ISRCTN17865863已完成未知
A randomised pilot clinical investigation of a novel plasma device (PF4) with concurrent controls in toenail onychomycosis
Solent NHS Trust (UK)0 个研究点目标入组 80 人开始时间: 2017年2月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Participants who can provide informed consent
- •2. Male or female participants
- •3. Aged 18-80
- •4. Mycologically confirmed distal subungual onychomycosis in both hallux toenails with 25 – 75% involvement of the nail area
排除标准
- •1. Participants < 18 years old
- •2. Participants > 80 years old
- •3. Participants currently being treated for onychomycosis or who have been treated within the past four months using topical drug therapies
- •4. Participants who have taken oral antifungal agents or had laser treatments in the last 12 months
- •5. Participants who have been involved in other drug or medical device clinical trials in the past 3 months which may affect the safety or efficacy of this study
- •6. Participants with ulcerations around the toe nails
- •7. Participants with total dystrophic onychomycosis involving the lunula/nail matrix
- •8. Participants with peripheral vascular disease, immune-suppression, loss of sensation in either foot, or with any other medical state which warrants definitive antifungal therapy
- •9. Participants with <25% or >75% onychomycosis involvement of the nail area
- •10. No use of nail varnish on the toe nails for at least four weeks before the first treatment and for at least four months after the last treatment
- •11. Participants with proximal subungual onychomycosis
- •12. Participants with superficial white onychomycosis
- •13. Participants with psoriasis, lichen planus or other medical condition which has the ability to induce nail changes
- •14. Participants who cannot communicate competently in English
- •15. Women of childbearing potential who are, or might be, pregnant at the time of the study enrolment or who plan to become pregnant within three months of the study treatment
- •16. Participants with a pacemaker, implantable cardiac device, deep brain stimulator, gastric stimulator or any other electrically powered implantable device
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