Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV
ESPECIAL
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)
2 other identifiers
interventional
840
6 countries
78
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2004
Longer than P75 for phase_4
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
August 12, 2014
CompletedApril 4, 2018
March 1, 2018
9.2 years
December 21, 2007
May 5, 2014
March 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
At 24 weeks after the end of study drug treatment
Secondary Outcomes (10)
Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment
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
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
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)
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
At 24 weeks after the end of study drug treatment
- +5 more secondary outcomes
Study Arms (2)
Alprostadil
EXPERIMENTALProstavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Placebo
PLACEBO COMPARATORPlacebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Interventions
* 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
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- Surgical or interventional measures performed on the affected extremity within 3 months prior to study drug treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB BIOSCIENCES GmbHlead
- Aptiv Solutionscollaborator
Study Sites (78)
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
315
Lublin, Poland
316
Poznan, Poland
317
Poznan, Poland
301
Szczecin, Poland
304
Szczecin, Poland
307
Warsaw, Poland
308
Warsaw, Poland
309
Warsaw, Poland
318
Warsaw, Poland
319
Warsaw, Poland
312
Wroclaw, Poland
322
Zamość, Poland
246
Barnaul, Russia
205
Chelyabinsk, Russia
244
Chelyabinsk, Russia
228
Irkutsk, Russia
242
Kazan', Russia
227
Kemerovo, Russia
201
Moscow, Russia
202
Moscow, Russia
203
Moscow, Russia
209
Moscow, Russia
219
Moscow, Russia
220
Moscow, Russia
230
Moscow, Russia
248
Moscow, Russia
231
Novosibirsk, Russia
232
Novosibirsk, Russia
222
Omsk, Russia
217
Petrozavodsk, Russia
206
Rostov-on-Don, Russia
225
Rostov-on-Don, Russia
236
Rostov-on-Don, Russia
239
Rostov-on-Don, Russia
224
Ryazan, Russia
210
Saint Petersburg, Russia
212
Saint Petersburg, Russia
213
Saint Petersburg, Russia
214
Saint Petersburg, Russia
215
Saint Petersburg, Russia
216
Saint Petersburg, Russia
218
Samara, Russia
237
Saratov, Russia
243
Tula, Russia
234
Tver', Russia
238
Tyumen, Russia
241
Ufa, Russia
240
Volgograd, Russia
221
Yaroslavl, Russia
223
Yekaterinburg, Russia
247
Yekaterinburg, Russia
112
Dnipropetrovsk, Ukraine
109
Donetsk, Ukraine
110
Donetsk, Ukraine
114
Ivano-Frankivsk, Ukraine
111
Kharkiv, Ukraine
101
Kiev, Ukraine
102
Kiev, Ukraine
103
Kiev, Ukraine
104
Kiev, Ukraine
105
Kiev, Ukraine
106
Lviv, Ukraine
118
Odesa, Ukraine
119
Odesa, Ukraine
113
Uzhhorod, Ukraine
116
Vinnytsia, Ukraine
107
Zaporizhzhya, Ukraine
108
Zaporizhzhya, Ukraine
Related Publications (1)
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.
PMID: 28189475RESULT
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 17, 2008
Study Start
March 1, 2004
Primary Completion
May 1, 2013
Study Completion
July 1, 2013
Last Updated
April 4, 2018
Results First Posted
August 12, 2014
Record last verified: 2018-03