I70.22
Conditions
Interventions
Group 1: - Observation period after initiation of cilostazole therapy with a dosage of
2 × 100 mg / day over 12 months
- collection of the demographic master data, possible influencing companion disea
Sponsors
Universitätsklinik für Allgemein-, Viszeral- und Gefäßchirurgie
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: - the appropriate application of cilostazole therapy, - anamnestic, clinical, and Doppler sonography (3 months' consultation - consultations over a period of at least 6 months with anamnesis survey, including investigation of painless and maximal walking distance), clinical baseline examination of vascular status, Doppler sonography of the legs with determination of the ABI), - taking the recommended dose of cilostazole: 2 × 100 mg or 2 × 50 mg - a basic compliance.
Exclusion criteria
Exclusion criteria: - vascular surgery or radiological interventions of the lower extremity during the administration of cilostazole - "off label use" of Cilostazol, - the presence of a tumor, - severe renal impairment with a creatinine clearance <25 ml / min, - moderate or severe hepatic impairment, - the presence of a pregnancy, - history of ventricular tachycardia, ventricular fibrillation, multifocal ventricular ectopia, or prolongation of the QTc interval, - amputated limbs of the lower extremity or - degenerative joint diseases that do not allow walking distance determination or immobility, and finally - lack of basic compliance, especially when taking medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The standardized tread determined maximum walking distance / stretch extension after 3, 6, 9 and 12 months after medication initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination: - the quality of life through semiquantitative elevation of the tendency in subjective sensation, - the influence of secondary diseases, - the influence of parameters / factors, the ABI as a relevant therapeutic effect parameter, - the side-effect profile, The frequency of a dose reduction or a discontinuation of therapy as well as - of medically relevant adjuvant therapies All surveys were carried out after 3, 6, 9 and 12 months after medication initiation | — |
Countries
Germany
Contacts
Public ContactFrank Meyer
Universitätsklinik für Allgemein-, Viszeral- und Gefäßchirurgie
Outcome results
None listed