critical limb ischemia
Conditions
Brief summary
Primary endpoint: the type and frequency of adverse reactions and events assessed during the study and at the final visit.
Detailed description
Secondary endpoints: mortality rate at the final visit, amputation rate at the final visit, time to revascularization (continuous assessment), amputation-free survival time (continuous assessment), muscle perfusion in imaging studies (at the final visit compared to baseline), ankle-brachial index (at the final visit compared to baseline), change in ischemia scores (Rutherford, WiFI) (at the final visit compared to baseline), and quality of life score at the final visit.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: the type and frequency of adverse reactions and events assessed during the study and at the final visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: mortality rate at the final visit, amputation rate at the final visit, time to revascularization (continuous assessment), amputation-free survival time (continuous assessment), muscle perfusion in imaging studies (at the final visit compared to baseline), ankle-brachial index (at the final visit compared to baseline), change in ischemia scores (Rutherford, WiFI) (at the final visit compared to baseline), and quality of life score at the final visit. | — |
Countries
Poland