NCT02131363已完成不适用
A Clinical Investigation to Evaluate the Safety and Performance of a Treatment Kit for Ingrowing Toenail
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- The proportion of subjects who demonstrate a reduction in the severity of their ingrowing toenail
研究概览
简要总结
This purpose of this study is to evaluate the safety and performance of a treatment kit for ingrowing toenail, primarily by determining the number of subjects who show a reduction in the severity of their ingrowing toenail.
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
- •Subjects with one great ingrowing toenail that is rated as either "slightly ingrowing", "somewhat ingrowing" or "very ingrowing" on the Investigators Ingrowing Toenail Severity Scale.
- •Subjects whose worst pain experienced in the week preceding inclusion, is rated at least 3 on the 10 point Subject Pain Intensity Scale.
- •Subjects whose affected toenail has a minimum of 2mm distal edge and a minimum nail width of at least 16mm.
排除标准
- •Subjects with any other toenail pathology (including pincer and spicule toenail) that would compromise the fitting of the toenail clip, or its use.
- •Subjects suspected to be immunocompromised.
- •Subjects who suffer from impaired feeling in the feet due to diabetes, peripheral vascular disease or neuropathy.
- •Subjects with any cutaneous pathology or cuts/abrasions which, in the opinion of the investigator, could compromise safety or affect the outcome of the clinical investigation (for example, interfere with assessments).
- •Subjects with known sensitivity/allergies to any component of the investigational device.
- •Significant current or past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which, in the opinion of the Investigator, would compromise the safety of the subject or affect the outcome of the clinical investigation (as determined from self-reported medical history questionnaire).
- •Use of concomitant medication likely to affect the response to the investigational device or confuse the results of the clinical investigation. Regular pain relief is not permitted and subjects must not take any analgesics in the 24 hours preceding any clinic visit.
- •Female subjects of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent.
- •Pregnancy or lactating mother.
结局指标
主要结局
The proportion of subjects who demonstrate a reduction in the severity of their ingrowing toenail
时间窗: At Day 42 from Day 0
This will be assessed by the Investigator, using the Investigator Ingrowing Toenail Severity Scale.
次要结局
未报告次要终点
研究者
研究点 (2)
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