
    recruitment rate is unexpectedly too low (insufficient number of eligible patients).
  
['diabetes', 'peripheral arterial disease']
['dlbs1033', 'placebo']

        Inclusion Criteria:

          -  Signed informed consent before any trial related activities.

          -  Male or female subjects of 40 - 65 years of age.

          -  Diagnosis of diabetes mellitus defined as HbA1c level of ≥ 6.5% (for newly diagnosed
             diabetes) or based on medical history.

          -  Presence of peripheral arterial disease with resting ankle-brachial index (ABI) of
             0.41-0.90 inclusive

        Exclusion Criteria:

          -  Females of childbearing potential: pregnancy, breast-feeding, and the intention of
             becoming pregnant.

          -  Recent stroke attack, myocardial infarction/unstable angina/acute coronary syndrome,
             coronary artery bypass surgery (CABG) or percutaneous transluminal coronary
             angioplasty (PTCA)/stent within 3 (three) months prior to screening.

          -  Impaired liver function: serum ALT > 2.5 times upper limit of normal.

          -  Impaired renal function: serum creatinine ≥ 1.5 times upper limit of normal.

          -  Concomitant use of other antithrombosis drugs or any antiplatelets other than the
             study medication.

          -  Subjects with concurrent herbal (alternative) medicines or food supplements

          -  Subjects with any other disease state, including chronic or acute systemic infections,
             uncontrolled illnesses or other chronic diseases, which judged by the investigator,
             could interfere with trial participation or trial evaluation.

          -  Subjects with high risk of bleeding:

          -  Subjects with prior experience with DLBS1033 or other oral lumbrokinase products.

          -  Subjects with known or suspected allergy to any of study medications used in the
             study, including other lumbrokinase products.

          -  Subjects with known or suspected allergy or resistant to aspirin.
      