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Tissue Repair Gel in Venous Leg Ulcers in AU/US

PHASE3RECRUITING

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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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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, or TCPo2.
  • Body mass index (BMI) ≤ 42 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.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2024-11-01

    Primary completion: 2026-12-01

    Study completion finish: 2027-02-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT06707103

    Intervention or treatment

    DRUG: TR987 0.1% gel

    OTHER: Standard of care

    Conditions

    • Venous Leg Ulcer
    • Venous Ulcer
    • Venous Stasis Ulcer
    • Venous Stasis
    • Wound Heal
    • Wound
    • Venous Insufficiency of Leg
    • Non-healing Wound

    Find a site

    Closest Location:

    Clincial Research Site 78

    Research sites nearby

    Select from list below to view details:

    • Clincial Research Site 78

      Orange, New South Wales, Australia

    • Clincial Research Site 85

      Sydney, New South Wales, Australia

    • Clincial Research Site 60

      Ivanhoe, Victoria, Australia

    • Clincial Research Site 65

      Shepparton, Victoria, Australia

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    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?

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

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.Patient count16 weeks

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome 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).Patient count16 weeks
    Change from baseline in participant's perception of pain level at 12 weeks.Pain to be measured on a 10 point numeric rating scale12 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.Measure the are of the wound in cm2 at baseline and at 12 and 16 weeks and calculate the percentage change12 and 16 weeks
    Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.Count the number of patients with complete closure and divide by the total number of patients12 weeks
    Proportion of participants with any significant reduction in pain at or before 12 weeks.Count the number of patients with any significant reduction in pain and divide by the total number of patients12 weeks

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Tissue Repair Gel in Venous Leg Ulcers in AU/US

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