Hyperhidrosis, Developing a Treatment Approach Aims 1 & 2

• Status: Active, not recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Colby Hansen; University of Utah
• Collaborators: U.S. Army Medical Research and Development Command; US Department of Veterans Affairs
• Treatments: Aluminum chloride; Ethanol

Criteria

Aim 1 and Aim 2

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Open sores or wounds on the residual limb

• Known sensitivity or allergy to iodine

• Known sensitivity to antiperspirant, aluminum chloride hexahydrate