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.
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 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.
Parallel
TR987 0.1% gel + Standard of Care
Drug6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging)
Standard of care
Other interventionStandard of Care (wound cleansing/dressings and compression bandaging)
Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.
Patient count
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).
Patient count
Change from baseline in participant's perception of pain level at 12 weeks.
Pain to be measured on a 10 point numeric rating scale
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.
Measure the are of the wound in cm2 at baseline and at 12 and 16 weeks and calculate the percentage change
Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.
Count the number of patients with complete closure and divide by the total number of patients
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