Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users

Hyperhidrosis Clinical Trial

Official title:

Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05501444
• Other study ID #: FoU_2022_Hyperhidrosis
• Status: Completed
• Phase: N/A
• Start date: August 9, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: April 2023
• Source: Sophies Minde Ortopedi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Over 18 years,

2. used a prosthetic for at least 1 year,

3. HDSS score of = 2,

4. use the prosthetic daily and be able to walk for a minimum of 10 minutes.

Exclusion Criteria:

1. Open wounds on the stump,

2. Known sensitivity or allergy to iodine and/or starch,

3. Known sensitivity to antiperspirant.

Related Conditions & MeSH terms

• Hyperhidrosis
• Residual Limbs

Intervention

Other:
• Topical antiperspirant
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.

Locations

Country	Name	City	State
Norway	Sophies Minde Ortopdi AS	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Sophies Minde Ortopedi

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Four weeks
Primary	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)	Four weeks
Secondary	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	Four weeks