Venous Leg Ulcer (VLU)
Conditions
Brief summary
1. Incidence and severity of systemic and local adverse events (AEs) throughout the trial,, 2. Clinically significant changes in vital signs and clinical laboratory parameters (blood chemistry, hematology, coagulation) during the daily period,, 3. Incidence of discontinuation due to adverse reaction during the daily period,, 4. Pain, as assessed by Numeric Pain Rating Scale (NPRS), until the end of the weekly visits period,, 5. Time to complete wound closure from the initiation of study treatment, throughout the trial,, 6. Incidence of complete wound closure, throughout the trial,, 7. Percent change in wound area, from baseline until the end of the Weekly Visits Period, as assessed by eKare inSightTM.
Detailed description
1. Incidence of complete debridement, clinically (visually) assessed during the Daily Visits Period (up to 8 applications),, 2. Incidence of complete healthy viable granulation tissue, at the end of the Daily Visits Period, as assessed clinically,, 3. Time to the first declaration of complete debridement, from the initiation of study treatment throughout the trial,
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence and severity of systemic and local adverse events (AEs) throughout the trial,, 2. Clinically significant changes in vital signs and clinical laboratory parameters (blood chemistry, hematology, coagulation) during the daily period,, 3. Incidence of discontinuation due to adverse reaction during the daily period,, 4. Pain, as assessed by Numeric Pain Rating Scale (NPRS), until the end of the weekly visits period,, 5. Time to complete wound closure from the initiation of study treatment, throughout the trial,, 6. Incidence of complete wound closure, throughout the trial,, 7. Percent change in wound area, from baseline until the end of the Weekly Visits Period, as assessed by eKare inSightTM. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of complete debridement, clinically (visually) assessed during the Daily Visits Period (up to 8 applications),, 2. Incidence of complete healthy viable granulation tissue, at the end of the Daily Visits Period, as assessed clinically,, 3. Time to the first declaration of complete debridement, from the initiation of study treatment throughout the trial, | — |