Hyperhidrosis, Residual Limbs
Conditions
Brief summary
The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride for the treatment of residual limb hyperhidrosis.
Detailed description
After randomization patients will receive either OnabotulinumtoxinA once or topical aluminium chloride for 6 months. All patients will be evaluated during 3 study visits (week 4, week 12, week 24) and 1 phone call (week 18).
Interventions
DRUGOnabotulinumtoxinA
OnabotulinumtoxinA in intradermal Injections on residual lower limb : 100 Units - 1 dose
OTHERTopical Aluminium Chloride (cosmetic product)
Topical Aluminium Chloride (cosmetic product) : 1 quantity sufficient on the lower limb
Sponsors
Direction Centrale du Service de Santé des Armées
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Lower limb amputees suffering from residual limb hyperhidrosis with important cutaneous, functional, social and professional consequences, whatever the amputation cause * HDSS ≥ 2 (Hyperhidrosis Disease Severity Score) * Men and women * 18 to 75 years old * Written informed consent * No
Exclusion criteria
* Social assurance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hyperhidrosis Disease Severity Score (HDSS) evolution | 24 weeks | HDSS score : min 1 - max. 4 * Efficacy : HDSS evolution from 2 (initial measure) to 1 (final measure), from 3 (initial measure) to 1 or 2 (final measure), from 4 (initial measure) to 1 or 2 (final measure) * Failure : from 2 (initial measure) to 2 (final measure), from 3 or 4 (initial measure) to 2 (final measure) ; or increase of HDSS between initial and final measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Problems with walking due to sweat measured by a visual analogue scale | 3 years | Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if \> 50% increase between initial and final measure |
| Sweat quantity measured by a visual analogue scale | 3 years | Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if \> 50% increase between initial and final measure |
| Quality of life measured by a visual analogue scale | 3 years | Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if \> 50% increase between initial and final measure |
| Amount of time spent wearing the prothesis | 3 years | Amount of time spent wearing the prosthesis (hours per day): efficacy if increase |
| Mismatch of prothesis associated with sweat measured by a visual analogue scale | 3 years | Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if \> 50% increase between initial and final measure |
| Quality of life(DLQI) | 3 years | DLQI quality of life questionnaire : efficacy if increase |
| Quality of life (physical domain of SF36) | 3 years | SF36 limitations due to physical state specific domain : efficacy if increase |
| Quality of life (subjective improvement felt) | 3 years | Subjective Improvement Felt (SIF) (based on a percentage scale) :efficacy if\>50% increase |
| Prothesis removed to dry the residual limb | 3 years | Number of times the prosthesis had to be removed to dry the residual limb and sleeve per day: efficacy if no need to remove it or only once a day |
Countries
France
Outcome results
None listed