Tissue Repair Gel in Venous Leg Ulcers in AU/US (TRIVIA)

March 27, 2025 updated by: TR Therapeutics

A Phase 3 Randomized, Parallel Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, and Safety of TR987® 0.1% Gel Versus Standard of Care in the Treatment of Chronic Venous Insufficiency Leg Ulcers (VLU)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an outpatient, randomized, parallel- group, double-blind, multicenter, 16-week study with 2 treatment arms: TR987 0.1% gel + Standard of Care and Standard of Care alone in participants who have a non-healing Venous Leg Ulcer (VLU).

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.

Study Type

Interventional

Enrollment (Estimated)

312

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
      • Kogarah, New South Wales, Australia, 2217
      • Orange, New South Wales, Australia, 2800
      • Sydney, New South Wales, Australia, 2065
    • Victoria
      • Bendigo, Victoria, Australia, 3550
      • Ivanhoe, Victoria, Australia, 3079
      • Shepparton, Victoria, Australia, 3630
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Clincial Research Site 92
    • Michigan
      • Clinton Twp, Michigan, United States, 48038
        • Recruiting
        • Clincial Research Site 77
    • New York
      • Lake Success, New York, United States, 11042
        • Not yet recruiting
        • Clincial Research Site 82
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Clinical Research Site 76

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults 18 years and older
  • 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:

  • Target ulcer has been treated with prohibited medications or therapies.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: TR987 0.1% gel + Standard of Care
6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging)
Other Names:
  • Glucoprime
Other: 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.
Other: Standard of care
Standard of Care (wound cleansing/dressings and compression bandaging)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.
Time Frame: 16 weeks
Patient count
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 16 weeks
Patient count
16 weeks
Change from baseline in participant's perception of pain level at 12 weeks.
Time Frame: 12 weeks
Pain to be measured on a 10 point numeric rating scale
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.
Time Frame: 12 and 16 weeks
Measure the are of the wound in cm2 at baseline and at 12 and 16 weeks and calculate the percentage change
12 and 16 weeks
Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.
Time Frame: 12 weeks
Count the number of patients with complete closure and divide by the total number of patients
12 weeks
Proportion of participants with any significant reduction in pain at or before 12 weeks.
Time Frame: 12 weeks
Count the number of patients with any significant reduction in pain and divide by the total number of patients
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TR Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

November 24, 2024

First Submitted That Met QC Criteria

November 24, 2024

First Posted (Actual)

November 27, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BG003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

If clinical trial data will be published, this relevant information may be available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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