Severe limb ischemia Circulatory System
Conditions
Interventions
Patients will be randomized in a 1:1 ratio. The randomization procedure is stratified by the research department and the permuted block design within strata is utilized. The study treatment is randoml
Sponsors
Ministry of Science and Technology (Taiwan)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age between 20-80 with severe limb ischemia due to diffuse atherosclerosis. Inclusion criteria for the study were all of the following: 1. Ischemic peripheral vascular disease with rest pain defined as pain that occurs at night and at rest. Clinical evaluation by Fontaine classification (Fontaine stage III: rest pain, stage IV: ulcer and/or necrosis) 2. Ankle–brachial index (ABI)<0.7 3. A non-surgical candidate for revascularization, for example, diffuse multi-segment disease, inability to locate a suitable vein for grafting, or extensive infra-popliteal disease not amenable to a vascular graft 4. The image analysis includes the MRA or angiocardiography by diagnostic intravascular catheter (depended on clinical results). The above results show that obstruction more than 75% stenosis will considerate into this test 5. Use of contraception 6. The trialists accept the laboratory data within 3 months since initial screening 7. TcPO2<45mmHg
Exclusion criteria
Exclusion criteria: 1. Age 80 y/o 2. Pregnant or feeding women 3. Adventitious agents (HIV, syphilis, hepatitis B virus, hepatitis C virus, will be excluded. If the examination result is positive, Centers of Disease Control will be notified by law) 4. Infective disease 5. Myocardial infarction within 3 months, heart failure, or functional class IV 6. Malignant or hematologic disease, or severe disease with life span less than one year 7. End stage renal disease or eGFR less than 30 ml/min 8. Patients after treatment improved in the case using bypass surgery or stenting ischemic cardiac catheterization 9. Receiving other clinical trials monitor 10. Patients can’t receive therapy or examination in this study 11. Blood sugar and blood pressure control poorly (SBP>160 mmHg, AC F/S>200mg/dL and PC F/S>300mg/dL) 12. Not suitable for cardiac catheterization 13. Contraindications to G-CSF or HBO 14. Patient is unconscious 15. Untreated active infection 16. Those who undergo major surgery within one month 17. Patients with stroke or unstable angina within 3 months 18. Unsuitable candidates after initial evaluation 19. Those of unsuitable for HBO therapy, e.g., active pulmonary tuberculosis, spontaneous pneumothorax etc 20. TcOP2 =46mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Limb salvage, defined as alive without amputation within 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Relief of rest pain was measured using Canadian cardiovascular society grading of angina pectoris (CCS) score at 1 week, 1 month, 3, 6, 9 and 12 months after hospitalization or enrollment 2. Ankle brachial index (ABI) was measured by duplex echography at 1, 3, 6 and 12 months after hospitalization or enrollment 3. New collateral vessel formation measured by magnetic resonance angiography (MRA) at 6 and 12 months 4. The amount of O2 diffused from capillaries through the epidermis of diseased foot, measured using transcutaneous oximetry (TcPO2) at 6 and 12 months 5. Walking distance and cardiopulmonary function measured using six-minute walk test (if possible), and quality of life measured using Short Form-36 (SF-36) at 1, 3, 6 and 12 months after hospitalization or enrollment Safety endpoint: adverse events and severe adverse events (death or hospitalization) of study patients measured using case report form at clinical visit every three months or as necessary | — |
Countries
Taiwan
Contacts
Public ContactHon-Kan Yip
Outcome results
None listed