NCT03414268已完成3 期
A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Plantar Fasciitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 16
- 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 the saline placebo injection in the treatment of plantar fasciitis
详细描述
Approximately 276 patients will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 6-month observation period. Randomization will be 1:1. The study is expected to be completed within 34 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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator
- •VAS Pain scale of ≥ 45 mm at randomization
- •Plantar fasciitis with conservative treatment for ≥ 1 month (30 days), including any of the following modalities:
- •Stretching exercises
- •Orthotics
- •Diagnostic X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities
- •BMI ≤ 40 kg/m2
- •Age ≥ 21 years and < 80 years
- •Ability to sign Informed Consent and Release of Medical Information Forms
- •Ability to receive and respond to text messages or emails on a daily basis.
排除标准
- •Prior surgery or trauma to the affected site
- •Subjects requiring bilateral plantar fasciitis treatment at time of enrollment
- •Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months
- •Has diabetes either Type I or Type II.
- •Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.
- •The presence of diagnosed comorbidities that can be confused with or can exacerbate the condition- to be assessed by X-ray - including but not limited to:
- •Calcaneal stress fracture
- •Nerve entrapment syndrome (diagnosed as Baxter Nerve Syndrome)
- •Fat pad atrophy
- •Acute traumatic rupture of the plantar fascia
- •Calcaneal tumor
- •Tarsal tunnel syndrome (diagnosed)
- •Significant bone deformity of the foot that may interfere with the study
- •Affected site exhibits clinical signs and symptoms of infection
- •Known allergy or known sensitivity to Aminoglycosides
- •Subjects who are non-ambulatory
- •History of more than 14 days treatment with immuno-suppressants (including systemic corticosteroids) or cytotoxic chemotherapy within 30 days prior to enrollment, or who are anticipated to require such medications during the course of the study
- •Prior radiation at the site
- •Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment
- •Immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)
- •History of any condition (including drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol, in the judgment of the investigator
- •Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
- •Workers' compensation subjects
研究组 & 干预措施
Micronized dHACM
Experimental
1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)
干预措施: Micronized dHACM (Other)
Saline Injection
Placebo Comparator
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: 180 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 for Pain:
次要结局
- Foot Function Index - Revised (FFI-R) (Short Form)(90 Days)
研究者
研究点 (16)
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