MedPath

Iloprost Therapy in Patients With Critical Limb Ischemia

Completed
Conditions
Peripheral Arterial Disease
Interventions
Registration Number
NCT01458041
Lead Sponsor
Bayer
Brief Summary

Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb ischemia by recording clinical parameters.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
126
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.
Read More
Exclusion Criteria
  • Exclusion criteria are in accordance with the Summary of Product Characteristics of Ilomedin.
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Group 1Iloprost (Ilomedin, BAYQ6256)-
Primary Outcome Measures
NameTimeMethod
Change of limb pain at rest assessed by visual analogue scaleAt 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 Outcome Measures
NameTimeMethod
Collection of interventional / surgical procedures including 1) Rate of revascularization procedures; 2) Minor amputations; 3) Frequency and height of major amputationsat 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)
Incidence of ulcer healingat 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 scannerat baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)
Changes of transcutaneously measured tissue oxygen tension valuesat baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)
© Copyright 2025. All Rights Reserved by MedPath