Phase 4
N=840
Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV
Peripheral Arterial Occlusive Disease
Bottom Line
View on ClinicalTrials.gov: NCT00596752 ↗Enrolled (actual)
840
Serious AEs
17.8%
Results posted
Aug 2014
Primary outcome: Primary: Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment — 49; 43; 27; 30 participants — p=0.2587
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Alprostadil (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- UCB BIOSCIENCES GmbH
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment |
49; 43; 27; 30 | 0.2587 |
| PRIMARY Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment |
32; 49; 20; 13 | 0.0173 sig |
| SECONDARY Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment |
108; 103 | — |
| SECONDARY Intensity of Rest Pain Induced by Ischemic Lesions at 24 Weeks After the End of Study Drug Treatment |
17.57; 16.38 | — |
| SECONDARY Increase/Decrease in Ulcer Area of ≥ 50 % at 24 Weeks After the End of Study Drug Treatment |
101; 98; 57; 56; 45; 48 | — |
| SECONDARY Consumption and Type of Analgesic Medication During the Course of the Study (up to 196 Days) |
300; 318; 292; 314; 295; 313 | — |
| SECONDARY Systolic Pressure at Ankle Level at 24 Weeks After the End of Study Drug Treatment |
42.83; 39.47; 39.39; 36.45 | — |
| SECONDARY Minor Amputations at 24 Weeks After the End of Study Drug Treatment |
65; 40 | — |
| SECONDARY Revascularization Procedures at 24 Weeks After the End of Study Drug Treatment |
6; 7 | — |
| SECONDARY All-cause Mortality During the Course of the Study (up to 196 Days) |
20; 15 | — |
| SECONDARY Cardiovascular Mortality During the Course of the Study (up to 196 Days) |
11; 14 | — |
| SECONDARY Cardiovascular Morbidity During the Course of the Study (up to 196 Days) |
5; 6; 3; 3 | — |
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
Data sourced from ClinicalTrials.gov (NCT00596752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.