Multinational, prospective, randomized, double-blind, placebo-controlled, parallel groups study to assess the efficacy and safety of Prostaglandin E1 in subjects with circulatory disturbance of a limb - ESPECIA
- Conditions
- Peripheral arterial occlusive disease (PAOD) Fontaine stage IVMedDRA version: 7.1Level: LLTClassification code 10062585
- Registration Number
- EUCTR2005-001970-29-CZ
- Lead Sponsor
- Schwarz Pharma Deutschland GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
1. Subject is informed and given ample time and opportunity to think about her/his
participation and has given her/his written informed consent.
2. Subject is willing and able to comply with all trial requirements.
3. Male or female subjects of at least 45 years of age.
4. Non-diabetic as well as diabetic subjects (type II) with macro-angiopathy, each
with proven PAOD and presenting up to 2 ischemic skin lesions for more than 2
weeks with or without rest pain (PAOD Fontaine stage IV). Skin lesions may not
exceed an area of 6 cm2 and at least one lesion has to be larger than 1 cm2.
5. Subject has a last complete angiography (conventional or better) of the pelvis,
the thigh and the calf performed within one month of inclusion.
6. 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.
7. Subject’s life expectancy is =180 days (investigator’s judgment).
8. Subject is not in the position to be primarily revascularized (ie, subjects for whom
revascularization will in the investigator’s opinion most probably only bring
incomplete perfusion, or subjects with a high risk of failure/amputation or any
other safety risk associated with the revascularization procedure. The
investigator’s opinion should be in agreement with surgeons/interventional
radiologists present at the location) OR Subject is in the position to be primarily
revascularized but refuses surgery (refusal will be documented and signed by the
subject).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Subject has an imminent or foreseeable amputation.
2. Subject has a major amputation on the affected extremity.
3. Subject has previously participated in this trial or subject has previously been
assigned to treatment in a trial of the drug under investigation in this trial.
4. Subject has participated in another trial of an investigational drug or a medical
device within the last 30 days or is currently participating in another trial of an
investigational drug or a medical device.
5. Subject has a history of chronic alcohol or drug abuse.
6. Subject has any medical or psychiatric condition that in the opinion of the
investigator can jeopardize or would compromise the subject’s ability to
participate in this trial.
7. Subject has a known hypersensitivity to any components of the investigational
product(s) as stated in this protocol.
8. Subject has more than two ischemic ulcerations (persistent, non-healing
ulcerations or gangrene).
9. Subject presents at least one ulcer =6 cm2, both ulcers =1 cm2 or at least one
ulcer affecting the bone or tendons.
10. Subject has acute ischemia and peripheral vascular disorders of inflammatory or
immunologic origin.
11. Subject has venous ulcers.
12. Subject has neuropathic ulcers.
13. Subject has Buerger's disease.
14. Subject has septic gangrene.
15. Subject concomitantly uses vasoactive medication (eg, naftidrofuryl,
pentoxifylline, buflomedil, cilostazol) or other prostaglandins.
16. Subject was treated with prostanoids within 3 months prior to inclusion in this
study.
17. Subject presents laboratory values outside the normal range unless considered
not clinically relevant by the investigator.
18. Subject had surgical or other interventional measures performed on the affected
extremity within 3 months prior to commencement of study drug treatment.
19. Subject had a myocardial infarction within 6 months prior to commencement of
study drug treatment.
20. Subject with mental or psychiatric conditions which suggest inability to
understand written and verbal instructions, in particular regarding the risks and
inconveniences he/she will be exposed to as a result of their participation in the
study.
21. Subject has a known or suspected uncooperative behavior.
22. Subject has a clinically significant hepatic disease or dysfunction or renal
dysfunction (creatinine >2.0 mg/dl).
23. Subject has an increased risk of hemorrhage.
24. Subject has a diabetic nephropathy with albuminuria (protein >1.5 g).
25. Subject is pregnant or breast feeding.
26. Subject uses an inadequate method of contraception.
27. Subject has to undergo ongoing dialysis.
28. Subject has an inadequately controlled angina pectoris.
29. Subject has an inadequately controlled cardiac failure (NYHA grade III and IV).
30. Subject has an inadequately controlled cardiac arrhythmia.
31. Subject has upper grade cardiac valve disorders.
32. Subject has a history and/or suspicion of pulmonary edema or pulmonary
infiltration.
33. Subject has a severe chronic obstructive pulmonary disease.
34. Subject has a venoocclusive lung disease.
35. Subject has paralyzed extremities.
36. Subject has frostbite.
37. Subject is treated with epidural spinal cord stimulation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method