Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Hyperhidrosis Disease Severity Scale (HDSS)
研究概览
简要总结
The aim of the present pilot study is to evaluate the effect of antiperspirant to treat residual limb hyperhidrosis with the emphasis on the utility of the iodine-starch test to identify the location of the sweating.
详细描述
Many persons with lower limb amputation report that they have major problems with sweating (hyperhidrosis) on the stump in connection with prosthetic use. Despite the frequency and the negative effect of sweating for prosthetic users, there is a lack of evidence on how the sweating should be examined and treated. In the dermatological literature, the guidelines recommend the use of topical antiperspirants such as aluminum chloride as first-line treatment. No studies have previously been published evaluating the effect of antiperspirant on prosthetic users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Over 18 years,
- •used a prosthetic for at least 1 year,
- •HDSS score of ≥ 2,
- •use the prosthetic daily and be able to walk for a minimum of 10 minutes.
排除标准
- •Open wounds on the stump,
- •Known sensitivity or allergy to iodine and/or starch,
- •Known sensitivity to antiperspirant.
结局指标
主要结局
Hyperhidrosis Disease Severity Scale (HDSS)
时间窗: Four weeks
The HDSS is a short single-item scale that is scored from 1-4 and provides a qualitative measure of the severity of sweating based on the extent to which sweating affects daily activities.
Sweating Intensity Visual Scale (SIVS)
时间窗: Four weeks
In connection with the Minor test, it is also recommended to use the Sweating Intensity Visual Scale (SIVS) in order to provide a more objective and standardized interpretation of the results of the Minor test. SIVS is graded on a scale from 0-V (Grade 0= minimal or no sweating, Grade I = initial, discrete sweating, Grade II = mild sweating, Grade III = moderate sweating, Grade IV = intense sweating, and Grade V= oversweating)
次要结局
- Numerical Ranking Scale (NRS 100)(Four weeks)