check_circleStudy Completed
Peripheral Arterial Disease
Bayer Identifier:
15439
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Iloprost therapy in patients with critical limb ischemia
Trial purpose
Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb ischemia by recording clinical parameters.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
126Trial Dates
August 2011 - December 2014Phase
N/ACould I Receive a placebo
NoProducts
Ilomedin (Iloprost, BAYQ6256)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations, Hungary |
Primary Outcome
- Change of limb pain at rest assessed by visual analogue scalePain relief will be defined as complete relief of pain while off analgesicsdate_rangeTime Frame:At baseline, at the end of iloprost treatment, at follow-up visits ( month 3, 6, 12)enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Incidence of ulcer healingdate_rangeTime Frame:at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)enhanced_encryptionNoSafety Issue:
- Collection of interventional / surgical procedures including 1) Rate of revascularization procedures; 2) Minor amputations; 3) Frequency and height of major amputationsdate_rangeTime Frame:at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)enhanced_encryptionNoSafety Issue:
- Mortality and/or severe cardiovascular events (AMI, stroke)date_rangeTime Frame:at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)enhanced_encryptionYesSafety Issue:
- Hemodynamic measurements: peripheral arterial blood flow and pressure on ankle / hallux level by Doppler scannerdate_rangeTime Frame:at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)enhanced_encryptionNoSafety Issue:
- Changes of transcutaneously measured tissue oxygen tension valuesdate_rangeTime Frame:at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A