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TR987 0.1% gel for Venous Leg Ulcers

This study is looking into whether a gel called TR987 0.1% combined with standard care (wound cleaning, dressings, and compression bandages) works better than standard care alone for treating venous leg ulcers (VLUs). VLUs are sores on the leg caused by poor blood flow. Researchers also want to learn more about the safety of TR987 0.1% gel. You might be able to join if you are an adult aged 18 or older with a VLU between 2 and 12 square centimeters that has been present for at least 4 weeks. The main goal is to see how many participants' ulcers completely close within 16 weeks. The current status of this study is unclear.

Study design
This is a randomized, double-blind study, meaning participants are randomly assigned to one of two groups, and neither you nor your doctors will know which treatment you are receiving. It involves about 312 participants across multiple locations.
What's involved
You would receive either TR987 0.1% gel plus standard care or standard care alone for 16 weeks. The study involves regular outpatient visits.
Compensation
Not stated in the trial record.
Follow-up
After the 16-week treatment, researchers will check if your ulcer remains closed at a 3-month follow-up visit.

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

NCT06707090

Tissue Repair Gel in Venous Leg Ulcers (US)

Recruiting
PHASE3Ages 18+InterventionalTreatment
TR Therapeutics
~312 participants
Updated 2026-02-12 on ClinicalTrials.gov
What's tested:TR987 0.1% gel + Standard of CareStandard of care

At a glance

Recruiting sites
24 of 33 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
Wounds
Venous Insufficiency of Leg
Non-healing Wound

Explore related trials

Stasis ulcer

Where it's being run

33 sites across 13 states
Florida7
California6
Illinois4
Texas3
Louisiana2
Mississippi2
New York2
Ohio2

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.
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