Chronic venous ulcers (CVU)
Conditions
Brief summary
Complete wound closure at Week 18 already persisting for at least two weeks;, Adverse events;
Detailed description
Wound size change in percent at each post-baseline follow-up visit;, Time to complete wound closure;, Complete wound closures at each post-baseline follow-up visit;, Duration of wound closure;, Recurrence of the wound;, Quality of wound healing at each post-baseline follow-up visit;, Assessment of Quality of Life using the Wound-Quality of Life Questionnaire at V8, V11, V14;, Pain assessment as per numerical rating scale on each post-baseline efficacy follow-up visit;, Physical examination and vital signs at V14.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete wound closure at Week 18 already persisting for at least two weeks;, Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound size change in percent at each post-baseline follow-up visit;, Time to complete wound closure;, Complete wound closures at each post-baseline follow-up visit;, Duration of wound closure;, Recurrence of the wound;, Quality of wound healing at each post-baseline follow-up visit;, Assessment of Quality of Life using the Wound-Quality of Life Questionnaire at V8, V11, V14;, Pain assessment as per numerical rating scale on each post-baseline efficacy follow-up visit;, Physical examination and vital signs at V14. | — |
Countries
Germany