Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
312 participants
INTERVENTIONAL
2025-04-30
2027-02-28
Brief Summary
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Detailed Description
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The primary objective is to assess the proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.
Secondary endpoints include:
* Proportion of participants with Complete Closure of the target ulcer at or before the Week 16 visit AND for whom the ulcer remains closed at the 3-Month Follow-Up visit after such closure (a composite endpoint).
* Change from baseline in participant's perception of pain level at 12 weeks.
* Percent change from baseline in the target ulcer area at 12 and 16 weeks. In the event of Complete Closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint.
* Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.
* Proportion of participants with any significant reduction in pain at or before 12 weeks.
There are also some supplementary and safety endpoints.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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
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.
Standard of care
Standard of Care (wound cleansing/dressings and compression bandaging)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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%.
Exclusion Criteria
* History of radiation at the target ulcer site.
* Target ulcer decreases in area by 30% or more during screening period.
* History of osteomyelitis at the target ulcer within 6 months of screening.
* History of cancer in the preceding 5 years (except as noted in the protocol).
* Participants considered nutritionally deficient.
18 Years
ALL
No
Sponsors
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TR Therapeutics
INDUSTRY
Responsible Party
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Locations
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Clincial Research Site 92
Jacksonville, Florida, United States
Clincial Research Site 77
Clinton Twp, Michigan, United States
Clincial Research Site 82
Lake Success, New York, United States
Clinical Research Site 76
Fort Worth, Texas, United States
Clincial Research Site 62
Camperdown, New South Wales, Australia
Clinical Research Site 84
Kogarah, New South Wales, Australia
Clincial Research Site 78
Orange, New South Wales, Australia
Clincial Research Site 85
Sydney, New South Wales, Australia
Clincial Research Site 74
Bendigo, Victoria, Australia
Clincial Research Site 60
Ivanhoe, Victoria, Australia
Clincial Research Site 65
Shepparton, Victoria, Australia
Clincial Research Site 75
Nedlands, Western Australia, Australia
Countries
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Central Contacts
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Anhthu Nguyen Vice President, Global Clinical Operations
Role: CONTACT
Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Related Links
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Related Info
Other Identifiers
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BG003
Identifier Type: -
Identifier Source: org_study_id
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