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NCT Number: NCT05501444

Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users

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.

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Key information

Conditions

Hyperhidrosis Residual Limbs Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sophies Minde Ortopdi AS

Oslo, 0667, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical antiperspirant

Other

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 outcomes

  1. Hyperhidrosis Disease Severity Scale (HDSS)

    Time frame: 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.

  2. Sweating Intensity Visual Scale (SIVS)

    Time frame: 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 outcomes

  1. Numerical Ranking Scale (NRS 100)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sophies Minde Ortopedi

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 15, 2022
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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