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)
TR Therapeutics
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 tr…
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 92Jacksonville, Florida
- Clincial Research Site 77Clinton Twp, Michigan
- Clincial Research Site 82Lake Success, New York
- Clinical Research Site 76Fort Worth, Texas
- Clincial Research Site 62Camperdown, New South Wales
- Clinical Research Site 84Kogarah, New South Wales