Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users
Primary Purpose
Hyperhidrosis, Residual Limbs
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Topical antiperspirant
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhidrosis focused on measuring Lower limb amputation, Hyperhidrosis, Prosthetic users, Aluminum chloride, Sweating
Eligibility Criteria
Inclusion Criteria:
- Over 18 years,
- used a prosthetic for at least 1 year,
- HDSS score of ≥ 2,
- use the prosthetic daily and be able to walk for a minimum of 10 minutes.
Exclusion Criteria:
- Open wounds on the stump,
- Known sensitivity or allergy to iodine and/or starch,
- Known sensitivity to antiperspirant.
Sites / Locations
- Sophies Minde Ortopdi AS
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Effect of antiperspirant
Arm Description
Aluminium chloride 15 percent
Outcomes
Primary Outcome Measures
Hyperhidrosis Disease Severity Scale (HDSS)
The HDSS is a short single-item scale that is scored from 1-4 and provides a qualitative measure of the severity of sweating based on the extent to which sweating affects daily activities.
Sweating Intensity Visual Scale (SIVS)
In connection with the Minor test, it is also recommended to use the Sweating Intensity Visual Scale (SIVS) in order to provide a more objective and standardized interpretation of the results of the Minor test. SIVS is graded on a scale from 0-V (Grade 0= minimal or no sweating, Grade I = initial, discrete sweating, Grade II = mild sweating, Grade III = moderate sweating, Grade IV = intense sweating, and Grade V= oversweating)
Secondary Outcome Measures
Numerical Ranking Scale (NRS 100)
Numerical Ranking Scale (NRS 100) (with 0 as low and 100 as high) is used to investigate the following question:
How much sweating do you experience on the stump?
How much does sweating affect your function?
How much does sweating reduce your quality of life?
How much does sweating affect walking related to instability?
How much does sweating affect your activity level?
How much does sweating affect your skin quality on the stump
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05501444
Brief Title
Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users
Official Title
Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 9, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
March 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sophies Minde Ortopedi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the present pilot study is to evaluate the effect of antiperspirant to treat residual limb hyperhidrosis with the emphasis on the utility of the iodine-starch test to identify the location of the sweating.
Detailed Description
Many persons with lower limb amputation report that they have major problems with sweating (hyperhidrosis) on the stump in connection with prosthetic use. Despite the frequency and the negative effect of sweating for prosthetic users, there is a lack of evidence on how the sweating should be examined and treated. In the dermatological literature, the guidelines recommend the use of topical antiperspirants such as aluminum chloride as first-line treatment. No studies have previously been published evaluating the effect of antiperspirant on prosthetic users.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis, Residual Limbs
Keywords
Lower limb amputation, Hyperhidrosis, Prosthetic users, Aluminum chloride, Sweating
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The project is carried out as a pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Effect of antiperspirant
Arm Type
Experimental
Arm Description
Aluminium chloride 15 percent
Intervention Type
Other
Intervention Name(s)
Topical antiperspirant
Intervention Description
The participants will be instructed to use topical antiperspirant (aluminum chloride, 15 percent every evening for four weeks. The PI will contact the participants every week. If the participant experiences that antiperspirant have an effect, the use of antiperspirant will be reduced from daily use to 3 times a week.
Primary Outcome Measure Information:
Title
Hyperhidrosis Disease Severity Scale (HDSS)
Description
The HDSS is a short single-item scale that is scored from 1-4 and provides a qualitative measure of the severity of sweating based on the extent to which sweating affects daily activities.
Time Frame
Four weeks
Title
Sweating Intensity Visual Scale (SIVS)
Description
In connection with the Minor test, it is also recommended to use the Sweating Intensity Visual Scale (SIVS) in order to provide a more objective and standardized interpretation of the results of the Minor test. SIVS is graded on a scale from 0-V (Grade 0= minimal or no sweating, Grade I = initial, discrete sweating, Grade II = mild sweating, Grade III = moderate sweating, Grade IV = intense sweating, and Grade V= oversweating)
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Numerical Ranking Scale (NRS 100)
Description
Numerical Ranking Scale (NRS 100) (with 0 as low and 100 as high) is used to investigate the following question:
How much sweating do you experience on the stump?
How much does sweating affect your function?
How much does sweating reduce your quality of life?
How much does sweating affect walking related to instability?
How much does sweating affect your activity level?
How much does sweating affect your skin quality on the stump
Time Frame
Four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over 18 years,
used a prosthetic for at least 1 year,
HDSS score of ≥ 2,
use the prosthetic daily and be able to walk for a minimum of 10 minutes.
Exclusion Criteria:
Open wounds on the stump,
Known sensitivity or allergy to iodine and/or starch,
Known sensitivity to antiperspirant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jette Schack, PhD
Organizational Affiliation
Sophies Minde Ortopedi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sophies Minde Ortopdi AS
City
Oslo
ZIP/Postal Code
0667
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users
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