Safety and Efficacy Study of Urokinase for the Treatment of Diabetic Foot Syndrome and Critical Limb Ischemia (August2)

GWT-TUD

Status and phase: Terminated; Phase 3

Conditions: Diabetic Foot; Critical Limb Ischemia

Treatments: Drug: urokinase

Study type: Interventional

Funder types: Other

Identifiers

NCT01638585

August 2

2010-023426-20 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

standard therapy

No Intervention group

Description:

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 group

Description:

patients receiving urokinase short infusions in addition to standard therapy

Treatment:

Drug: urokinase