Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails
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
for mild ingrown toenails
干预措施: Podofix nail brace (Device)
Combiped nail brace
for Severe dystrophic ingrown toenails
干预措施: Combiped nail brace (Device)
Podofix and then Combiped nail brace
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
Huang Yu Chen
Attending physician of Dermatology Department
Taipei Medical University WanFang Hospital
