An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cysts
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- cyst resolution at 6 weeks
研究概览
简要总结
Digital myxoid cysts arise from degeneration in the connective tissue of the digit joint, usually the last joint of the finger or toe, often due to underlying joint arthritis. They may connect with the joint. Pressure from the cyst can result in deformity of the digit's nail and trauma to the cyst results in leakage of the fluid, representing a potential source of entry for infection. Cysts can be tender and interfere with the digit's function. A variety of treatments are available, from simple extrusion which is rarely successful, to more destructive cryotherapy, infra-red coagulation and formal excision under local anaesthetic. These latter three approaches can result in considerable scarring. Sclerosant injection of polidocanol in one small non-randomised trial has been reported to be a well tolerated efficacious treatment with minimal scarring and long-term resolution. Following a pilot study, the investigators aim to trial this treatment to assess efficacy in a larger population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •All patients referred to dermatology in NHS Lothian or NHS Fife who have a visible Digital Myxoid Cyst affective the dital phalynx of the toes or fingers.
- •The patient must have the ability to give informed consent
排除标准
- •History of sensitivity to polidocanol or other sclerosants
- •Age less than 18
- •Inability to give informed consent
- •Inability to report side effects experienced
- •Cyst not clearly visible
- •Cyst not fluid-filled
研究组 & 干预措施
polidocanol
干预措施: polidocanol (Drug)
cryotherapy
干预措施: cryotherapy (Procedure)
infra-red coagulation
干预措施: infra-red coagulation (Procedure)
结局指标
主要结局
cyst resolution at 6 weeks
时间窗: 6 weeks
Is there a difference in the percentage of participants with cyst resolution at 6 weeks post treatment in those treated with polidocanol compared to those treated with the current conventional treatments of cryotherapy and infra-red coagulation?
次要结局
- cyst resolution at 12 and 52 weeks(1 year)
- pain scores on a visual analogue scale(1 year)
- procedure satisfaction on a visual analogue scale(1 year)
- difference in scarring(1 year)
