Lake Success, New York, United States, 11042
Not Yet Recruiting
4
Clinical Research Site 76
Fort Worth, Texas, United States, 76104
Actively Recruiting
5
Clincial Research Site 62
Camperdown, New South Wales, Australia, 2050
Not Yet Recruiting
6
Clinical Research Site 84
Kogarah, New South Wales, Australia, 2217
Not Yet Recruiting
7
Clincial Research Site 78
Orange, New South Wales, Australia, 2800
Not Yet Recruiting
8
Clincial Research Site 85
Sydney, New South Wales, Australia, 2065
Not Yet Recruiting
9
Clincial Research Site 74
Bendigo, Victoria, Australia, 3550
Not Yet Recruiting
10
Clincial Research Site 60
Ivanhoe, Victoria, Australia, 3079
Actively Recruiting
11
Clincial Research Site 65
Shepparton, Victoria, Australia, 3630
Actively Recruiting
12
Clincial Research Site 75
Nedlands, Western Australia, Australia, 6009
Not Yet Recruiting
Research Team
A
Anhthu Nguyen Vice President, Global Clinical Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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