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
|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|
|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.|
|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|
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
- 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.
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
|Contact: Heidi Hansenemail@example.com|
|United States, Utah|
|University of Utah Hospital||Not yet recruiting|
|Salt Lake City, Utah, United States, 84132|
|Contact: Heidi Hansen 801-585-2373 firstname.lastname@example.org|
|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.email@example.com|
|Principal Investigator:||Colby Hansen, MD||University of Utah|