Critical Limb Ischemia
Conditions
Interventions
Group 2:placebo
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years male or female; 2. Subjects with PAD of a lower limb classified as Rutherford 4 or Rutherford 5, including arteriosclerosis obliterans(ASO), thromboangiitis obliterans(TAO), and who have: Distal extremity pain at rest, Ankle systolic pressure of <60 mmHg or Toe systolic pressure <40 mmHg, or Ankle Brachial Index(ABI)<0.50; 3. Whose superficial femoral arteries(femoral artery below the branch of profunda femorisartery), popliteal artery and below popliteal artery have one or more arterial stenosis(stenosis=75%), or have arterial occlusion, diagnosed by DSA, CTA or MRA, 1 month prior to entering the study; 4. With an agreement of basic drug therapy in the study; 5. lower limb rest pain history of 2 weeks and 4=NRS score =7 (If analgesics are in use, The NRS will be assessed 5 times of T1/2 after stop taking analgesics); 6. Patients who have ulcers could maintain wound care and treatment. 7. Normal /have no significant results of following tumor examinations: fecal occult blood test (FOBT); breast X ray/ CT, abdomen Bultrasonography/CT; tumor marker: Alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), CA19-9, prostate specific antigen test (PSA) (male subjects only), CA-125 (female subjects only); If female, TCT, Molybdenum target X ray (results of 3months prior to screening can be accepted); 8. If female, negative pregnancy test of the subjects with child bearing potential, post-menopausal or surgically sterile history of 1 year; 9. Subjects should have good compliance on the requirements of the protocol, accept diet control, drug therapy, and signed an informed consent form directly or through a legally authorized representative or immediate family.
Exclusion criteria
Exclusion criteria: 1. acute PAD within 6 months, or acute advanced PAD, or local/diffuse gangrene; 2. patients who may take an amputation or revascularization or sympathectomy within 4 weeks or patients who have taken a revascularization or sympathectomy more than 4 weeks, but experiencing an unstable condition; 3. Main - iliac artery stenosis =75%; 4. Laboratory examinations below: Hemoglobin (HGB) 2 × ULN, total bilirubin (TBIL)> 2 × ULN; Creatinine (Cr)> 1.2 × ULN; Other abnormal laboratory examinations that likely to affect the evaluation of the study results judged by investigator; 5. Poor blood glucose control(Glycosylated hemoglobin (HbAlc)> 7.0%or GLU>7.0mmol/L); 6. Proliferative retinopathy and cannot take the retinopathy examination, or had an ophthalmic surgery within 3 months; 7. Severe liver disease with decompensated cirrhosis, jaundice, ascites, or hemorrhagic varicose veins; 8. heart failure patients, cardiac function classification NYHA belongs to grade III or IV; 9. within 3 months, patients with cerebral infarction, cerebral hemorrhage, myocardial infarction, unstable angina; 10. Malignant tumor patients, or abnormal tumor examinations in screening; 11. Patients with immunosuppressive agents, hemodialysis, tumor chemotherapy and radiotherapy; 12. Hypertensive patients with antihypertensive drugs: systolic blood pressure> 160mmHg or diastolic blood pressure> 100mmHg; 13. patients with positive Anti-HIV antibody, positive anti-hepatitis C antibody, hepatitis B [HBsAg(+) , Quantitative HBV DNA >1×10^3 IU/mL; 14. the aim limb with severe infections (such as cellulitis, osteomyelitis, etc.), distal fascia or bone exposure 15. in the study, the following drugs or dosage received more than the provisions below, However, before the washing of the group according to a predetermined dose or discontinuation except as adjusted to a predetermined dose: COX-2 inhibitors (eg, nimesulide); Aspirin(more than 100mg/day); high-dose steroids, except inhaled steroids; long-term use of opioid alkaloid analgesics (such as morphine); 16. disease combination may affect the efficacy evaluation and safety examinations; 17. within 12 months, a history of drug abuse or alcohol abuse; 18. Expected survival period is less than 6 months; 19. Within 3 months, participated in other clinical studies; 20. Those who cannot comply with the study protocol; 21. investigators judged that the subject have a potential risk or have any other factors may affect the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| D180 pain completely healing rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of ABI;Quality -of-Life questionnaire;Ratio of amputation;Percentage of patients with 50% reduction in pain NRS score;Usage of analgesic drug;Ratio of death;D180 ulcers completely healing rate;Percentage of patients with 50% reduction in ulcer area; | — |
Countries
China
Contacts
Public ContactYongquan-Gu
Xuanwu Hospital Capital Medical University
Outcome results
None listed