NCT05426161已完成4 期
The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities, a Prospective Exploratory Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Proportion of patients reaching a reduction in mean visual analog scale (VAS) > 20 mm (at rest) in dynamic pain scores at study day 21 or 41
研究概览
简要总结
The aim of the study is to investigate the effect of subcutaneous administration of Botulinum toxin A on wound pain, wound healing and safety of treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •Lower extremity ulcer ≥ 4 weeks.
- •Ulcer area ≥ 1,5 cm2 and ≤ 20 cm2
- •Patients with neuropathic pain related to the ulcer (daily VAS pain scores ≥ 30 mm at rest and DN4 score ≥ 4).
- •Normal monofilament and vibration test in lower extremities.
- •Patients who can fill out pain diary correctly.
- •Written informed consent to participate in the study after having fully understood the contents of the protocol and restrictions.
排除标准
- •Infection at injection site.
- •Hypersensitivity to botulinum toxin A.
- •Peripheral neuropathy.
- •Diabetic foot ulcer.
- •Unstable critic peripheral ischemia judged by investigator
- •Exposed capsule, tendon, muscle or bone in the ulcers.
- •Tunnelling, undermining or sinus tracts.
- •Disorders of the neuromuscular junction (e.g. Myasthenia).
- •Topical analgesic (e.g Biatain ibu or Lidocain) within 7 days before inclusion.
- •Pregnant or lactating woman and woman with childbearing potential but does not use contraception.
- •Judgment by the investigator that the patient is not suited for study participation.
研究组 & 干预措施
Botulinum Toxin A
Experimental
Open-label study
干预措施: Botulinum Toxin A (Drug)
结局指标
主要结局
Proportion of patients reaching a reduction in mean visual analog scale (VAS) > 20 mm (at rest) in dynamic pain scores at study day 21 or 41
时间窗: 3 to 6 weeks after first injection of Botulinum toxin a
At study day 0 the mean VAS will be calculated at rest for D-2-0 and at D21 or D41 mean VAS will be calculated for D19-21 or D39-41
次要结局
- Absolute and percentage change of the ulcer area.(Throughout the trial (12-15 weeks))
- Therapeutic doses of Botulinum toxin a to treat wound pain(3 and 6 weeks after first injection)
- Clinical improvement of the wound healing process(Throughout the trial (12-15 weeks))
- Exploratory measurement: Changes in the levels of cytokines and pain related substances in the wound fluid before and after injection with Botulinum toxin a(Analysis within 1 year after study completion)
- Absolute and percentage change in the area of hyperalgesia and allodynia(3 to15 weeks after first injection of Botulinum toxin a.)
- Incidence of Treatment-Emergent Adverse Events(Throughout the trial (12-15 weeks))
研究者
Lubna Sabah, MD
Prinicipal Investigator, MD
Bispebjerg Hospital
研究点 (1)
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