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Completed

NCT Number: NCT00537498

Urokinase Therapy in Diabetic Foot Syndrome

The purpose of this study is to evaluate whether a treatment with urokinase (500 000 or 1 000 000 IU) can lead to ulcer-healing, lower rate of major amputation, and prolonged survival in patients with diabetic foot syndrome.

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Key information

Conditions

Diabetic Foot Arterial Occlusive Disease Arterial Occlusive Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Ischemia Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitätsklinikum Carl Gustav Carus UniversitätsGefäßcentrum

Dresden, 01307, Germany

About this study

Patients with diabetic foot ulceration and critical limb ischemia have a high risk of major amputation especially if limbs cannot be revascularized. Urokinase is effective in improving the microcirculation in critical limb ischemia by lowering fibrinogen and might improve outcomes. There are however no data on the efficacy and safety of urokinase treatment in terms of survival free of major amputation, ulcer healing and the rate of minor and major bleeding. Therefore this trial is conducted to investigate the effect of urokinase treatment on these parameters.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • angiopathic or angioneuropathic diabetic foot lesions
  • critical limb ischemia
  • no surgical or interventional treatment option

Exclusion criteria

  • feasibility of vascular surgery or angioplasty
  • prior treatment of the current ulceration with urokinase
  • need for dialysis
  • creatinine > 180µmol/l
  • any kind of cerebral event less than three months before inclusion into the study
  • proliferative retinopathy (not remediated)
  • uncontrolled hypertension
  • hemorrhagic diathesis
  • gastrointestinal bleeding
  • need for oral anticoagulation
  • mental disorders
  • pregnancy
  • participation in another study

Treatment and study plan

Urokinase

Drug

Daily intravenous application of urokinase over 30 minutes

Dosage:

If plasma fibrinogen is > 2,5g/l application of 1 000 000 IU Urokinase If plasma fibrinogen is < 2,5g/l application of 500 000 IU Urokinase If plasma fibrinogen is < 1,6g/l treatment must be stopped and continued after rising up to >2g/l

Primary outcomes

  1. Number of patients being alive, having no major amputation and healed ulceration

    Time frame: 12 months

Secondary outcomes

  1. Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

medac GmbH

Industry

Registry information

Official study title

Phase II Study of Urokinase Therapy for Treatment of Angiopathic or Angioneuropathic Diabetic Foot Syndrome

Important dates

Study start
2002
Study completion
2006
First posted
Oct 1, 2007
Registry last updated
Mar 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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