The study is to confirmatorily show a superior effect of Alprostadil compared to placebo on the rate of complete healing of ischemic necroses and ulcerations as well as on the frequency and height of major amputations in patients suffering from PAOD stage IV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
840
* Active Substance: Prostaglandin E1 * Pharmaceutical Form: solution for infusion * Concentration: 40 μg b.d. * Route of Administration: intravenous infusion
* Active Substance: Lactose * Pharmaceutical Form: solution for infusion * Concentration: 40 μg b.d. * Route of Administration: intravenous infusion
Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment
The assessment of ulcer area was collected per lesion with up to 2 lesions per subject (both legs could be affected). In the analysis a subject is only considered completely healed at a time point, if all ischemic lesions are reported as completely healed at that time point.
Time frame: At 12 weeks after the end of study drug treatment
Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment
Assessment of amputations was collected per leg affected by a lesion with up to 2 lesions per subject. Amputations were regarded as major if they were performed at the ankle joint level or above. Amputations of toes or part of the foot leaving a stump thereon the subject can walk were regarded as minor. An affected leg is defined as a leg with at least 1 lesion on Study Day -6 to -2 and only amputations of affected legs are considered in the efficacy analysis of amputations. A subject is counted as major/minor amputated, if at least 1 affected leg was major/minor amputated.
Time frame: At 24 weeks after the end of study drug treatment
Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment
The assessment of ulcer area was collected per lesion with up to 2 lesions per subject (both legs could be affected). In the analysis a subject is only considered completely healed at a time point, if all ischemic lesions are reported as completely healed at that time point.
Time frame: At 24 weeks after the end of study drug treatment
Intensity of Rest Pain Induced by Ischemic Lesions at 24 Weeks After the End of Study Drug Treatment
Visit values of intensity of rest pain from a visual analogue scale, ranging from 0 mm (no pain) to 100 mm (maximum conceivable pain), had to be reported in the case of presence of rest pain only. If the leading question in regard to the presence of rest pain is answered with "No" and no visit value is specified, the visit value will be set to 0 for the analysis.
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404
Pilsen, Czechia
414
Ústí nad Labem, Czechia
1
Karlsbad, Germany
502
Aguascalientes, Mexico
505
Mérida, Mexico
501
Querétaro, Mexico
306
Bydgoszcz, Poland
321
Gmina Końskie, Poland
320
Krakow, Poland
314
Lublin, Poland
...and 68 more locations
Time frame: At 24 weeks after the end of study drug treatment
Increase/Decrease in Ulcer Area of ≥ 50 % at 24 Weeks After the End of Study Drug Treatment
In case of two ulcers the worse ulcer status is analyzed. The categories of investigator assessment are: complete healing, decrease by ≥ 50 %, unchanged, increase by ≥ 50 %.
Time frame: At 24 weeks after the end of study drug treatment
Consumption and Type of Analgesic Medication During the Course of the Study (up to 196 Days)
The number of subjects who used analgesics are summarized for different time points/intervals during the course of the study.
Time frame: During the course of the study (up to 196 days)
Systolic Pressure at Ankle Level at 24 Weeks After the End of Study Drug Treatment
Systolic pressure at ankle level was measured at the Arteria tibialis posterior and the Arteria dorsalis pedis. Two individual series of measurements of arterial pressures per subject across the assessed visits were selected for the analysis. For the first analysis (worst change analysis) the series of measurements in the one artery which has the worst change from Baseline at the final measurement was used. For the second analysis (worst value analysis) the series of measurements which has the worst final post-Baseline measurement was used. The series relevant for the analyses was selected from the series for the affected leg or legs only. The selection is 1 out of up to 4 series available per subject. Series without Baseline value and series with at least 1 measurement of more than 150 mmHg were excluded from the selection process due to the suspicion of media sclerosis of the lower limb artery.
Time frame: At 24 weeks after the end of study drug treatment
Minor Amputations at 24 Weeks After the End of Study Drug Treatment
Assessment of amputations was collected per leg affected by a lesion with up to 2 lesions per subject. Amputations were regarded as major if they were performed at the ankle joint level or above. Amputations of toes or part of the foot leaving a stump thereon the subject can walk were regarded as minor. An affected leg is defined as a leg with at least 1 lesion on Study Day -6 to -2 and only amputations of affected legs are considered in the efficacy analysis of amputations. A subject is counted as major/minor amputated, if at least 1 affected leg was major/minor amputated. The number of subjects with minor amputation prior to or at 24 weeks after the end of study drug treatment is presented below.
Time frame: At 24 weeks after the end of study drug treatment
Revascularization Procedures at 24 Weeks After the End of Study Drug Treatment
The number of subjects with revascularization prior to or at 24 weeks after the end of study drug treatment is presented below.
Time frame: At 24 weeks after the end of study drug treatment
All-cause Mortality During the Course of the Study (up to 196 Days)
Time frame: During the course of the study (up to 196 days)
Cardiovascular Mortality During the Course of the Study (up to 196 Days)
Time frame: During the course of the study (up to 196 days)
Cardiovascular Morbidity During the Course of the Study (up to 196 Days)
Cardiovascular morbidity is presented as number of subjects with myocardial infarction and/or stroke during the course of the study.
Time frame: During the course of the study (up to 196 days)