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NCT Number: NCT06707090

Tissue Repair Gel in Venous Leg Ulcers (US)

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.

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Key information

Conditions

Venous Leg Ulcer Cardiovascular Diseases Leg Ulcer Non-healing Wound Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases Venous Insufficiency of Leg Venous Stasis Venous Stasis Ulcer Venous Ulcer Wound Heal Wounds Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clincial Research Site 21, Tucson, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Participants considered nutritionally deficient.

Treatment and study plan

TR987 0.1% gel + Standard of Care

Drug

6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging)

Standard of care

Other

Standard of Care (wound cleansing/dressings and compression bandaging)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Proportion of target ulcers which reach greater than 70% closure at 12 weeks and 16 weeks

    Time frame: 12 and 16 weeks

    Measured by MolecuLight® versus baseline area at TV1 after therapeutic debridement (Complete Closure at a time point before 12 or 16 weeks shall be deemed to be >70% closed at 12 or 16-weeks, respectively, for purposes of this analysis)

  7. Proportion of target ulcers which reach greater than 90% closure at 12 weeks and 16 weeks

    Time frame: 12 and 16 weeks

    Measured by MolecuLight® versus baseline area at TV1 after therapeutic debridement (Complete Closure at a time point before 12 or 16 weeks shall be deemed to be >70% closed at 12 or 16-weeks, respectively, for purposes of this analysis)

  8. Proportion of target ulcers which reach greater than 95% closure at 12 weeks and 16 weeks

    Time frame: 12 and 16 weeks

    Measured by MolecuLight® versus baseline area at TV1 after therapeutic debridement (Complete Closure at a time point before 12 or 16 weeks shall be deemed to be >70% closed at 12 or 16-weeks, respectively, for purposes of this analysis)

Study contacts

Contact information is provided by the study sponsor or research team.

Anhthu Nguyen Vice President, Global Clinical Operations

CONTACT

[email protected]

(+61) 280 034 554

Sponsors and collaborators

Lead sponsor

TR Therapeutics

Industry

Registry information

Official study title

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)

Acronym: TRIVIA

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 27, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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