NL-OMON41598招募中3 期
aser therapy for onychomycosis in patients with diabetes at risk for diabetic foot complications A randomized, double blind controlled trial. - LASER-1
Isala Klinieken0 个研究点目标入组 64 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
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
- 年龄范围
- 18 至 99（—）
入选标准
- •known diabetes (type 1 or 2)
- •over 18 years old
- •clinically suspicion with microbiologic confirmation of onychomycosis
- •at risk for diabetic foot ulcers defined by a Simm*s score 1 or 2
- •the nail has to be involved for at least 25% .
排除标准
- •patients without microbiologic confirmation of fungal nail infection
- •patients with diabetic foot ulcers or foot ulcer in the medical history
- •patients who used systemic or topical antifungal agents during the preceding 3 months
- •patients with insufficient knowledge of the Dutch language to understand the requirements of the study
- •patients who use immunosuppressive medication will also be excluded.
- •patients suffering from psoriasis with nail involvement, lichen planus, or other abnormalities that could result in clinically abnormal toenails will be excluded.
- •patients with an ankle brachial index <0.9 and/or toepressure <50 mmHg
- •patients with ischaemic rest pain.
- •Patients with severe renal failure (eGFR<30 ml/min) or dialysis.
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