Hyperhidrosis in Patients With Amputations-Botox
Public ClinicalTrials.gov record NCT03236012. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Hyperhidrosis of the Residual Limb in Patients With Amputations: Developing a Treatment Approach
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03236012
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 25 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 7, 2019
- Primary completion
- Jan 14, 2022
- Completion
- Feb 13, 2022
- Last update posted
- Oct 16, 2022
2019 – 2022
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
| George E. Wahlen Department of Veterans Affairs Medical Center | Salt Lake City | Utah | 84148 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03236012, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 16, 2022 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03236012 live on ClinicalTrials.gov.