Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis; Residual Limbs
• Intervention / Treatment: Other: Topical antiperspirant

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0667
    • Sophies Minde Ortopdi AS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Effect of antiperspirant; Aluminium chloride 15 percent	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sophies Minde Ortopedi
• Investigators: Principal Investigator: Jette Schack, PhD, Sophies Minde Ortopedi

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Hyperhidrosis; Lower limb amputation; Sweating; Prosthetic users; Aluminum chloride
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: FoU_2022_Hyperhidrosis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No