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临床试验/NCT03008629
NCT03008629Unknown不适用

Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails

Taipei Medical University WanFang Hospital0 个研究点目标入组 40 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
主要终点
Improvement (change) by Physician global assessment (0-6)

研究概览

简要总结

Background: Ingrown toenails are one of the most frequent nail disorders and can be treated with conservative or surgical approaches. Although discovered a long time ago, the available data are still very limited on the potential effectiveness of nail braces for ingrown toenail treatment.

Objective: This study aimed to evaluate the efficacy of nail brace (combiped and podofix) for treatment of ingrown toenails.

详细描述

Method: Participants with ingrown toenail and >= 12 years old with total 40 ingrown toenails were included. Investigators divide patients to 3 group: (1) combiped group: Participants with non-infected or mild infected ingrown nail, combiped nail brace was applied instantly.20 patients(2) combine combiped and podofix group: Participants with severe paronychia with pyogenic granuloma, oral analgesics and antibiotics were prescribed first and nail brace was applied 1 week later. Depends on disease condition, investigators applied 1-2 combiped nail brace. If the pyogenic granuloma is not resolved after 1 week, investigators applied podofix first for 2-4 weeks and then combiped nail brace. After the nail brace applied, participants must come back between 2-4 weeks depends on disease condition.10 patients (3) podofix group: participants who are afraid of combiped implantation, or with mild recurrence will be applied with podofix.

Participants come back every month for evaluation and photography. Physician global assessment (0-6),Patient global assessment (VAS 0-10), Treatment satisfaction (VAS 0-10), and questionnaire were evaluated 1 month, 3 months and 6 months after the device applied. Participants need to be followed for recurrence at 3rd month and 6th month after removed the nail brace.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •more or equal to 12 years old patient with ingrown toenail

排除标准

  • •< 12 years old
  • •under other nail bracing use
  • •received partial nail resection within recent 2 months
  • •psoriatic nail
  • •target therapy related paronychia
  • •received combiped or podofix previously and removed within recent 6 months

研究组 & 干预措施

Podofix nail brace

Experimental

for mild ingrown toenails

干预措施: Podofix nail brace (Device)

Combiped nail brace

Experimental

for Severe dystrophic ingrown toenails

干预措施: Combiped nail brace (Device)

Podofix and then Combiped nail brace

Experimental

for Ingrown toenails with pyogenic granuloma

干预措施: Podofix and then Combiped nail brace (Device)

结局指标

主要结局

Improvement (change) by Physician global assessment (0-6)

时间窗: 1 month, 3 months and 6 months after the device applied

次要结局

  • Pain score (VAS0-10)(1 month, 3 months and 6 months after the device applied)
  • Improvement (change) by Patient global assessment (VAS 0-10)(1 month, 3 months and 6 months after the device applied)
  • Treatment satisfaction (VAS 0-10)(1 month, 3 months and 6 months after the device applied)
  • Quality of life by Questionnaire(1 month, 3 months and 6 months after the device applied)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Huang Yu Chen

Attending physician of Dermatology Department

Taipei Medical University WanFang Hospital

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