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) (TRIVIA)

NCT06707090 Phase 3 RECRUITING

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.

Details

Lead sponsor	TR Therapeutics
Phase	Phase 3
Status	RECRUITING
Enrolment	312
Start date	2025-01-28
Completion	2028-02

Conditions

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

Interventions

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

Primary outcomes

• 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

Countries

United States