Hyperhidrosis, Residual Limbs
Conditions
Keywords
Lower limb amputation, Hyperhidrosis, Prosthetic users, Aluminum chloride, Sweating
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.
Interventions
OTHERTopical 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.
Sponsors
Sophies Minde Ortopedi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The project is carried out as a pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Norway
Outcome results
None listed