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Tissue Repair Gel

Tissue Repair 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

History of radiation at the target ulcer site

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 wounds that don't heal well due to poor blood flow in the veins. Participants should have a history of these ulcers and be able to follow the study's treatment plan. Specific details about who can or cannot participate were not provided.

What is being tested?

The trial is testing if TR987 0.1% gel, when used alongside standard wound care practices, is more effective at healing venous leg ulcers than standard care alone.

What are the potential side effects?

While specific side effects of TR987 0.1% gel aren't listed here, they will be monitored during the trial to ensure safety and may include typical wound treatment reactions such as discomfort or skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with venous insufficiency.

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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:

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My ulcer has not been treated with any forbidden medications or therapies.

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I have had radiation therapy at the site of my current ulcer.

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My ulcer has shrunk by at least 30% during the screening.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 and 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 and 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 16 weeks for reporting.

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.

+5 more

Awards & 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

0 / 5Eligibility criteria met