Iloprost Therapy in Patients With Critical Limb Ischemia - Full Text View

Purpose

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

Condition	Intervention
Peripheral Arterial Disease	Drug: Iloprost (Ilomedin, BAYQ6256)

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Iloprost Therapy in Patients With Critical Limb Ischemia: Evaluation of Efficacy and Safety

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Arterial Disease

Drug Information available for: Iloprost

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	126
Study Start Date:	August 2011
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1	Drug: Iloprost (Ilomedin, BAYQ6256) Prescription and treatment of Iloprost will be decided by physicians

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Hospitalized patients

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458041

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

Hungary
	Recruiting
Many locations, Hungary

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Director, BHC Pharmaceuticals- Bayer Hungaria Kft.
ClinicalTrials.gov Identifier:	NCT01458041 History of Changes
Other Study ID Numbers:	15439, VE1011HU
Study First Received:	October 10, 2011
Last Updated:	May 10, 2013
Health Authority:	Hungary: Council of Scientific And Research Ethics

Keywords provided by Bayer:

Critical limb ischaemia
Iloprost
Quality of life
Visual analogue scale

Additional relevant MeSH terms:

Ischemia
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

Cardiovascular Diseases
Iloprost
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013