Pregabalin for pain reduction in Critical Limb Ischemia

Karolinska University Hospital0 个研究点开始时间: 2005年12月12日最近更新: 2012年3月19日

试验速览

暂无简介。

•1.Rest pain, gangrene or ulcers located below the patella for a duration of at least two weeks (either one of these criteria are sufficient)
•2.One measurement of: Ankle blood pressure(ABP) <70 mm Hg, an toe blood pressure(TBP) <50, or a TcPO2<45 mm Hg, or an ABI<0.7
•(either one of these criteria are sufficient)
•3.Informed consent obtained
•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.Age < 55 years
•2.Women of childbearing potential
•3.Patients already medicating with Pregabalin or Gabapentin
•4.Creatinine clearance <30ml/min
•(Normogram assessment using serum creatinine and body weight is sufficient)
•5.Amputation necessary within two weeks
•6.Revascularization necessary within two weeks (open vascular surgery or endovascular)
•7.A medical history of clear dizzness
•8.NYHA class IV heart failure
•9.Known hypotension, or having a systolic arm blood pressure <120 mm Hg
•(two consective measurements with the patient lying supine)
•10.Simultaneous or previous (within 30 days prior to study entry) participation in a clinical study using experimental drugs or devices
•11.Mental condition making the subject unable to understand the concepts and risk of the study
•12.Known allergies against pregabalin

发起方

Karolinska University Hospital