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

NCT01638585 | Terminated Phase 3 DMC

• 2 other identifiers: August 22010-023426-20
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 18

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.

Conditions

Diabetic Foot; Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• Duration of survival without major amputation in urokinase group compared to group with standard therapy

  within the FU of 12 months

Secondary Outcomes (13)

• total mortality

  12 months after randomization

• minor amputation

  12 months after randomization

• Number of necessary revisions in case of minor amputation

  12 months after randomization

• complete healing of targeted lesion

  within the FU of 12 months

• new lesions on previously affected leg

  within the FU of 12 months

Study Arms (2)

standard therapy

NO INTERVENTION

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.

urokinase

ACTIVE COMPARATOR

patients receiving urokinase short infusions in addition to standard therapy

Drug: urokinase

Interventions

urokinase 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

Also known as: Urokinase HS medac

urokinase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GWT-TUD GmbH: lead

Study Sites (18)

Diabetes Klinik

Bad Mergentheim, 97980, Germany

Location

Vivantes Klinikum im Friedrichshain

Berlin, 10249, Germany

Location

Ev. KH Königin Elisabeth Herzberge

Berlin, 10365, Germany

Location

Martin-Luther-Krankenhaus

Berlin, 14193, Germany

Location

Klinikum Bielefeld gGmbH

Bielefeld, 33602, Germany

Location

Stiftungsklinikum Mittelrhein

Boppard, 56154, Germany

Location

Klinikum Chemnitz gGmbH

Chemnitz, 09113, Germany

Location

Klinikum Dortmund gGmbH

Dortmund, 44145, Germany

Location

Städtisches Krankenhaus DD-Neustadt

Dresden, 01129, Germany

Location

Krankenhaus Dresden-Friedrichstadt

Dresden, 01307, Germany

Location

Uniklinikum "Carl Gustav Carus" der TU Dresden

Dresden, 01307, Germany

Location

Weißeritztal Kliniken GmbH

Freital, 01705, Germany

Location

Asklepios Westklinikum

Hamburg, 22559, Germany

Location

Universitätsklinikum Leipzig AöR

Leipzig, 04103, Germany

Location

HELIOS Krankenhaus

Leisnig, 04703, Germany

Location

Klinikum Westfalen/Klinikum am Park

Lünen, 44536, Germany

Location

Klinikum Stuttgart, Bürgerhospital

Stuttgart, 70191, Germany

Location

KH der Barmherzigen Brüder

Trier, 54292, Germany

Location

MeSH Terms

Conditions

Diabetic Foot; Chronic Limb-Threatening Ischemia

Interventions

Urokinase-Type Plasminogen Activator

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• S. Schellong, Prof.Dr.med.

  Städt. KH Dresden-Friedrichstadt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: July 11, 2012
• Study Start: June 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 7, 2014

Record last verified: 2014-04

Locations

DE (18)