Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users

Not Applicable

Completed

• Conditions: Residual Limbs; Hyperhidrosis
• Interventions: Other: Topical antiperspirant

• Registration Number: NCT05501444
• Lead Sponsor: Sophies Minde Ortopedi

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.

Study Timeline

• Study Start: 2022-08-09
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-11
• Study First Posted: 2022-08-15
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Effect of antiperspirant	Topical antiperspirant	Aluminium chloride 15 percent

Primary Outcome Measures

Name	Time	Method
Hyperhidrosis Disease Severity Scale (HDSS)	Four weeks	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)	Four weeks	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

Name	Time	Method
Numerical Ranking Scale (NRS 100)	Four weeks	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

Trial Locations

Locations (1)

Sophies Minde Ortopdi AS; 🇳🇴 Oslo, Norway