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

Treatment groups

312 Participants
are divided into 2 treatment groups

Locations

33
Arizona
Clincial Research Site 2185715, Tucson United States
California
Clincial Research Site 43C94546, Castro Valley United States
Clincial Research Site 1493710, Fresno United States
Clincial Research Site 1190063, Los Angeles United States

Sponsors and collaborators

TR Therapeutics

Lead sponsor