Status:
COMPLETED
Hyperhidrosis in Patients With Amputations-Botox
Lead Sponsor:
University of Utah
Collaborating Sponsors:
US Department of Veterans Affairs
U.S. Army Medical Research and Development Command
Conditions:
Hyperhidrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 am...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03236012
Start Date
January 8 2019
End Date
February 14 2022
Last Update
October 17 2022
Active Locations (2)
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1
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
2
George E. Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, Utah, United States, 84148