Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb ischemia by recording clinical parameters.
Study Type
OBSERVATIONAL
Enrollment
126
Prescription and treatment of Iloprost will be decided by physicians
Unnamed facility
Many Locations, Hungary
Change of limb pain at rest assessed by visual analogue scale
Pain relief will be defined as complete relief of pain while off analgesics
Time frame: At baseline, at the end of iloprost treatment, at follow-up visits ( month 3, 6, 12)
Incidence of ulcer healing
Time frame: at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)
Collection of interventional / surgical procedures including 1) Rate of revascularization procedures; 2) Minor amputations; 3) Frequency and height of major amputations
Time frame: at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)
Mortality and/or severe cardiovascular events (AMI, stroke)
Time frame: at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)
Hemodynamic measurements: peripheral arterial blood flow and pressure on ankle / hallux level by Doppler scanner
Time frame: at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)
Changes of transcutaneously measured tissue oxygen tension values
Time frame: at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)
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