Clinical trial NCT00596752: Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV
Official title: Multinational, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Assess the Efficacy and Safety of Prostaglandin E1 in Subjects With Critical Limb Ischemia (Fontaine Stage IV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Occlusive Disease
Keywords: Alprostadil
Prostavasin
PAOD
Fontaine Stage IV
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Aptiv Solutions
First posted: 2008-01-17
Enrollment: 840
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 45 years of age
* Subjects with macro-angiopathy, proven PAOD Stage IV with up to 2 ischaemic skin lesions for more than 2 weeks
* Subject has a complete angiography of pelvis, thigh and calf within one month of inclusion
* Systolic ankle pressure ≤ 70 mmHg in subjects without media sclerosis of the lower limb artery or systolic big toe pressure ≤ 50 mmHg in diabetics with media sclerosis of the lower limb artery
* Subject is not in the position to be primarily revascularized or refuses surgery

Exclusion Criteria:

* Imminent or foreseeable amputation
* Major amputation on the affected extremity
* History of chronic alcohol or drug abuse
* More than two ischemic ulcerations
* One ulcer ≥ 6 cm\^2, both ulcers ≤ 1 cm\^2 or at least one ulcer affecting the bone or tendons
* Acute ischemia and peripheral vascular disorders of inflammatory or immunologic origin
* Neuropathic or venous ulcers
* Buerger's disease
* Septic gangrene
* Use of vasoactive medication or prostaglandins
* Treatment with prostanoids within 3 months prior to inclusion
* Surgical or interventional measures performed on the affected extremity within 3 months prior to study drug treatment

Primary outcomes:
measure: Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment
timeFrame: At 12 weeks after the end of study drug treatment
measure: Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment
timeFrame: At 24 weeks after the end of study drug treatment
Secondary outcomes:
measure: Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment
timeFrame: At 24 weeks after the end of study drug treatment
measure: Intensity of Rest Pain Induced by Ischemic Lesions at 24 Weeks After the End of Study Drug Treatment
timeFrame: At 24 weeks after the end of study drug treatment
measure: Increase/Decrease in Ulcer Area of ≥ 50 % at 24 Weeks After the End of Study Drug Treatment
timeFrame: At 24 weeks after the end of study drug treatment
measure: Consumption and Type of Analgesic Medication During the Course of the Study (up to 196 Days)
timeFrame: During the course of the study (up to 196 days)
measure: Systolic Pressure at Ankle Level at 24 Weeks After the End of Study Drug Treatment
timeFrame: At 24 weeks after the end of study drug treatment
measure: Minor Amputations at 24 Weeks After the End of Study Drug Treatment
timeFrame: At 24 weeks after the end of study drug treatment
measure: Revascularization Procedures at 24 Weeks After the End of Study Drug Treatment
timeFrame: At 24 weeks after the end of study drug treatment
measure: All-cause Mortality During the Course of the Study (up to 196 Days)
timeFrame: During the course of the study (up to 196 days)
measure: Cardiovascular Mortality During the Course of the Study (up to 196 Days)
timeFrame: During the course of the study (up to 196 days)
measure: Cardiovascular Morbidity During the Course of the Study (up to 196 Days)
timeFrame: During the course of the study (up to 196 days)
Other outcomes:
Locations:
city: Plzen
country: Czechia
facility: 404
city: Usti Nad Labem
country: Czechia
facility: 414
city: Karlsbad
country: Germany
facility: 1
city: Aguascalientes
country: Mexico
facility: 502
city: Merida
country: Mexico
facility: 505
city: Queretaro
country: Mexico
facility: 501
city: Bydgoszcz
country: Poland
facility: 306
city: Konskie
country: Poland
facility: 321
city: Krakow
country: Poland
facility: 320
city: Lublin
country: Poland
facility: 314
city: Lublin
country: Poland
facility: 315
city: Poznan
country: Poland
facility: 316
city: Poznan
country: Poland
facility: 317
city: Szczecin
country: Poland
facility: 301
city: Szczecin
country: Poland
facility: 304
city: Warsaw
country: Poland
facility: 319
city: Warszawa
country: Poland
facility: 307
city: Warszawa
country: Poland
facility: 308
city: Warszawa
country: Poland
facility: 309
city: Warszawa
country: Poland
facility: 318
city: Wroclaw
country: Poland
facility: 312
city: Zamosc
country: Poland
facility: 322
city: Barnaul
country: Russian Federation
facility: 246
city: Chelyabinsk
country: Russian Federation
facility: 205
city: Chelyabinsk
country: Russian Federation
facility: 244
city: Ekaterinburg
country: Russian Federation
facility: 223
city: Ekaterinburg
country: Russian Federation
facility: 247
city: Irkutsk
country: Russian Federation
facility: 228
city: Kazan
country: Russian Federation
facility: 242
city: Kemerovo
country: Russian Federation
facility: 227
city: Moscow
country: Russian Federation
facility: 201
city: Moscow
country: Russian Federation
facility: 202
city: Moscow
country: Russian Federation
facility: 203
city: Moscow
country: Russian Federation
facility: 209
city: Moscow
country: Russian Federation
facility: 219
city: Moscow
country: Russian Federation
facility: 220
city: Moscow
country: Russian Federation
facility: 230
city: Moscow
country: Russian Federation
facility: 248
city: Novosibirsk
country: Russian Federation
facility: 231
city: Novosibirsk
country: Russian Federation
facility: 232
city: Omsk
country: Russian Federation
facility: 222
city: Petrozavodsk
country: Russian Federation
facility: 217
city: Rostov-on-Don
country: Russian Federation
facility: 206
city: Rostov-on-Don
country: Russian Federation
facility: 225
city: Rostov-on-Don
country: Russian Federation
facility: 236
city: Rostov-on-Don
country: Russian Federation
facility: 239
city: Ryazan
country: Russian Federation
facility: 224
city: Samara
country: Russian Federation
facility: 218
city: Saratov
country: Russian Federation
facility: 237
city: St Petersburg
country: Russian Federation
facility: 210
city: St Petersburg
country: Russian Federation
facility: 212
city: St Petersburg
country: Russian Federation
facility: 213
city: St Petersburg
country: Russian Federation
facility: 214
city: St Petersburg
country: Russian Federation
facility: 215
city: St Petersburg
country: Russian Federation
facility: 216
city: Tula
country: Russian Federation
facility: 243
city: Tumen
country: Russian Federation
facility: 238
city: Tver
country: Russian Federation
facility: 234
city: Ufa
country: Russian Federation
facility: 241
city: Volgograd
country: Russian Federation
facility: 240
city: Yaroslavl
country: Russian Federation
facility: 221
city: Dnipropetrovsk
country: Ukraine
facility: 112
city: Donetsk
country: Ukraine
facility: 109
city: Donetsk
country: Ukraine
facility: 110
city: Ivano-Frankivsk
country: Ukraine
facility: 114
city: Kharkov
country: Ukraine
facility: 111
city: Kiev
country: Ukraine
facility: 101
city: Kiev
country: Ukraine
facility: 102
city: Kiev
country: Ukraine
facility: 103
city: Kiev
country: Ukraine
facility: 104
city: Kiev
country: Ukraine
facility: 105
city: Lviv
country: Ukraine
facility: 106
city: Odessa
country: Ukraine
facility: 118
city: Odessa
country: Ukraine
facility: 119
city: Uzhgorod
country: Ukraine
facility: 113
city: Vinnytsya
country: Ukraine
facility: 116
city: Zaporozhye
country: Ukraine
facility: 107
city: Zaporozhye
country: Ukraine
facility: 108
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Lawall H, Pokrovsky A, Checinski P, Ratushnyuk A, Hamm G, Randerath O, Grieger F, Bentz JWG. Efficacy and Safety of Alprostadil in Patients with Peripheral Arterial Occlusive Disease Fontaine Stage IV: Results of a Placebo Controlled Randomised Multicentre Trial (ESPECIAL). Eur J Vasc Endovasc Surg. 2017 Apr;53(4):559-566. doi: 10.1016/j.ejvs.2016.12.035. Epub 2017 Feb 8.