Peripheral Vascular Disease Clinical Trial
Official title:
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of NL003 in Subject With Critical Limb Ischemia(Rutherford 5)
Verified date | June 2024 |
Source | Beijing Northland Biotech. Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate whether intramuscular injections of NL003 into the calf is safe and effective in the treatment of critical limb ischemia
Status | Completed |
Enrollment | 242 |
Est. completion date | December 23, 2023 |
Est. primary completion date | December 23, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | Inclusion Criteria: - 1. At the age of 20 and 80 (at the time of signing the informed consent), both male and female. 2. According to DSA or CTA, patients diagnosed with lower limb arterial ischemic disease based on the medical history and clinical manifestations and with Rutherford grade 5 (with ulcer) must meet the substandardProspective.(if both limbs of the subject suffer from lower limb arterial ischemic disease, it is up to the investigator to select one limb for the study.)Resting ankle systolic pressure (dorsal foot artery or posterior tibial artery) =70mmHg or ABI=0.5 or TcPO2 < 30mmHg;In the first 3 months after randomized inclusion, DSA or CTA confirmed severe stenosis (=70%) or occlusion of superficial femoral artery or popliteal artery or inferior knee artery. 3. Patients with chronic lower limb arterial ischemia complicated with ulceration also met the following requirements: when signing the informed consent, the ischemic ulcer of the artery lasted at least 2 weeks;When signing the informed consent, the area of a single ulcer is no more than 10cm2;If there are multiple ulcers in the affected limb selected at the time of signing the informed consent, the total number of ulcers shall not exceed 3.Basic ulcer care (according to standard ulcer care procedure) should be maintained during the test to avoid aggravation of infection.The ulcer did not expose bone or joint capsule.If there is gangrene, only partial toe gangrene. 4. Agreed to use the basic treatment drugs as required during the test, and kept a complete record of the subjects' diaries on time. The compliance of the basic treatment drugs and the subjects' diaries during the screening period was =70%. 5. Agree to use appropriate contraceptive measures during the experiment;Female subjects of reproductive age, blood pregnancy test negative. 6. Signed informed consent. Exclusion Criteria: - 1. Patients with acute lower limb ischemia or acute exacerbation of chronic lower limb ischemia. 2. Vascular reconstruction (bypass or intravascular therapy) or sympathetic resection or amputation was performed within 4 weeks prior to the signing of the informed consent. 3. Due to the surgical operation, the patient was still in the postoperative risk period, and the researcher judged that it was not suitable for the participant. 4. Main-iliac artery stenosis =70%. 5. Severe limb infection (cellulitis, osteomyelitis, etc.), distal fascia or bone exposure were observed. 6. Cardiac function NYHA class belongs to ? grading standards (see appendix 1). 7. Cerebral infarction, cerebral hemorrhage, myocardial infarction or unstable angina pectoris occurred within 3 months before signing the informed consent. 8. Refractory hypertension (systolic blood pressure =180mmHg or diastolic blood pressure =110mmHg when taking three or more antihypertensive drugs). 9. Proliferative retinopathy and retinopathy examination is not available. 10. Inability to accurately describe symptoms and emotions. 11. Severe liver disease with uncompensated cirrhosis, jaundice, ascites or hemorrhagic varices. 12. Current recipients of immunosuppressants or chemoradiotherapy. 13. Anti-hiv antibody positive, anti-hepatitis c antibody positive and hepatitis b surface antigen positive (if the subject is HBsAg positive and HBV DNA in peripheral blood is combined, the researcher believes that the subject's chronic hepatitis b is stable and will not increase the risk of the subject, the subject can be selected). 14. Results of laboratory examination during screening period: hemoglobin < 80g/L, white blood cell count < 3.0×109/L, platelet < 75×109/L, upper limit of normal AST or ALT >, upper limit of normal serum creatinine > was 3 times, or other laboratory examination indicators showed abnormalities that researchers thought might affect the evaluation of test results. 15. Poor blood glucose control after treatment (glycosylated hemoglobin > 10%). 16. Previously diagnosed with malignant tumor, or any of the following test results determined by the investigator to be at risk of tumor: fecal occult blood test;Chest X-ray examination or chest CT examination;Alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA) and ca19-9;Male subjects, prostate specific antigen test (PSA, free PSA);Female subjects: cervical smear (Pap), mammography/b-ultrasound, ca-125;The investigators determined that additional tests were necessary to eliminate the tumor risk. 17. In the opinion of the investigators, patients with comorbidities that affect safety and efficacy evaluation, or those with a predicted survival of less than 12 months. 18. Frequent drinkers within the 12 months prior to the signing of the informed consent, i.e., those who drank more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL alcohol of 40% spirits or 150 mL wine) or substance abusers. 19. Participate in other clinical trials within 3 months before signing the informed consent. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Hospitai | Beijing | Beijing |
China | Peking Union Medical College Hospital | Beijing | Beijing |
China | The Second Xiangya Hospital of Central South University | Changsha | Hunan |
China | The Third Xiangya Hospital of Central South University | Changsha | Hunan |
China | Chifeng Municipal Hospital | Chifeng | Neimenggu |
China | The Ninth People's Hospital of Chongqing | Chongqing | Chongqing |
China | The Affiliated Hospital of Qingdao University | Qingdao | Shandong |
China | Shanghai seventh people's hospital | Shanghai | Shanghai |
China | Shanxi Provincial People's Hospital | Taiyuan | Shanxi |
China | First Affiliated Hospital of Xi 'an Jiaotong University | XiAn | Shanxi |
China | Second Affiliated Hospital of Xi 'an Jiaotong University | XiAn | Shanxi |
China | Xuzhou Mining Group General Hospital | Xuzhou | Jiangsu |
China | Zhangzhou Municipal Hospital of Fujian Province | Zhangzhou | Fujian |
Lead Sponsor | Collaborator |
---|---|
Beijing Northland Biotech. Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of ulcer complete healing | 1.At D180 visit, subjects intended to observe the healing of all arterial ischemic ulcers in the limb;2.Ulcer healing criteria: skin epidermal cell regeneration without secretion. | Day180 | |
Secondary | The time when the ulcer finally heals completely | The time between the first use of the study drug and the final full healing of the ulcer. | Day14,Day28,Day60,Day90,Day120,Day180 | |
Secondary | Percentage of cases with ulcer area reduced by =50% from baseline | The ulcer area at the last visit was 50% less than the baseline case percentage. | Day180 | |
Secondary | Percentage of new ulcer or gangrene cases | The percentage of new ulcer or gangrene cases after use of the study drug. | Day14,Day28,Day60,Day90,Day120,Day180 | |
Secondary | Rate of complete disappearance of pain | Rate of complete disappearance of pain. | Day180 | |
Secondary | Percentage of cases with a 50% reduction in pain score from baseline | A 50% reduction in pain score from baseline at the last visit. | Day180 | |
Secondary | Changes in pain score from baseline | The severity of critical Limb ischemia was assessed by Rutherford grading at screening, D14, D28, D60, D90, and D180, respectively. | Day14,Day28,Day60,Day90,Day120,Day180 | |
Secondary | Changes in quality of life scores from baseline | The quality of life score questionnaire was conducted to evaluate the subjective perception of Critical Limb Ischemia, including the subjects' perception of quality of life, health, or other aspects of life. | Day14,Day28,Day60,Day90,Day120,Day180 | |
Secondary | Changes in Rutherford grading from baseline | The severity of critical Limb ischemia was assessed by Rutherford grading at screening, D14, D28, D60, D90, and D180, respectively. | Day14,Day28,Day60,Day90,Day120,Day180 | |
Secondary | Changes to the ABI from the baseline | Ankle-brachial index (ABI) refers to the ratio of systolic blood pressure of the anterior tibial artery (dorsal foot artery) or posterior tibial artery to the systolic blood pressure of the brachial artery.Participants were tested for ankle-brachial index (ABI). | Day60,Day90,Day120,Day180 | |
Secondary | The percentage of patients who undergo revascularization (open surgery or interventional therapy) has a high amputation rate of mortality | The percentage of patients who undergo revascularization (open surgery or interventional therapy) has a high amputation rate of mortality. | Day180 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05335525 -
Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)
|
||
Active, not recruiting |
NCT01903044 -
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating
|
Phase 1/Phase 2 | |
Completed |
NCT02228564 -
BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease
|
N/A | |
Completed |
NCT02271529 -
Zilver PTX Delivery System
|
N/A | |
Recruiting |
NCT02054871 -
RCT to Evaluate the Renal Protective Effects of Remote Ischaemic Preconditioning in Peripheral Angioplasty
|
N/A | |
Completed |
NCT00822172 -
Evaluation of Cilostazol in Combination With L-Carnitine
|
Phase 4 | |
Completed |
NCT00574782 -
Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE)
|
N/A | |
Completed |
NCT00029991 -
Extract of Ginkgo Biloba (EGB 761) and Vascular Function
|
Phase 1/Phase 2 | |
Completed |
NCT01355406 -
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System
|
N/A | |
Recruiting |
NCT05804097 -
Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?
|
Phase 4 | |
Recruiting |
NCT03638115 -
The VaSecure BTK Study
|
N/A | |
Active, not recruiting |
NCT03241459 -
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon
|
N/A | |
Active, not recruiting |
NCT01661231 -
Study to Determine the Performance of the Astron and Pulsar-18 Stents in Europe
|
N/A | |
Completed |
NCT01722877 -
JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions
|
N/A | |
Completed |
NCT01444378 -
Absolute Pro® MOMENTUM™
|
N/A | |
Completed |
NCT00753337 -
The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study
|
N/A | |
Completed |
NCT00593385 -
Atrium iCAST Iliac Stent Pivotal Study
|
N/A | |
Completed |
NCT00538226 -
Evaluation of the Effect of the Flowaid Device in Increasing Local Circulation in the Leg
|
Phase 1 | |
Recruiting |
NCT00385385 -
RESTORE-IT-Study of Rifalazil in Chlamydia Pneumoniae Seropositive Patients With a History of Atherosclerotic Disease
|
Phase 2 | |
Completed |
NCT00392509 -
ALD-301 for Critical Limb Ischemia, Randomized Trial
|
Phase 1/Phase 2 |