Dose Finding Study of HP802-247 in Venous Leg Ulcers

Kaplan-Meier Probability of Non-Closure

This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.

Time frame: 14 weeks - the final visit for one subject was delayed by two weeks

Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.

For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area.

Time frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first

Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13

The area of each subject's target wound was measured at each visit and the proportion of subjects with a decrease in area from baseline ≥ 50% was calculated for each treatment group.

Time frame: Over the 12 week treatment period or until the wound closed, which ever occurred first.

Percentage of Participants With Complete Wound Closure at Each Visit

Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.