RecruitingPhase 3NCT06707103

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)

Sponsor

TR Therapeutics

Enrollment

312 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Standard of care and a drug called TR987 0.1% gel + Standard of Care for people with non healing wound, venous insufficiency of leg, and other related conditions. The study is currently recruiting participants at 12 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTR987 0.1% gel + Standard of Care

6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging)

OTHERStandard of care

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

Locations(12)

Clincial Research Site 92

Jacksonville, Florida, United States

Clincial Research Site 77

Clinton Twp, Michigan, United States

Clincial Research Site 82

Lake Success, New York, United States

Clinical Research Site 76

Fort Worth, Texas, United States

Clincial Research Site 62

Camperdown, New South Wales, Australia

Clinical Research Site 84

Kogarah, New South Wales, Australia

Clincial Research Site 78

Orange, New South Wales, Australia

Clincial Research Site 85

Sydney, New South Wales, Australia

Clincial Research Site 74

Bendigo, Victoria, Australia

Clincial Research Site 60

Ivanhoe, Victoria, Australia

Clincial Research Site 65

Shepparton, Victoria, Australia

Clincial Research Site 75

Nedlands, Western Australia, Australia

View Full Details on ClinicalTrials.gov

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NCT06707103

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