Hyperhidrosis in Amputee

Overview

Status: Recruiting
Keywords: hyperhidrosis , amputation
IRB Number: 00060144
Specialty: Physical Medicine and Rehabilitation
Sub Specialties: Amputee Rehabilitation

Brief Summary

 

The purpose of this project is to develop a treatment approach addressing the problem of hyperhidrosis of the residual limb in patients with amputations.  Excessive sweating of the residual limb is a common complaint in prosthetic users, but there is a lack of published information regarding evaluation and treatment of this problem.  

Successful use of a prosthesis requires a stable interface between the residual limb and the prosthetic socket.  Naturally, maintaining healthy skin is paramount for an amputee patient to successfully use a prosthesis.  However, the closed environment that is necessary to provide this stability also creates an environment which may lead to a multitude of skin problems. 

 

Objective #1:  To validate the feasibility and utility of the minor’s iodine-starch test in amputee patients.

1A.  Feasibility:  Before being relied upon as a potential measure of excessive sweating and as a determinant for injection therapy, it is necessary to determine the best way to administer the iodine-starch test.  Potential pitfalls lie in the introduction of a substance between the patient’s skin and liner such as staining the patient’s prosthetic liner, or altering their fit and making them susceptible to new skin problems.  We plan to administer the iodine-starch test under varying conditions to determine the best way this can be done.

1B.  Utility:  We will administer the iodine-starch test to volunteer patients who do not have complaints of sweating and to patients who report at least moderate sweating on the HDSS.  We will compare results of the iodine starch test between the two groups to determine if a positive starch test is obtained in patients complaining of moderate to severe hyperhidrosis, and if a negative starch test is obtained in those noting no significant hyperhidrosis. 

1C. Determinant of hyperhidrotic areas:  Pending success of objectives 1A and 1B, we will then be able to determine if there are focal areas of hyperhidrosis in amputee patients, or if this is a diffuse process over the entire residual limb.

This information will directly impact the targeted location of any intervention, be it a topical antiperspirant or botulinum toxin injections.

Objective #2: Investigate the effectiveness of a topical antiperspirant on hyperhidrosis of the residual limb.

Efficacy will be determined by comparing the patients’ pre-treatment HDSS score to post-treatment score.  Treatment response is defined as a drop of at least 1 point on the HDSS.  Treatment failure is defined as no change in HDSS, and inadequate response is defined as HDSS of 2 or more post-treatment.

Photographs of minor’s iodine-starch test will be taken before and after treatment with topical antiperspirant and compared to patient’s scores on the HDSS pre- and post-treatment. 

Obejctive #3:  Identify appropriate patients who may be candidates for botulinum toxin therapy, in keeping with published dermatologic recommendations (Solish, Bertucci et al. 2007). 

Published algorithms of hyperhidrosis treatment recommend the use of the iodine-starch test and a trial of antiperspirant therapy before considering botulinum toxin as a treatment alternative.  Accomplishing objectives 1 and 2 of this project will allow us to properly establish a similar treatment protocol for hyperhidrosis in amputee patients, which can then be used in future studies of botulinum toxin therapy.

Principal Investigator: Colby Hansen
Department: Physical Medicine & Rehab
Co Investigator: Colby Hansen

Contact Information

Name:Jonna Winger
Phone: 801-581-5328
Email: Jonna.Winger@hsc.utah.edu

Inclusion Criteria

age >18, at least 6 months post-amputation surgery, have a prosthetic device, no open sores or wounds.  Some phases of the study will require participants to score a 2 or greater on the hyperhidrosis disease severity scale (HDSS)

Exclusion Criteria

open sores or wounds on the residual limb, known sensitivity to iodine or the antiperspirant aluminum chloride hexahydrate.