The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride for the treatment of residual limb hyperhidrosis.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
OnabotulinumtoxinA in intradermal Injections on residual lower limb : 100 Units - 1 dose
Topical Aluminium Chloride (cosmetic product) : 1 quantity sufficient on the lower limb
Les Capucins
Angers, France
Hôpital Clermont-Tonnerre
Brest, France
CMPR La Tour de Gassies
Bruges, France
Hopital Percy
Clamart, France
Hyperhidrosis Disease Severity Score (HDSS) evolution
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
Time frame: 24 weeks
Mismatch of prothesis associated with sweat measured by a visual analogue scale
Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if \> 50% increase between initial and final measure
Time frame: 3 years
Problems with walking due to sweat measured by a visual analogue scale
Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if \> 50% increase between initial and final measure
Time frame: 3 years
Sweat quantity measured by a visual analogue scale
Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if \> 50% increase between initial and final measure
Time frame: 3 years
Quality of life measured by a visual analogue scale
Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if \> 50% increase between initial and final measure
Time frame: 3 years
Amount of time spent wearing the prothesis
Amount of time spent wearing the prosthesis (hours per day): efficacy if increase
Time frame: 3 years
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Hopital Laveran
Marseille, France
Pôle Saint Helier
Rennes, France
Centre La Tourmaline
Saint-Herblain, France
Institut Universitaire de Réadaptation Clémenceau
Strasbourg, France
Institut Robert Merle d'Aubigné, IRMA
Valenton, France
Prothesis removed to dry the residual limb
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
Time frame: 3 years
Quality of life(DLQI)
DLQI quality of life questionnaire : efficacy if increase
Time frame: 3 years
Quality of life (physical domain of SF36)
SF36 "limitations due to physical state" specific domain : efficacy if increase
Time frame: 3 years
Quality of life (subjective improvement felt)
Subjective Improvement Felt (SIF) (based on a percentage scale) :efficacy if\>50% increase
Time frame: 3 years