Tissue Repair Gel in Venous Leg Ulcers (US)

Conditions

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

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

Jan 28, 2025

Status verified

Sep 2025

Primary completion

Dec 31, 2027

Completion

Feb 29, 2028

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

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 (33)

Find similar trials in Tucson, AZ

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