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Tissue Repair Gel
TR987 Gel for Venous Leg Ulcers (TRIVIA Trial)
Phase 3
Recruiting
Research Sponsored by TR Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Venous insufficiency has been clinically diagnosed and medically confirmed
Participants must have adequate arterial flow as confirmed by ABI/TBI, TB, SPP, or TCPo2
Must not have
Target ulcer has been treated with prohibited medications or therapies
Target ulcer decreases in area by 30% or more during screening period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 16 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to see if using TR987 0.1% gel along with the standard treatment is more effective in treating Venous Leg Ulcers compared to using the standard treatment alone. The trial
Who is the study for?
This trial is for individuals with Venous Leg Ulcers, which are non-healing wounds typically caused by poor blood circulation in the legs. Participants should have an ulcer that hasn't healed and must be able to follow the study's procedures.
What is being tested?
The trial is testing if a gel called TR987 at a concentration of 0.1%, when used alongside standard wound care practices, can better heal Venous Leg Ulcers compared to just the usual wound care methods alone.
What are the potential side effects?
While specific side effects of TR987 aren't listed, gels like this could potentially cause skin irritation or allergic reactions at the site of application.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with venous insufficiency.
Select...
My blood flow in arteries is confirmed to be adequate.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My ulcer has not been treated with any forbidden medications or therapies.
Select...
My ulcer has shrunk by at least 30% during the screening.
Select...
I have received radiation therapy at the site of my ulcer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 and 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.
Secondary study objectives
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.
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: TR987 0.1% gel + Standard of CareExperimental Treatment1 Intervention
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.
Group II: Standard of CareExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
TR TherapeuticsLead Sponsor
4 Previous Clinical Trials
430 Total Patients Enrolled