Introduction: Intermittent claudication has a significant negative impact on the patients'
quality of life. Revascularization procedures and noninvasive medical therapies can
improve walking capacity. Cilostazol has IA recommendation for the treatment of intermittent
claudication. Aim: The aim of this study was to evaluate the effect of a three-month
cilostazol treatment on the health-related quality of life and on the lower-limb functional
capacity in diabetic (DM) and non-diabetic patients (NDM) with intermittent claudication
in the clinical practice. Method: The study was a multicenter, non-interventional
trial; 812 patients with peripheral artery disease (Fontaine II stage, mean age: 67.17
years, male/female: 58.25/41.75%, 318 diabetics) were enrolled, who received cilostazol
(50 or 100 mg twice a day) for 3 months. The quality of life was evaluated with the
EQ-5D-3L questionnaire, the functional capacity with the WELCH questionnaire. Walking
distances, ankle-brachial index were measured at baseline and after 3 months. Results:
Upon conclusion of the study, the EQ-5D index improved both in non-diabetic and diabetic
patients (baseline: NDM -0.45 +/- 0.22, DM -0.48 +/- 0.23, 3rd month: -0,24 +/- 0.18,
-0,27 +/- 0.19; respectively; p<0.0001) and there was a significant increase in the
WELCH score as well (baseline: NDM 20 +/- 14, DM 18 +/- 14; 3rd month: 33 +/- 19,
29 +/- 16, respectively; p<0.0001). Both pain-free and maximal walking distance increased
by 59.2% (median: 50.0%), 46.58 (median: 40.51%) in NDM and 42.85% (median: 43.33%),
41.61% (median: 34.68%) in DM patients, respectively (p<0.001). Conclusions: Three
months of cilostazol treatment improved the quality of life and lower-limb functional
capacity in diabetic and non-diabetic claudicant patients. The WELCH questionnaire
is a useful tool in clinical practice for the evaluation of intermittent claudication
treatment.