Peripheral Arterial Disease
Conditions
Keywords
Critical limb ischaemia, Iloprost, Quality of life, Visual analogue scale
Brief summary
Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb ischemia by recording clinical parameters.
Interventions
Prescription and treatment of Iloprost will be decided by physicians
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who fulfill the internationally defined criteria of critical limb ischemia; * Patients who are not eligible for vascular surgery or angioplasty interventions and * Patients who are treated with iloprost infusion. * The treating physician has decided iloprost treatment before study enrollment.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of limb pain at rest assessed by visual analogue scale | At baseline, at the end of iloprost treatment, at follow-up visits ( month 3, 6, 12) | Pain relief will be defined as complete relief of pain while off analgesics |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of ulcer healing | 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 | 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) | 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 | 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 | at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12) |
Countries
Hungary
Outcome results
None listed