Hyperhidrosis of the Residual Limb in Patients With Amputations: Developing a Treatment Approach, Aims 1 and Aim 2
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Hyperhidrosis Disease Severity Scale (HDSS)
研究概览
简要总结
The objective is to establish an evidence base for a hyperhidrosis treatment algorithm in amputees. This project will address a problem that has troubled Service members, Veterans, and civilians with amputations for decades, impacting satisfaction with prosthetic use, residual limb skin health, and negatively affecting quality of life. Prior research in this area has been limited and insufficient. The Investigators are confident that improving the evaluation and treatment of residual limb hyperhidrosis will reduce the secondary health consequences of amputation and will lead to improved quality of life. This will be accomplish by completing the following specific aims.
Aim 1: Test the validity of the Minor iodine-starch test in amputees. Hypothesis: The iodine-starch test is a valid diagnostic tool of hyperhidrosis and can be useful for the identification of focal areas of sweating on a residual limb Aim 2: Test the effectiveness of a prescription strength topical antiperspirant (Aluminum Chloride 20%) on hyperhidrosis of the residual limb.
Hypothesis: Aluminum Chloride will be more effective at controlling sweating than placebo
详细描述
One objective of the Prosthetic Outcomes Research Award (PORA) is to improve the understanding of secondary health effects on Service members and Veterans who have undergone limb amputation and to advance the adoption and implementation of evidence-based interventions. The investigators will address the important secondary health problem of excessive residual limb sweating (hyperhidrosis) in amputees.
Successful use of a prosthesis requires a stable interface between the residual limb and the prosthetic socket. Maintaining healthy skin, therefore, is paramount. However, the closed environment necessary to provide this stable interface also creates an environment that may lead to a multitude of skin problems. Amputees regularly deal with skin problems such as sweating, eczematous itching and redness, infections, and mechanical problems such as blisters and open wounds. Hyperhidrosis is the single most reported problem. Hyperhidrosis is reported in up to 70% of amputee and is associated with reduced quality of life, reduced prosthetic fit and function, decreased satisfaction with their prosthesis and skin irritation. The investigators own published findings reveal that 66% of prosthetic users (both veteran and civilian) experienced residual limb sweating that interfered with activities of daily living. Sweating was rated as most bothersome in warm weather or with vigorous activity, and the efficacy of treatment strategies was generally reported to be poor.
Despite the frequency and impact of hyperhidrosis in amputees, there is a lack of evidence based guidelines for evaluating and treating this problem. A number of knowledge gaps exist, including no clear standard for assessing the burden of sweating in amputees, and no evidence base from which to inform treatment decisions for either simple or more elaborate interventions.
There is no universally accepted standard for assessing the burden and precise location of sweating in amputee patients. Among the several subjective scales of hyperhidrosis severity in the dermatology literature, the most commonly used and rigorously validated one is the Hyperhidrosis Disease Severity Scale (HDSS). The HDSS provides a qualitative measure for the severity of the patient's condition based on the extent to which hyperhidrosis affects daily activities. The HDSS is simple to administer and scored as follows:
Hyperhidrosis Disease Severity Scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
For Aim 1 there will be no masking. Aim 2, recruitment methods will be by convenience sampling. Subjects in Aim 1 reporting an HDSS of 2 or greater and additional subjects as needed from the U of U or VA clinics with HDSS of 2 or greater will be invited to participate in this crossover study. Subjects will be randomized equally to two sequence arms by a random number generator. The first arm will receive in sequential order every 3 weeks: Aluminum Chloride, a placebo of ethyl alcohol base, Aluminum Chloride, and placebo. The second arm will receive in sequential order every 3 weeks: placebo, Aluminum Chloride, placebo, and Aluminum Chloride. Each condition will last for 3 weeks, which will allow enough time for the Aluminum Chloride and placebo to demonstrate their respective effects. The first week of each period will also serve as a sufficient washout for the previous period. The total trial length, then, will be 12 weeks.
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
- •Provision of signed and dated informed consent form (ICF)
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, age 18 or older
- •Have a prosthetic device
- •In good general health as evidenced by medical history
- •If subject is currently using aluminum chloride participant must be discontinued for at least one week prior to participation in the study.
排除标准
- •Open sores or wounds on the residual limb
- •Known sensitivity or allergy to iodine
- •Known sensitivity to antiperspirant, aluminum chloride hexahydrate
研究组 & 干预措施
Placebo Comparator AIM 1
Aim 1: Demonstration of a strong association of the Sweating Intensity Visual Scale (SIVS) score with the HDSS would provide validation for use of the SIVS in interpreting the iodine-starch test and would establish the value of the iodine-starch test in clinical practice guidelines for diagnosing hyperhidrosis in amputees, just as it is in dermatology practice.
干预措施: Aluminum Chloride 20% (deodorant) (Drug)
Placebo Comparator AIM 1
Aim 1: Demonstration of a strong association of the Sweating Intensity Visual Scale (SIVS) score with the HDSS would provide validation for use of the SIVS in interpreting the iodine-starch test and would establish the value of the iodine-starch test in clinical practice guidelines for diagnosing hyperhidrosis in amputees, just as it is in dermatology practice.
干预措施: Alcohol (Drug)
Aluminum Chloride vs Placebo in Amputees
Aim 2: The investigators will have completed the first clinical trial of Aluminum Chloride for residual limb hyperhidrosis. The investigators will then have a solid foundation of data that demonstrates the rates of adverse effects such as skin irritation, and rates and magnitudes of improvement in subjective and objective measures of sweating.
干预措施: Aluminum Chloride 20% (deodorant) (Drug)
Aluminum Chloride vs Placebo in Amputees
Aim 2: The investigators will have completed the first clinical trial of Aluminum Chloride for residual limb hyperhidrosis. The investigators will then have a solid foundation of data that demonstrates the rates of adverse effects such as skin irritation, and rates and magnitudes of improvement in subjective and objective measures of sweating.
干预措施: Alcohol (Drug)
结局指标
主要结局
Hyperhidrosis Disease Severity Scale (HDSS)
时间窗: 1 day
The outcome measure of Aim 1 will be measuring the Hyperhidrosis Disease Severity Scale (HDSS). The HDSS is scored on a number scale of 1-4. Score range from 1 (lowest) demonstrating sweating (hyperhidrosis) is least noticeable and does not interfere with daily activities (least impactful) to 4 (highest) sweating is intolerable and interferes significantly with daily activities. This measurement will be completed in a single site visit.
次要结局
- Hyperhidrosis Disease Severity Scale (HDSS)(12 weeks)
研究者
Colby Hansen
Principle Investigator
University of Utah
