Actively Recruiting
Tissue Repair Gel in Venous Leg Ulcers in AU/US
Led by TR Therapeutics · Updated on 2025-04-02
312
Participants Needed
12
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 who are not pregnant or breastfeeding and use acceptable birth control if of child-bearing 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 ABI, TBI, TB, SPP, TCPo2, or Duplex Doppler
- Body mass index (BMI) of 50 kg/m2 or less
- HbA1C level of 12% or less
You will not qualify if you...
- Target ulcer treated 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 within the last 5 years (with exceptions as noted in the protocol)
- Participants considered nutritionally deficient
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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