Peripheral Arterial DiseaseNCT01458041
Iloprost Therapy in Patients With Critical Limb Ischemia
An observational study of Peripheral Arterial Disease, run by Bayer at 1 site in Hungary.
Trial summary
Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb ischemia by recording clinical parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Iloprost (Ilomedin, BAYQ6256)
- How many people
- 126 participants
- Where
- 1 siteHungary
- Study dates
- Aug 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria are in accordance with the Summary of Product Characteristics of Ilomedin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Iloprost (Ilomedin, BAYQ6256)
- Keywords
- Critical limb ischaemia, Iloprost, Quality of life, Visual analogue scale
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iloprost (Ilomedin, BAYQ6256)Drug
Prescription and treatment of Iloprost will be decided by physicians
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Iloprost (Ilomedin, BAYQ6256) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of limb pain at rest assessed by visual analogue scale
Pain relief will be defined as complete relief of pain while off analgesics
Measured: At baseline, at the end of iloprost treatment, at follow-up visits ( month 3, 6, 12)
Secondary outcomes (5)
Incidence of ulcer healing
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458041
- Sponsor's protocol ID
- 15439
- Other IDs
- VE1011HU
- Status last verified
- Feb 2015
- First submitted
- 10 Oct 2011
- Last updated
- 2 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iloprost Therapy in Patients With Critical Limb Ischemia: Evaluation of Efficacy and Safety
- ClinicalTrials.gov ID
- NCT01458041
- Acronym / sponsor ID
- 15439
- Conditions
- Peripheral Arterial Disease
- Keywords
- Critical limb ischaemia, Iloprost, Quality of life, Visual analogue scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb ischemia by recording clinical parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Iloprost (Ilomedin, BAYQ6256) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion criteria are in accordance with the Summary of Product Characteristics of Ilomedin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iloprost (Ilomedin, BAYQ6256)Prescription and treatment of Iloprost will be decided by physicians | Drug | Group 1 |
Primary outcome
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
5 secondary outcomes
Incidence of ulcer healing
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Bayer at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2015.