Iloprost Therapy in Patients With Critical Limb Ischemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01458041
First received: October 10, 2011
Last updated: June 10, 2014
Last verified: June 2014

October 10, 2011
June 10, 2014
August 2011
May 2014   (final data collection date for primary outcome measure)
Change of limb pain at rest assessed by visual analogue scale [ Time Frame: At baseline, at the end of iloprost treatment, at follow-up visits ( month 3, 6, 12) ] [ Designated as safety issue: No ]
Pain relief will be defined as complete relief of pain while off analgesics
Same as current
Complete list of historical versions of study NCT01458041 on ClinicalTrials.gov Archive Site
  • Incidence of ulcer healing [ Time Frame: at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Iloprost Therapy in Patients With Critical Limb Ischemia
Iloprost Therapy in Patients With Critical Limb Ischemia: Evaluation of Efficacy and Safety

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Hospitalized patients

Peripheral Arterial Disease
Drug: Iloprost (Ilomedin, BAYQ6256)
Prescription and treatment of Iloprost will be decided by physicians
Group 1
Intervention: Drug: Iloprost (Ilomedin, BAYQ6256)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
126
July 2014
May 2014   (final data collection date for primary outcome measure)

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:

  • Exclusion criteria are in accordance with the Summary of Product Characteristics of Ilomedin.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
NCT01458041
15439, VE1011HU
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP