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Tissue Repair Gel in Venous Leg Ulcers in AU/US

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)

Who can join

Ages 18 and older · All sexes

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.
* History of cancer in the preceding 5 years (except as noted in the protocol).
* Participants considered nutritionally deficient.

About the study

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.

What is being tested

• TR987 0.1% gel + Standard of Care (drug)
• Standard of care (other)

Sponsor: TR Therapeutics · Participants: 312 · Started: 2025-04

Contact the study team

• Anhthu Nguyen Vice President, Global Clinical Operations · Phone: (+61) 280 034 554

Official record on ClinicalTrials.gov — NCT06707103

Locations in the U.S.

Conditions

• Varicose Ulcer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.