Peripheral Arterial Disease
Conditions
Brief summary
Incidence and severity of treatment-emergent adverse events (TEAEs) from baseline to the end of the study
Detailed description
Changes from baseline for Vascularization: Angio-CT, Changes from baseline for Hemodynamic: ankle/brachial Index, Changes from baseline for Stenosis: doppler ultrasound, Changes from baseline for Quality of life: VascuQoL-6 questionnaire, Changes from baseline for Tissue oxygenation: transcutaneous oximetry (TcPO2), Changes from baseline for Etrinabdione plasma levels (pre-dose and 3 hours post dose) at Day 1 and months 1, 3, 6,12, and EOS, Changes from baseline for selected drug and/or disease-related vascular and inflammatory biomarkers at Day 1 and months 1, 3, 6, 12, and EOS, Changes from baseline for: Clinical improvement: absolute claudication time
Interventions
DRUGEtrinabdione oral solution
Sponsors
Vivacell Biotechnology Espana S.L.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) from baseline to the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline for Vascularization: Angio-CT, Changes from baseline for Hemodynamic: ankle/brachial Index, Changes from baseline for Stenosis: doppler ultrasound, Changes from baseline for Quality of life: VascuQoL-6 questionnaire, Changes from baseline for Tissue oxygenation: transcutaneous oximetry (TcPO2), Changes from baseline for Etrinabdione plasma levels (pre-dose and 3 hours post dose) at Day 1 and months 1, 3, 6,12, and EOS, Changes from baseline for selected drug and/or disease-related vascular and inflammatory biomarkers at Day 1 and months 1, 3, 6, 12, and EOS, Changes from baseline for: Clinical improvement: absolute claudication time | — |
Countries
Spain
Outcome results
None listed