A Prospective, Randomized, Double Blind Investigation of Amnios™ RT for the Treatment of Plantar Fasciitis
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Plantar Fasciitis
- 发起方
- Globus Medical Inc
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Serious Adverse Events
- 状态
- 已完成
- 最后更新
- 3年前
概览
简要总结
The purpose of this study is to evaluate clinical outcomes of patients with plantar fasciitis following treatment with Amnios™ RT. Patients will be randomized to either Amnios™ RT or a placebo control.
研究者
入排标准
入选标准
- •Confirmed diagnosis of unilateral plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months by the Investigator
- •VAS Foot Pain score of at least 45mm (out of 100mm scale) at randomization
- •Plantar fasciitis with conservative treatment for ≥ 1 month (30 days), including any of the following modalities:
- •Stretching exercises
- •Orthotics
- •Diagnostic radiograph within 6 months of enrollment showing view of calcaneus, without evidence of calcaneal fracture or structural abnormalities
- •BMI ≤ 40 kg/m2
- •Age ≥ 18 years and \< 80 years
- •Willing and able to comply with the follow-up requirements of the protocol
- •Signed an Informed Consent Form specific to this research and agreed to release of medical information
排除标准
- •Prior surgery or trauma resulting in severe, permanent damage to the affected foot
- •Require bilateral plantar fasciitis treatment at time of enrollment (with exception of compensatory symptoms on the non-affected foot)
- •Prior use of any lower limb injection therapy, including corticosteroids or PRP in either foot within the last 3 months
- •Has Type I or Type II diabetes mellitus
- •Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, reactive arthritis, rheumatoid arthritis, etc.
- •The presence of diagnosed comorbidities that can be confused with or can exacerbate the condition (as assessed by radiograph) including:
- •Calcaneal stress fracture
- •Nerve entrapment syndrome (diagnosed as Baxter Nerve Syndrome)
- •Fat pad atrophy (relative to expectations for patient's age)
- •Acute traumatic rupture of the plantar fascia
结局指标
主要结局
Serious Adverse Events
时间窗: 12 Months
The occurrence of serious adverse events that are related to the product.
Visual Analog Scale (VAS) Foot Pain Score
时间窗: 3 Months
The visual analog scale (VAS) is a patient questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "most intense pain imaginable" on the right border. The subject is instructed to place a vertical line on the scale that indicates the pain severity experienced; 0mm is equal to no pain and 100mm is most intense pain imaginable. Study staff records the distance of the patient's mark on the scale in millimeters.