Patients with angiopathic or angioaneuropathic diabetic foot syndrome and critical limb ischemia without the possibility of surgical or interventional revascularisation MedDRA version: 9.1 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer
Conditions
Interventions
Trade Name: Urokinase HS medac
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Urokinase
CAS Number: 90 39-53-6
Concentration unit: IU international unit(s)
Concentration ty
Sponsors
medac Gesellschaft für klinische Spezialpräparate mbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: major amputation free survival within one year after randomisation.;Secondary Objective: - cumulative incidence of patients with completely healed target lesions. - time until healing of traget lesions. - cumulative incidence of major amputations. - cumulative incidence of parenteral treatment with vasoactive medication during the follow-up phase. - rate and grade of therapy caused bleedings during the treatment phase. - rate of cardiovascular events (major adverse cardiac events). - rate and characteristic of other adverse events during the treatment period. - mortality rate;Primary end point(s): major amputation free survival within one year after randomisation | — |
Countries
Germany
Outcome results
None listed