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OpenTrials
Completed

NCT Number: NCT01458041

Iloprost Therapy in Patients With Critical Limb Ischemia

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

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iloprost (Ilomedin, BAYQ6256)

Drug

Prescription and treatment of Iloprost will be decided by physicians

Primary outcomes

  1. 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)

    Pain relief will be defined as complete relief of pain while off analgesics

Secondary outcomes

  1. Incidence of ulcer healing

    Time frame: at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Iloprost Therapy in Patients With Critical Limb Ischemia: Evaluation of Efficacy and Safety

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 24, 2011
Registry last updated
Mar 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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