A Phase II Clinical Trial Evaluating the Safety and Effect of abobotulinumtoxinA Injection in the Gastrocnemius Muscle to Improve Equinus and Associated Plantar Fasciitis Pain
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- injection
研究概览
简要总结
The purpose of this research is to collect safety and efficacy data on injection of botulinumtoxinA (AbobotulinumtoxinA /Dysort) into the gastrocnemius (calf) muscle to improve equinus (lack of flexibility to bring the top of the foot towards the front of the leg) in subjects with plantar fasciitis and relieve pain associated with this condition. The use of AbobotulinumtoxinA is considered experimental in this study because it has not been approved by the United States Food and Drug Administration (FDA) for the treatment of plantar fasciitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old and not older than 75 years.
- •History of Plantar fasciitis for a minimum of 6 weeks
- •History and physical examination consistent with plantar fasciitis and a diagnostic ultrasound study showing thickening of the plantar fascia >5 mm (normal is 3 mm)
- •Minimum Visual Analog Scale (VAS) score of
- •Failed conservative care with at least two of the following treatments: Stretching, rest, shoe modifications, insoles or orthotics, physical therapy, or cortisone injection.
- •Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
- •Subject understands and is willing to participate in the clinical study and can comply with visit and post -injection questionnaire schedules.
排除标准
- •Patients with history of diabetes, back issues, nerve issues or previous surgery of the foot or calf.
- •Patients with no pain in the heel region.
- •Subject is pregnant or breast- feeding.
研究组 & 干预措施
Single group
Single group
干预措施: AbobotulinumtoxinA 300 UNT (Drug)
结局指标
主要结局
injection
时间窗: 8 weeks
Reduction of pain (VAS scale) associated with plantar fasciitis at 8 weeks post injection
次要结局
- Adverse Events(26 weeks)
- PROMIS Pain intensity instrument(26 weeks)
- PROMIS Pain interference instrument(26 weeks)
- PROMIS Physical function Instrument(26 weeks)
- AOFAS Ankle-Hindfoot Score(26 weeks)
- FAAM Foot and Ankle Ability Measure(26 weeks)
- Gastrocnemius measurement(26 weeks)
- Gastrocnemius measurement and mobility(26 weeks)
研究者
Maha K. Curley
Study Coordinator
University Foot and Ankle Foundation