Residual Limb Hyperhidrosis is the investigated medical condition.
Conditions
Interventions
Trade Name: BOTOX, 100 units
Pharmaceutical Form: Powder for solution for injection
Pharmaceutical form of the placebo: Cutaneous liquid
Route of admini
Sponsors
DIRECTION CENTRALE DU SERVICE DE SANTE DES ARMEES
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Lower limb amputees suffering from residual limb hyperhydrosis 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: • Botulinum toxin injection necessity for another disease • Evolutive Central neurologic disease or myasthenia. • Egg or albumine allergy • Botulinum toxin or other excipients hypersensibility • Legally protected Adults and people unable to give an informed consent. (article L-1121-8 from Public Health Code), people without freedom and people hospitalized without consent (article L-1121-6 from Public Health Code) • Pregnant women or giving breast women (article L-1121-5 from Public Health) • Patient refusing participating • Previous hyperhidrosis treatment with aluminium chloride in the last 4 weeks • Previous hyperhidrosis treatment with boutlinum toxin in the last 2 years • Other ongoing hyperhidrosis treatment • Large residual limb eczematiform lesions: corticoïde treatment (for example : Locapred® 1 application per day during 1 week then decrease). • Aminoglycoside ongoing treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to demonstrate Onabotulinumtoxin A superiority to aluminium chloride for the treatment of residual limb hyperhidrosis; Secondary Objective: To compare quality of life improvement To compare functional improvement To observe treatment impact on pain To compare treatment tolerance ; Primary end point(s): decrease of HDSS: - efficacy : from 2 to 1, from 3 to 1 or 2, from 4 to 1 or 2 - failure : from 2 to 2, from 3 or 4 to 2; or increase of HDSS INITIAL HDSS FINAL HDSS CONCLUSION 2 2 failure 2 1 efficacy 3 ou 4 3 ou 4 failure 3 ou 4 1 ou 2 efficacy ; Timepoint(s) of evaluation of this end point: Day 0 Week 4 Week 12 Week 18 Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Amount of time spent wearing the prosthesis (hours per day): efficacy if increase • 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 • Visual Analogue Scale (VAS) for mismatch of prosthesis associated with sweat (using 100 mm scale): efficacy if>50% increase • VAS for problems with walking due to sweat (using 100 mm scale): efficacy if>50% increase • VAS for overall discomfort associated with sweat (using 100 mm scale) : efficacy if>50% increase • VAS sweat quantity (using 100 mm scale) : efficacy if>50% increase • VAS quality of life (using 100 mm scale) : efficacy if increase • DLQI quality of life questionnaire : efficacy if increase • SF36 "limitations due to physical state" specific domain : efficacy if increase • Subjective Improvement Felt (SIF) (based on a percentage scale) : efficacy if>50% increase • VAS for sweat quantity (using 100 mm scale) : efficacy if>50% increase • Pain in the residual limb, phantom limb and neuroma : observation • Description of skin damage : efficacy if disappear ; Timepoint(s) of evaluation of this end point: Day 0 Week 4 Week 12 Week 18 Week 24 | — |
Countries
France
Contacts
Public ContactMedecin en chef Le Bevic
DIRECTION CENTRALE DU SERVICE DE SANTE DES ARMEES
Outcome results
None listed