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
2025-01-28
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
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)
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 21
Tucson, Arizona, United States
Clincial Research Site 43C
Castro Valley, California, United States
Clincial Research Site 14
Fresno, California, United States
Clincial Research Site 11
Los Angeles, California, United States
Clincial Research Site 43A
San Francisco, California, United States
Clincial Research Site 43B
San Francisco, California, United States
Clincial Research Site 47
Deerfield Beach, Florida, United States
Clincial Research Site 38
Hollywood, Florida, United States
Clincial Research Site 40
Jacksonville, Florida, United States
Clincial Research Site 26
Miami, Florida, United States
Clincial Research Site 13
Pembrook Pines, Florida, United States
Clincial Research Site 51
Tamarac, Florida, United States
Clincial Research Site 49
Springfield, Illinois, United States
Clincial Research Site 55
Winston-Salem, North Carolina, United States
Clincial Research Site 45
Grove City, Ohio, United States
Clincial Research Site 23
Mentor, Ohio, United States
Clincial Research Site 28
Tulsa, Oklahoma, United States
Clincial Research Site 24
Fort Worth, Texas, United States
Clincial Research Site 32
Houston, Texas, United States
Clincial Research Site 46
San Antonio, Texas, United States
Clincial Research Site 18
Suffolk, Virginia, United States
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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Related Links
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Related Info
Other Identifiers
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BG002
Identifier Type: -
Identifier Source: org_study_id
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