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

Conditions: Patients with angiopathic or angioaneuropathic diabetic foot syndrome and critical limb ischemia without the possibility of surgical or interventional revascularisation
MedDRA version: 9.1Level: LLTClassification code 10012664Term: Diabetic foot ulcer

Registration Number: EUCTR2007-005916-15-DE

Lead Sponsor: medac Gesellschaft für klinische Spezialpräparate mbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

- 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

Exclusion Criteria

- 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