ClinicalTrials.gov
ClinicalTrials.gov Menu

Hyperhidrosis in Patients With Amputations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03236012
Recruitment Status : Not yet recruiting
First Posted : August 1, 2017
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
Colby Hansen, University of Utah

Brief Summary:
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 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.

Condition or disease Intervention/treatment Phase
Hyperhidrosis Diagnostic Test: Minor Iodine-Starch Test Other: Aluminum Chloride Drug: Botulinum toxin type A Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: Aim 1 and Aim 3 are not masked, but Aim 2 will be masked to the participant and investigator.
Primary Purpose: Treatment
Official Title: Hyperhidrosis of the Residual Limb in Patients With Amputations: Developing a Treatment Approach
Estimated Study Start Date : October 15, 2017
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Iodine Skin Test
The iodine-starch test can be useful in diagnosing hyperhidrosis and grading its severity if it can demonstrate discriminate validity -- to accurately test positive in patients with the condition, and test negative in patients without the condition.
Diagnostic Test: Minor Iodine-Starch Test
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.

Active Comparator: Aluminum Chloride Topical
Test the effectiveness of a prescription strength topical antiperspirant Aluminum Chloride 20 percent on hyperhidrosis of the residual limb.
Other: Aluminum Chloride
Aluminum Chloride 20 percent once daily for twelve weeks.

Experimental: Botulinum Toxin Therapy
Test the effectiveness of Botulinum Toxin therapy in subjects who fail or do not tolerate Aluminum Chloride.
Drug: Botulinum toxin type A
Maximum dose up to 500 units given one time
Other Name: Botox




Primary Outcome Measures :
  1. Change in Hyperhidrosis Disease Severity Scale. [ Time Frame: baseline to 12 weeks ]
    Hyperhidrosis Disease Severity Scale measurement is based of 1-4 points. Score 1 is the lowest severity and score 4 would be the highest severity for sweating.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Male or female, age 18 or older
  • Have a prosthetic device
  • In good general health as evidenced by medical history
  • If subject is currently using aluminum chloride it must be discontinued for at least one week prior to participation in the study

Exclusion Criteria:

  • Open sores or wounds on the residual limb
  • Known sensitivity or allergy to iodine
  • Known sensitivity or allergy to Aluminum Chloride
  • Pregnancy or lactation
  • Known absolute or relative contraindications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236012


Contacts
Contact: Heidi Hansen 801-278-3598 heidi.hansen@hsc.utah.edu

Locations
United States, Utah
University of Utah Hospital Not yet recruiting
Salt Lake City, Utah, United States, 84132
Contact: Heidi Hansen    801-585-2373    heidi.hansen@hsc.utah.edu   
Principal Investigator: Colby Hansen, MD         
George E. Wahlen Department of Veterans Affairs Medical Center Not yet recruiting
Salt Lake City, Utah, United States, 84148
Contact: Bradeigh Godfrey, DO    801-582-1565 ext 1764    Bradeigh.godfrey@va.gov   
Sponsors and Collaborators
Colby Hansen
US Department of Veterans Affairs
Investigators
Principal Investigator: Colby Hansen, MD University of Utah

Responsible Party: Colby Hansen, Principle Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT03236012     History of Changes
Other Study ID Numbers: OP150030
OP150030 ( Other Grant/Funding Number: DOD )
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sweat Gland Diseases
Hyperhidrosis
Skin Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Iodine
Aluminum chloride
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Neuromuscular Agents
Peripheral Nervous System Agents
Astringents
Dermatologic Agents