PAD patients with severe intermittent claudication graded as Fontaine IIb and III
Conditions
Interventions
Placebo (0ciu/leg)
Low dose (1x10e9 ciu/leg)
High dose (5x10e9 ciu/leg)
Sponsors
Kyushu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Meet criteria (1) to (5) below and are confirmed as such by at least 1 specialist qualified by the Japanese Society for Cardiovascular Surgery and at least 1 specialist qualified by the Japanese Association of Cardiovascular Intervention and Therapeutics. (1) arteriosclerosis obliterans with stable symptoms, have intermittent claudication (ACD < 200 m) and are able to walk on a treadmill (2) resting ABI < 0.9 (3) refuse revascularization, risk of revascularization may be greater than the benefit, or develop obliteration after revascularization (4) angiographic findings show patency from the abdominal aorta through to the proximal side of the external iliac artery (5) angiographic findings meet the above criterion (4), and have stenosis or obliteration under the femoropopliteal region with morphology defined as type C or D based on TASCII 2) Administering cilostazol for at least 1 month and meet criterion 1). 3) Aged 40 years to 80 years. 4) Either sex, either inpatients or outpatients. 5) Able to give written consent for themselves.
Exclusion criteria
Exclusion criteria: 1) Have ischemic ulcer 2) Diagnosed with Buerger's disease 3) Have a current or past history of life-threatening allergies 4) Have been shown or are suspected to have cancer 5) With concurrent proliferative intraocular neovascularization 6) With concurrent cardiac failure (NYHA class II-IV) 7) With untreated severe arrhythmia 8) Have or are suspected to have interstitial pneumonia 9) Have progressive hepatic disorders 10) Have moderate or severe hepatic disorders (1) AST or ALT >2.5 times the upper limit (2) Prothrombin time is 14 seconds or longer (3) Serum bilirubin >2.0 times the upper limit 11) Diagnosed with hepatic cirrhosis (classified as B or C on the Child-Pugh) 12) Have an inflammatory disease 13) Treated with immunosuppressants or corticosteroids for the treatment of various inflammatory diseases or after organ transplantation 14) Underwent extirpative surgery of a malignant tumor in the past 5 years 15) Have had a cerebral hemorrhage or cerebral infarction in the past 6 months 16) With blood diseases 17) With moderate or severe renal dysfunction (CCr < 40 mL/min) 18) With alcohol or drug dependence 19) Pregnant/lactating female, or who wish or are suspected to be pregnant 20) Positive HIV antibodies 21) Took part in any other clinical studies or research in the past 30 days 22) Not permitted to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Rate of increase in absolute claudication distance (ACD) - ACD - Peak walking time - Initial claudication distance (ICD) - Claudication onset time | — |
Secondary
| Measure | Time frame |
|---|---|
| - Measurement of oxygen dynamics in the leg muscles by near infrared spectroscopy after a treadmill load test - Proportion of subjects in whom readministration was not required - Evaluation of QOL based on the Walking Impairment Questionnaire (WIQ) - Time-course changes using clinical stage classifications (Fontaine classification, Rutherford classification) - Ankle-brachial pressure index - Toe-brachial pressure index - Time-course changes in pain at rest evaluated by the visual analogue scale - Time-course changes in pain at rest evaluated by the frequency of analgesic use - Incidence of cardiovascular events (to be followed up to 5 years after administration) | — |
Countries
Japan
Contacts
Public ContactTakuya Matsumoto
Kyushu University Hospital Vascular Surgery
Outcome results
None listed