NCT06707090

Tissue Repair Gel in Venous Leg Ulcers (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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: TR Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an outpatient, randomized, parallel- group, double-blind, multicenter, 16-week study with 2 treatment arms: TR987 0.1% gel + Standard of Care and Standard of Care alone in participants who have a non-healing Venous Leg Ulcer (VLU). The primary objective is to assess the proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit. Secondary endpoints include: • Proportion of participants with Complete Closure of the target ulcer at or before the Week 16 visit AND for whom the ulcer remains closed at the 3-Month Follow-Up visit after such closure (a composite endpoint). • Change from baseline in participant's perception of pain level at 12 weeks. • Percent change from baseline in the target ulcer area at 12 and 16 weeks. In the event of Complete Closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint. • Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit. • Proportion of participants with any significant reduction in pain at or before 12 weeks. There are also some supplementary and safety endpoints.

Conditions

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

Interventions

Type	Name	Description
DRUG	TR987 0.1% gel + Standard of Care	6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging)
OTHER	Standard of care	Standard of Care (wound cleansing/dressings and compression bandaging)

Timeline

• Start date: 2025-01-28
• Primary completion: 2027-12-01
• Completion: 2028-02-01
• First posted: 2024-11-27
• Last updated: 2026-02-12

Locations

33 sites across 1 country: United States

Regulatory

• FDA-regulated drug study