The objective is to establish and evidence base for 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. We plan to conduct an open label study of Botox, up to 400
units, to treat limb hyperhidrosis in patients with amputations. The actual dose of Botox
used will be based on individual results with the Iodine-Starch test to identify areas on the
residual limb that are producing excessive sweat. Botulinum Toxin A (BTX-A): Botulinum toxin
therapy is well-established for use in excessive sweating of several body areas (axillary,
palmar, plantar, and facial) in individuals with hyperhidrosis and inadequate response to
topical treatments. Extensive research has been conducted on the efficacy and safety of BTX-A
for hyperhidrosis of other areas, and it has been shown to improve both objective and
subjective measures of sweating, and lead to improved quality of life measures.
This will be accomplished by completing the following:
Test the validity of the Minor iodine-starch test in amputees.
1. 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.
2. Treat the residual limb Hyperhidrosis with Botox, up to and limited to 400 units.
Hypothesis: Treatment of residual limb Hyperhidrosis with Botox will result in improved
patient reports of excessive sweating as measured by the HDSS and as measured by subjects'
response to iodine-starch testing. We 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.
Phase:
Phase 1
Details
Lead Sponsor:
Colby Hansen University of Utah
Collaborators:
U.S. Army Medical Research and Development Command U.S. Army Medical Research and Materiel Command US Department of Veterans Affairs
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A onabotulinumtoxinA