Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03236012 · ClinicalTrials.gov registry record · Phase 1
Hyperhidrosis in Patients With Amputations-Botox
A Phase 1 study of Hyperhidrosis, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 2
- Study locations
NCT03236012 is a Phase 1 study of Hyperhidrosis that has completed, run by University of Utah. The registered enrollment target is 25 participants, below the 96-participant average among 8 other Hyperhidrosis trials with a reported enrollment target (74% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03236012, a Phase 1 study of Hyperhidrosis, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Botulinum Toxin Type A (Botox)
Study Locations (2)
Utah
- University of Utah Hospital - Salt Lake City
- George E. Wahlen Department of Veterans Affairs Medical Center - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-01-08 |
| Est. Completion | 2022-02-14 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03236012
The ClinicalTrials.gov registry entry for NCT03236012 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 96-participant average among 8 other Hyperhidrosis trials with a reported enrollment target (74% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hyperhidrosis appearing as the primary indexed condition, and to 1 intervention - of which Botulinum Toxin Type A (Botox) is the first listed.
NCT03236012 reports 2 study locations spanning 1 distinct geographic area - top geographies include Utah.
Frequently Asked Questions
What is clinical trial NCT03236012 about?
NCT03236012 is a clinical study titled "Hyperhidrosis in Patients With Amputations-Botox". 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 ne...
What is the current status of trial NCT03236012?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2019-01-08. Estimated completion is 2022-02-14.
What conditions does trial NCT03236012 study?
This clinical trial studies the following conditions: Hyperhidrosis.
What interventions are being tested in trial NCT03236012?
The interventions under investigation include: Botulinum Toxin Type A (Botox) (DRUG).
Who is sponsoring clinical trial NCT03236012?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03236012 being conducted?
This trial has 2 study locations across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hyperhidrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Botulinum Toxin Therapy in Hidradenitis Suppurativa
RECRUITING
-
Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis
COMPLETED · Phase 2
-
Safety and Efficacy of an Anticholinergic Agent for Treatment of Primary Axillary Hyperhidrosis
COMPLETED · Phase 2
-
Feasibility Study: Ulthera® System for the Treatment of Axillary Hyperhidrosis
COMPLETED · NA
-
A Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
COMPLETED · Phase 2
-
A Study to Evaluate Clinical Effect, Pharmacokinetics , Safety, and Tolerability of Umeclidinium in Palmar Hyperhidrosis Subjects
COMPLETED · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.