Hyperhidrosis in Patients With Amputations-Botox

Age Range:18 - Any
Start Date:January 8, 2019
End Date:May 14, 2020
Contact:Heidi Hansen

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Hyperhidrosis of the Residual Limb in Patients With Amputations: Developing a Treatment Approach

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.

Subjects who meet inclusion criteria will be given Botox injections. The maximum dose that
will be used will vary from patient to patient up to 400 units.

We will test the effectiveness of botulinum toxin therapy in those who fail Aluminum
Chloride. Failure will be defined as a non-response (no change in HDSS), inadequate response
(post-treatment HDSS of 2 or more), or intolerance to Aluminum Chloride. This would be a
natural progression of interventions consistent with guidelines for other forms of
hyperhidrosis. Specifically, we will study botulinum toxin type A BTX-A, brand name Botox.
While there are other BTX-A products on the market, Botox is the only FDA approved toxin for
the treatment of axillary hyperhidrosis.

There are a few considerations to make when dosing Botox for hyperhidrosis. These include the
total dose, the dose per injection site, and the distribution of injection sites. Typical
doses for axillary hyperhidrosis are 50- 100 units per axilla18. However, for clinical trials
used to support the FDA-approved labeling in focal spasticity, doses up to 400 units were
used. There are reports of off label dosing exceeding this amount, including the case series
reported by Charrow for residual limb hyperhidrosis, which used doses ranging from 300 - 500
units of Botox. There was no mention of adverse events in this series. It has been suggested
that doses greater than 600 units pose a greater risk of serious adverse events including
systemic weakness. Regarding dose per injection site, hyperhidrosis guidelines suggest 1 unit
per site for the axilla, and 1.5 - 2 units per site for the palm or sole18. The largest case
series in amputees used doses of 2-3 units per site. Regarding the distribution of injection
sites, guidelines recommend injections every 1 - 2 cm in a grid-like fashion.

We plan to conduct an open label study of Botox, up to 400 units, in amputees who have failed
treatment with a topical antiperspirant.

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

- At least 6 months post-amputation surgery

- Have a prosthetic device

- In good general health as evidenced by medical history

- HDSS score of 2 or greater AND failed prior treatment with topical Aluminum Chloride.

- At least 6 months from last injection with any botulinum toxin

Exclusion Criteria

- Open sores or wounds on the residual limb

- Known sensitivity or allergy to iodine

- Pregnancy or lactation

- Any prior Hypersensitivity reaction to Botox including anaphylaxis, serum sickness,
urticaria, soft tissue edema, and dyspnea

- Infection at the injection site

- Known neuromuscular junction disorder

- Inflammation at the injection site

- A known compromised respiratory status which may include the use of oxygen, recent
hospitalization for respiratory illness, including but not limited to recent
antibiotic treatment for pneumonia, bronchitis or other respiratory tract infections
will not be allowed to participate

- Overactive bladder with a history of recurrent urinary tract infection (UTI) or two or
more UTI's
We found this trial at
Salt Lake City, Utah 84148
Phone: 801-585-6998
Salt Lake City, UT
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Salt Lake City, Utah 84132
Principal Investigator: Colby Hansen, MD
Phone: 801-585-2373
Salt Lake City, UT
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