Tissue Repair Gel in Venous Leg Ulcers in AU/US

NCT06707103 · tracked via the Priya Life Science USA tracker

Sponsor

TR Therapeutics

Phase

Phase 3

Started

2025-04

Last updated

2025-04-02

Condition(s) studied

Venous Leg UlcerVenous UlcerVenous Stasis UlcerVenous StasisWound HealWoundVenous Insufficiency of LegNon-healing Wound

Investigational drug(s) / intervention(s)

TR987 0.1% gel + Standard of Care →Standard of care

TR987 0.1% gel + Standard of Care: 6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging)

Standard of care: Standard of Care (wound cleansing/dressings and compression bandaging)

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (12)

Facility	City	Region	Status
Clincial Research Site 92	Jacksonville	Florida	Recruiting
Clincial Research Site 77	Clinton Twp	Michigan	Recruiting
Clincial Research Site 82	Lake Success	New York	Not Yet Recruiting
Clinical Research Site 76	Fort Worth	Texas	Recruiting
Clincial Research Site 62	Camperdown	New South Wales	Not Yet Recruiting
Clinical Research Site 84	Kogarah	New South Wales	Not Yet Recruiting
Clincial Research Site 78	Orange	New South Wales	Not Yet Recruiting
Clincial Research Site 85	Sydney	New South Wales	Not Yet Recruiting
Clincial Research Site 74	Bendigo	Victoria	Not Yet Recruiting
Clincial Research Site 60	Ivanhoe	Victoria	Recruiting
Clincial Research Site 65	Shepparton	Victoria	Recruiting
Clincial Research Site 75	Nedlands	Western Australia	Not Yet Recruiting

More TR Therapeutics trials in the USA

Tissue Repair Gel in Venous Leg Ulcers (US) Recruiting

Other trials for the same condition

Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers. Recruiting

MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers Recruiting

INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone Recruiting

A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing Recruiting

Microsurfaced Grafts in Deep Burn Wounds Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06707103 on ClinicalTrials.gov ↗ ← All trials in the USA