Tissue Repair Gel in Venous Leg Ulcers in AU/US

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
TR Therapeutics
Study ID
NCT06707103
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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)

Study Details

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.

Key Dates

Start date
Apr 30, 2025
Status verified
Mar 2025
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
312 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

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 ]

Central Contacts

  • Anhthu Nguyen Vice President, Global Clinical Operations
    (+61) 280 034 554
    [email protected]

Locations (4)

FacilityCityStateZIPSite coordinators
Clincial Research Site 92JacksonvilleFlorida32256-
Clincial Research Site 77Clinton TwpMichigan48038-
Clincial Research Site 82Lake SuccessNew York11042-
Clinical Research Site 76Fort WorthTexas76104-

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