A Phase 2B Randomized Double Blind Placebo Controlled Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Direct Intramuscular Injection as Adjunct to Revascularization of Infrapopliteal Lesions in Subjects With Advanced Peripheral Artery Disease and Tissue Loss
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 24
- 主要终点
- The composite is designed to quantify clinically significant improvement or worsening over baseline by assigning a score to each patient that represents their overall outcome.
研究概览
简要总结
To investigate the efficacy of the administration of JVS-100 delivered via direct intramuscular injections on a 3 month and 6 month composite endpoint of wound progression, healing and limb loss in patients with severe peripheral arterial disease with non-healing chronic wounds who undergo an open bypass grafting or endovascular procedure for treatment of infrapopliteal disease and are dosed within 12 days and 3 months following the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major Inclusion Criteria:
- •Currently receiving standard of care wound treatment (>2 weeks) for chronic wounds or gangrene including as indicated: debridement, pressure offloading, infection control, and/or maintenance of a moist wound environment.
- •Diagnosis of advanced PAD with tissue loss (ulceration and/or dry gangrene) on the foot of the index leg with an ulcer size of at least 0.5 cm2 and <25 cm
- •Index wounds on the heel must be <10 cm2 that cannot be probed to bone, have exposed bone or osteomyelitis.
- •Post revascularization intervention inclusion criteria include an attempt at open bypass grafting or endovascular intervention of a popliteal/infrapopliteal lesion(s) on the same leg that has tissue loss without significant improvement in TBI post intervention. The following will be accepted as demonstrating a lack of post intervention toe brachial index (TBI) improvement:
- •TBI ≤ 0.51or;
- •Toe pressure ≤50 mmHg with flat or dampened wave forms or;
- •Skin Perfusion pressure ≤40 mmHg at mid foot level or;
- •TcPO2 ≤40 mmHg
- •Subjects willing to forgo treatment with hyperbaric oxygen, nerve stimulation or sympathectomy for the treatment of advanced PAD from time of consent to 6 months following the initial injection of study drug
排除标准
- •Previous major amputation of the leg to be treated or planned major amputation or transmetatarsal amputation within the first month following enrollment.
- •Only a short segment superficial femoral artery lesion - consistent with Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) A or B category, and no infrapopliteal disease
- •Staged or planned intervention in the index leg within 30 days after the index procedure
- •Acute limb-threatening ischemia, trauma, known non-atherosclerotic vascular disease
- •Non-salvageable limb defined as major tissue loss and an unsalvageable foot;
- •Wounds that have decreased in size by >50% between the Screening visit and Day
- •If patient has active infection of the index limb that is being treated, and, in the opinion of treating physician, will not lead to an amputation within the next 3 months, the patient can be enrolled.
- •Inability to safely perform a revascularization procedure due to uncontrolled diabetes or other medical condition.
- •Presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial
研究组 & 干预措施
8 mg placebo
Biological/Vaccine: Placebo Injection Intramuscular Injection
干预措施: Placebo (Biological)
16 mg placebo
Biological/Vaccine: Placebo Injection Intramuscular Injection
干预措施: Placebo (Biological)
16 mg JVS-100
Biological/Vaccine: JVS-100 Injection Intramuscular Injection
干预措施: JVS-100 (Biological)
8 mg JVS-100
Biological/Vaccine: JVS-100 Injection Intramuscular Injection
干预措施: JVS-100 (Biological)
结局指标
主要结局
The composite is designed to quantify clinically significant improvement or worsening over baseline by assigning a score to each patient that represents their overall outcome.
时间窗: 6 months
Change from baseline in the composite endpoint at 6 months in all treated (or one JVS-100 dose group) compared to all placebo.
The composite is designed to quantify clinically significant improvement or worsening over baseline by assigning a score to each patient that represents their overall outcome.
时间窗: 3 months
Change from baseline in the composite endpoint at 3 months in all treated (or one JVS-100 dose group) compared to all placebo.
次要结局
未报告次要终点