Safety and Efficacy Study of Urokinase for the Treatment of Diabetic Foot Syndrome and Critical Limb Ischemia

NCT ID: NCT01638585

Last Updated: 2014-04-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-11-30

Brief Summary

In this randomized clinical trial (RCT) the investigators are trying to find out whether a low-dose therapy with daily short infusions of urokinase using 10 to 21 doses over a maximum of 30 days is capable of prolonging the survival time without major amputation.

Detailed Description

August-2 is a trial embedded in the August-1 registry study. All patients enrolled in August-2 are also part of August-1, but there will be patients who are documented in the register, but will not take part in August-2. The investigators want to find out to which extent the patients in the registry are representative to the overall population suffering from this condition and how the therapeutic success of other therapy regimes can be described.

Conditions

Diabetic Foot; Critical Limb Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard therapy

patients receiving standard therapy for diabetic foot syndrome with critical limb ischemia, i. e. structured therapy of lesions with antibiosis, pressure relief and therapy of risk factors according to the relevant guidelines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

urokinase

patients receiving urokinase short infusions in addition to standard therapy

Group Type: ACTIVE_COMPARATOR

urokinase

Intervention Type: DRUG

daily short infusions, i. e. i. v. application of 1.000.000 I.E. urokinase over 30 min. for at least 10 and up to 21 days during the 30 days after randomization

Interventions

urokinase

daily short infusions, i. e. i. v. application of 1.000.000 I.E. urokinase over 30 min. for at least 10 and up to 21 days during the 30 days after randomization

Intervention Type: DRUG

Other Intervention Names

Urokinase HS medac

Eligibility Criteria

Inclusion Criteria

• age 18 years or older
• angiopathic or angioneuropathic critical limb ischemia (at least Wagner-Armstrong stadium II)
• participation in the August-1 Register
• revascularization not possible or residual ischemia after revascularization
• persisting ulcerations despite antibiosis, adjustment of blood glucose levels and debridement
• expected further hospitalization for at least 3 weeks (pressure relief and antibiosis)
• fibrinogen >= 4g/l
• signed informed consent

Exclusion Criteria

• life expectancy < 1 year
• prior major amputation
• planned major amputation
• prior therapy of the current episode of diabetic foot syndrome with urokinase (except in cases of revascularization when the duration between the intervention and randomization must not exceed 7 days)
• mechanical heart valve substitute
• cerebral event with CT-detectable changes in the last 3 months
• non-remediated proliferation retinopathy
• uncontrolled hypertension (systolic >180 mmg, diastolic >100 mmHg)
• hemorrhagic diathesis (spontaneous quick < 50%, spontaneous PTT > 40 s, thrombocytes < 100 Gpt/l)
• gastrointestinal bleeding or ulcers in the last 4 weeks
• prior reverse bypass operation
• contraindications against therapy with urokinase acc. to the SMPc
• concurrent participation in another clinical trial
• insufficient compliance
• pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GWT-TUD GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

S. Schellong, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Städt. KH Dresden-Friedrichstadt

Locations

Diabetes Klinik

Bad Mergentheim, , Germany

Vivantes Klinikum im Friedrichshain

Berlin, , Germany

Ev. KH Königin Elisabeth Herzberge

Berlin, , Germany

Martin-Luther-Krankenhaus

Berlin, , Germany

Klinikum Bielefeld gGmbH

Bielefeld, , Germany

Stiftungsklinikum Mittelrhein

Boppard, , Germany

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Klinikum Dortmund gGmbH

Dortmund, , Germany

Städtisches Krankenhaus DD-Neustadt

Dresden, , Germany

Krankenhaus Dresden-Friedrichstadt

Dresden, , Germany

Uniklinikum "Carl Gustav Carus" der TU Dresden

Dresden, , Germany

Weißeritztal Kliniken GmbH

Freital, , Germany

Asklepios Westklinikum

Hamburg, , Germany

Universitätsklinikum Leipzig AöR

Leipzig, , Germany

HELIOS Krankenhaus

Leisnig, , Germany

Klinikum Westfalen/Klinikum am Park

Lünen, , Germany

Klinikum Stuttgart, Bürgerhospital

Stuttgart, , Germany

KH der Barmherzigen Brüder

Trier, , Germany

Countries

Germany

Other Identifiers

2010-023426-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

August 2

Identifier Type: -

Identifier Source: org_study_id