ow dose Urokinase therapy by patients with diabetic foot syndrom and critical limb ischemia versus conventionel standard therapy. A randomised, open, controlled Phase III-study. - Urokinase in diabetic foot syndrome

medac Gesellschaft für klinische Spezialpräparate mbH0 个研究点目标入组 200 人开始时间: 2008年2月11日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- diabetic patients with angiopathic or angioneuropathic diabetic foot syndrome and critical limb ischemia.
•- patients with incidence of intravenous antibiotic therapy and release of pressure for three weeks
•- no possibility of surgical or interventional revascularisation (according to interdisziplinary consilium)
•- no healing tendency of ulcerations despite of antibiosis, adjustment of blood sugar and wound debridement after two-week pre-treatment
•- fibrinogen > 4.0 g/l
•- no previous major amputation
•- age > or = 18 years
•- women with child-bearing potential must use highly effective methods of contraception such as hormonal IUD; hormonal implants, injectables, combined oral contraceptives (oesrogenes and gestagenes), vaginal ring or vasectomised partner.
•- written informed consent
•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

•- prior urokinase treatment of the current episode of diabetic foot syndrom
•- need for oral anticoagulance
•- INR < 1.5 at screening
•- parenteral treatment with vasoactive substances (prostanoids, naftidrofuril, pentoxifyllin) within 48 hours prior to study inclusion
•- planned elective surgery during urokinase treatment and up to 6 weeks after finalisation of the therapy phase
•- need of dialysis and /or creatinin clearance < 20 ml/ min
•- any kind of cerebral event within 3 months prior to study inclusion
•- proliverative retinopathy (not remediated)
•- uncontrolled hypertention
•- hemorrhagic diathesis
•- gastrointestinal bleeding or ulcers
•- contraindication for urokinasetherapy according to the actual SMPC (02.2007)
•- participation in another clinical trial
•- no compliance
•- pregnant or breast feeding women

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