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TR987 0.1% gel for Venous Leg Ulcers

This study is testing if a gel called TR987 0.1% can help heal venous leg ulcers (open sores on the leg due to poor blood flow) better than standard care alone. Standard care includes wound cleaning, dressings, and compression bandages. We want to see if adding TR987 0.1% gel leads to more ulcers completely closing within 16 weeks. The study will also gather information about the safety of TR987 0.1% gel. You might be able to join if you are an adult (18 or older) with a diagnosed venous leg ulcer that is between 2 and 12 square centimeters and has been present for at least 4 weeks. The current status of this study is unclear.

Study design
This is a randomized, double-blind study with two groups, meaning you would be randomly assigned to receive either TR987 0.1% gel plus standard care or standard care alone, and neither you nor your doctors would know which treatment you are getting. About 312 people are expected to participate.
What's involved
You would be an outpatient in this study, which lasts for 16 weeks of treatment.
Compensation
Not stated in the trial record.
Follow-up
After the 16-week treatment, some participants will be followed for 3 months to see if their ulcer remains closed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06707103

Tissue Repair Gel in Venous Leg Ulcers in AU/US

Recruiting
PHASE3Ages 18+InterventionalTreatment
TR Therapeutics
~312 participants
Updated 2025-04-02 on ClinicalTrials.gov
What's tested:TR987 0.1% gel + Standard of CareStandard of care

At a glance

Recruiting sites
5 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.
Measured over 16 weeks

Conditions

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

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Stasis ulcer

Where it's being run

12 sites across 7 states
New South Wales4
Victoria3
Florida1
Michigan1
New York1
Texas1
Western Australia1

Who to contact

Anhthu Nguyen Vice President, Global Clinical Operations
[email protected]
(+61) 280 034 554
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.16 weeks

    Patient count