Tissue Repair Gel in Venous Leg Ulcers in AU/US

Last updated: March 27, 2025
Sponsor: TR Therapeutics
Overall Status: Active - Recruiting

Phase

3

Condition

Varicose Veins

Pressure Ulcer

Venous Leg Ulcers

Treatment

Standard of care

TR987 0.1% gel + Standard of Care

TR987 0.1% gel

Clinical Study ID

NCT06707103
BG003
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults 18 years and older

  • Venous insufficiency has been clinically diagnosed clinically and medicallyconfirmed.

  • Females who are neither pregnant nor breastfeeding and if of child-bearing potentialare 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

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 Design

Total Participants: 312
Treatment Group(s): 3
Primary Treatment: Standard of care
Phase: 3
Study Start date:
April 01, 2025
Estimated Completion Date:
February 28, 2027

Study 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.

Connect with a study center

  • Clincial Research Site 62

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Clinical Research Site 84

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Clincial Research Site 78

    Orange, New South Wales 2800
    Australia

    Site Not Available

  • Clincial Research Site 85

    Sydney, New South Wales 2065
    Australia

    Site Not Available

  • Clincial Research Site 74

    Bendigo, Victoria 3550
    Australia

    Site Not Available

  • Clincial Research Site 60

    Ivanhoe, Victoria 3079
    Australia

    Active - Recruiting

  • Clincial Research Site 65

    Shepparton, Victoria 3630
    Australia

    Active - Recruiting

  • Clincial Research Site 75

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Clincial Research Site 92

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Clincial Research Site 77

    Clinton Twp, Michigan 48038
    United States

    Active - Recruiting

  • Clincial Research Site 82

    Lake Success, New York 11042
    United States

    Site Not Available

  • Clinical Research Site 76

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

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