NCT04267640Unknown2 期
A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects Who Have Peripheral Ischemic Ulcers of the Lower Extremity
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 40
- 主要终点
- Complete ulcer healing at 6 months
研究概览
简要总结
This study will assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor [HGF] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease.
详细描述
This is a Phase 2, double-blind, randomized, placebo-controlled, parallel group study. Approximately 60 male or female subjects aged 18 years or older with one shallow foot ulcer and mild/moderate ischemia due to peripheral artery disease (PAD) will be randomized in a 1:1:1 ratio to one of 3 treatment groups:
- 4.0 mg AMG0001 intramuscular (IM) (n = 20)
- 8.0 mg AMG0001 IM (n = 20)
- Placebo IM (n = 20)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Documented diagnosis of PAD and mild/moderate foot ischemia (WIFI ischemia grades 1, 2)
- •A single measurable ulcer of ≥ 1 cm2 and ≤ 10 cm2 on a lower extremity without evidence of infection or gangrene and no evidence of bone and/or tendon involvement at randomization
- •Subjects will undergo protocol-defined standardized wound care during the screening period and through 12 months from the first dose of investigational product
- •Subjects who have a diagnosis of diabetes must be considered stable with no changes in diabetic medication regimen anticipated during the study period. Subjects who have a diagnosis of diabetes must have a HbA1c of ≤12% at Screening
排除标准
- •Subjects who have excessive tissue necrosis that is unlikely to benefit from medication, or those subjects who, in the opinion of the Investigator, are felt likely to require revascularization within 1 month of screening
- •Subjects with severe limb ischemia
- •Subjects who are considered likely to require a major amputation (at or above the ankle) within 3 months of screening
- •Subjects with deep ulcerations with bone or tendon exposure, or uncontrolled infection, or with the largest ulcer that is >10 cm2 in area
- •Subjects with hemodynamically significant aorto-iliac occlusive disease
- •Subjects who have had a technically successful revascularization by surgery or angioplasty within 2 months. If subjects are more than two months from revascularization and still meet the inclusion criteria, they may be considered for enrollment. Subjects who have had a technically unsuccessful attempt at revascularization may be enrolled at least one week from the procedure
- •Subjects currently receiving immunosuppressive medication, systematically administered steroid therapy, chemotherapy or radiation therapy. Inhaled and topical steroid therapies are allowed
结局指标
主要结局
Complete ulcer healing at 6 months
时间窗: Month 6
Complete ulcer healing defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart.
Time to complete ulcer healing
时间窗: Month 12
Complete ulcer healing defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart.
次要结局
- The percentage reduction of ulcer size from baseline(Months 4, 6, 8, 10, 12)
- Hemodynamic measurements of toe pressure (TP)(Months 4, 6, 8, 10, 12)
- Hemodynamic measurements of TcPO2(Months 4, 6, 8, 10, 12)
- Visual Analogue Scale (VAS)(Months 4, 6, 8, 10, 12)
- Hemodynamic measurements of ankle systolic pressure (ASP)(Months 4, 6, 8, 10, 12)
- Occurrence of New Ulcer of the Index leg(Months 4, 6, 8, 10, 12)
- Hemodynamic measurements of ankle brachial index (ABI)(Months 4, 6, 8, 10, 12)
- Hemodynamic measurements of toe brachial index (TBI)(Months 4, 6, 8, 10, 12)
- Major / Minor Amputations (digit, forefoot) / Revascularization of the Index Leg(Months 4, 6, 8, 10, 12)
研究者
研究点 (40)
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