chronic venous ulcers (CVU)
Conditions
Brief summary
Efficacy: Complete wound closure at Week 18 already persisting for at least two weeks, Safety: Adverse events
Detailed description
Complete wound closures at each post-baseline follow-up visit, Wound size change in percent at each post-baseline follow-up visit, Quality of wound healing at each post-baseline follow-up visit, Assessment of Quality of Life using the Wound-Quality of Life Questionnaire (W-QoL) as well as the EQ-5D-5L Questionnaire and the SF-36 at V8, V11, V14, V15, V16, V17, Pain assessment as per numerical rating scale (NRS) on each post-baseline follow-up visit, Duration of wound closure, Recurrence of the wound, Time to complete wound closure, Physical examination and vital signs at V14, Assessment of immunogenicity
Interventions
DRUGPlacebo
DRUGallo-APZ2-CVU
Sponsors
Rheacell GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Complete wound closure at Week 18 already persisting for at least two weeks, Safety: Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete wound closures at each post-baseline follow-up visit, Wound size change in percent at each post-baseline follow-up visit, Quality of wound healing at each post-baseline follow-up visit, Assessment of Quality of Life using the Wound-Quality of Life Questionnaire (W-QoL) as well as the EQ-5D-5L Questionnaire and the SF-36 at V8, V11, V14, V15, V16, V17, Pain assessment as per numerical rating scale (NRS) on each post-baseline follow-up visit, Duration of wound closure, Recurrence of the wound, Time to complete wound closure, Physical examination and vital signs at V14, Assessment of immunogenicity | — |
Countries
Austria, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Slovakia, Sweden
Outcome results
None listed