Peripheral arterial occlusive disease (PAOD) Fontaine stage IV MedDRA version: 7.1 Level: LLT Classification code 10062585
Conditions
Interventions
Trade Name: Prostavasin
Pharmaceutical Form:
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
Sponsors
Schwarz Pharma Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of this study is to show a superior effect of Prostavasin® compared to placebo on the rate of complete healing of ischemic necroses and ulcerations at 12 weeks after the end of treatment as well as on the frequency and height of major amputations in subjects suffering from PAOD Fontaine stage IV at 24 weeks after the end of treatment.;Secondary Objective: Secondary objectives will be to show a superior effect of Prostavasin® compared to placebo on the rate of complete healing of ischemic necroses and ulcerations at 24 weeks after the end of treatment. Furthermore, a superior effect of Prostavasin® on pain induced by ischemic lesions, perfusion pressure at ankle (big toe) level and prognostic factors as minor amputations, revascularization procedures, all-cause and cardiovascular mortality, cardiovascular morbidity (myocardial infarction, stroke, cardiac death) shall be demonstrated. ;Primary end point(s): Two primary efficacy endpoints will be tested: (1) complete healing of all necroses and ulcerations at 12 weeks after the end of treatment (Study Day 112) (2) major amputation at 24 weeks after the end of treatment (Study Day 196). | — |
Countries
Czech Republic
Outcome results
None listed