Diabetic foot syndrome with critical limb ischemia
Conditions
Interventions
Trade Name: Urokinase HS medac
Product Name: Urokinase HS medac
Product Code: Urokinase HS medac
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Urokinase
CAS Number: 9039
Sponsors
GWT-TUD GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients = 18 years with diabetes and angiopathic or angioneuropathic diabetic foot syndrome with critical limb ischemia (at least Wagner-Armstrong stage 2C) Additional inclusion criteria: • No revascularization possible or rest ischemia after revascularization (ALP with collateral curve, to post-stenosis curve or dumb curve or ABI =65 years) yes F.1.3.1 Number of subjects for this age range 161
Exclusion criteria
Exclusion criteria: • prospective life expectancy 80 mmHg, diast. RR >100 mmHg • hemorrhagic diathesis (spontaneous-Quick 40 s, platelets <100 Gpt/l) • gastrointestinal bleeding or ulcers during the last 4 weeks • reverse bypass operation • existence of other contra-indications for a Urokinase therapy according to the current specialized information • concurrent participation in another clinical study • lacking compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Lengthening of survival free of major amputation by a low dose therapy with Urokinase as a daily short infusion with 10 to 21 doses over max. 30 days within the scope of a randomized, controlled study;Secondary Objective: • lengthening of survival free of major amputation one year after randomization • major amputation • overall mortality after 12 months • minor amputation • number of revision surgeries with minor amputations • healing of the aim lesions (DFS) • new lesions in the affected leg (index leg) • new lesions in a previously not affected leg (not index leg) • efficacy with dialysis patients ;Primary end point(s): Lengthening of the survival free of major amputation in the Urokinase group in contrast to the group treated with standard therapy. ;Timepoint(s) of evaluation of this end point: 12 months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 12 months after randomization;Secondary end point(s): • lengthening of survival free of major amputation one year after randomization • major amputation • overall mortality after 12 months • minor amputation • number of revision surgeries with minor amputations • healing of the aim lesions (DFS) • new lesions in the affected leg (index leg) • new lesions in a previously not affected leg (not index leg) • efficacy with dialysis patients | — |
Countries
Germany
Contacts
Public ContactStudienambulanz
GWT-TUD GmbH
Outcome results
None listed