Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05501444
Other study ID # FoU_2022_Hyperhidrosis
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04924036 - Qbrexza Cloths for Hyperhidrosis of Amputation Sites Phase 2
Recruiting NCT05102396 - Topical Oxybutynin for Treatment of Hyperidrosis: Local or Systemic Effect? Phase 2
Recruiting NCT04178161 - Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis N/A
Completed NCT02565732 - Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis Phase 2
Completed NCT02552199 - A Non-Interventional Study To Assess Sweating
Recruiting NCT01930604 - Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis Phase 2
Completed NCT01811004 - Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis N/A
Completed NCT01671800 - Study to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis-associated Sweating Phase 1
Completed NCT01956591 - Long Term Results of the Use of Oxybutynin for the Treatment of Hyperhidrosis N/A
Completed NCT01934153 - Characterization of Exposure From Topical Administration of [14C] Umeclidinium to Axilla or Palm of Healthy Male Subjects Phase 1
Completed NCT06113978 - Thoracoscopic Sympathetic Chain Interruption for Palmar Hyperhidrosis in Patients Below 18 N/A
Completed NCT04906655 - An Open Label Study for Palmar Hyperhydrosis Phase 2
Completed NCT05247333 - Implementation of a Minor Ailment Service in Community Pharmacy Practice N/A
Completed NCT02563899 - Pharmacokinetic, Safety, Tolerability, and Clinical Effect of Topical Umeclidinium in Primary Axillary Hyperhidrosis Phase 2
Withdrawn NCT05546710 - miraDry Post Market Tumescent Anesthesia Study N/A
Completed NCT02016885 - A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis Phase 2
Completed NCT00168480 - A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis Phase 4
Completed NCT03416348 - Hyperhidrosis, Developing a Treatment Approach Aims 1 & 2 Phase 1
Completed NCT02973659 - The Use of Topical Oxybutynin 10% for Treating Primary Focal Hyperhidrosis-axillary, Palmar and Plantar. N/A
Recruiting NCT05805696 - Treatment and Mapping of Impostor Phenomenon N/A