Hyperhidrosis in Patients With Amputations-Botox

• Status: Active, not recruiting
• Trial end date: 2023-12-14
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

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

Criteria

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