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Tissue Repair Gel in Venous Leg Ulcers in AU/US

NCT06707103 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2025-04-02

No results posted yet for this 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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • TR Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2026-12-31
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06707103 on ClinicalTrials.gov