A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial Of The Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Achilles Tendonitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 14
- 主要终点
- Incidence of adverse events
研究概览
简要总结
Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis
详细描述
Approximately 158 subjects will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 12 month observation period. Randomization will be 1:1. The study is expected to be completed in 24 months, inclusive of enrollment and follow-up of all subjects.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Micronized DHACM
1mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM)
干预措施: Micronized DHACM (Biological)
Saline Injection
Injection of 1mL 0.9% Sodium Chloride Injection, USP
干预措施: Saline Injection (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: 365 days
The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection
Change in VAS score
时间窗: 90 days
Visual Analog Scale, Left end point is "No Pain". Right end point is "worst pain imaginable"
次要结局
- Foot Function Index Revised (FFI-R) (Short Form)(90 days)