Prospective, Systematic Observational Study on the Daily Use of Cilostazol (Pletal®) in Clinical Vascular Surgical Practice – Significant Improvement of Walking Distance and Quality of Life for Patients with PAOD, Stage II b

• Conditions: I70.22

• Registration Number: DRKS00011235
• Lead Sponsor: niversitätsklinik für Allgemein-, Viszeral- und Gefäßchirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2012-06-29
• Study Start: 2016-12-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 146

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

- 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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The standardized tread determined maximum walking distance / stretch extension after 3, 6, 9 and 12 months after medication initiation

Secondary Outcome Measures

Name	Time	Method
Determination:<br>- the quality of life through semiquantitative elevation of the tendency in subjective sensation,<br>- the influence of secondary diseases,<br>- the influence of parameters / factors, the ABI as a relevant therapeutic effect parameter,<br>- the side-effect profile,<br>The frequency of a dose reduction or a discontinuation of therapy as well as<br>- of medically relevant adjuvant therapies<br><br>All surveys were carried out after 3, 6, 9 and 12 months after medication initiation