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Tissue Repair Gel for treating Venous Leg Ulcers

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)

PHASE3 · TR Therapeutics · NCT06707090

This study is testing a new gel to see if it helps people with stubborn leg ulcers heal better when used with standard treatment compared to standard treatment alone.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment312 (estimated)
Ages18 Years and up
SexAll
SponsorTR Therapeutics (industry)
Drugs / interventionsradiation
Locations33 sites (Tucson, Arizona and 32 other locations)
Trial IDNCT06707090 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of TR987 0.1% gel combined with Standard of Care compared to Standard of Care alone in treating non-healing Venous Leg Ulcers (VLUs). It is a randomized, double-blind, multicenter study lasting 16 weeks, focusing on the complete closure of the target ulcer. Secondary objectives include assessing pain levels and changes in ulcer area over time. The study will also monitor the safety of the TR987 gel throughout the treatment period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with clinically diagnosed venous insufficiency and a non-healing venous ulcer between 2 cm² and 12 cm².

Not a fit: Patients with a history of certain treatments or conditions affecting the target ulcer, such as osteomyelitis or cancer, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing rates for patients with Venous Leg Ulcers.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.
* Participants considered nutritionally deficient.

Where this trial is running

Tucson, Arizona and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Venous Leg Ulcer, Venous Ulcer, Venous Stasis Ulcer, Venous Stasis, Wound Heal, Wounds, Venous Insufficiency of Leg, Non-healing Wound

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.