E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with angiopathic or angioaneuropathic diabetic foot syndrome and critical limb ischemia without the possibility of surgical or interventional revascularisation |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012664 |
E.1.2 | Term | Diabetic foot ulcer |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
major amputation free survival within one year after randomisation. |
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E.2.2 | Secondary objectives of the trial |
- 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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
major amputation free survival within one year after randomisation |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
standard therapy acc. to the national care guideline for diabetic foot syndrome (V 2.4, December 200 |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
It is referred to protocol chapter 5.4 |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |