About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Target ulcer has been treated with prohibited medications or therapies.
History of radiation at the target ulcer site.
Target ulcer decreases in area by 30% or more during screening period.
History of osteomyelitis at the target ulcer within 6 months of screening.
Trial design
Treatments tested in this trial
- TR987 0.1% gel + Standard of Care
- Standard of care