Efficacy of treatment by iontophoresis of botulinum toxin type A free from complexing proteins for the excessive sweating of the stump

Efficacy of treatment by iontophoresis of botulinum toxin type A free from complexing proteins for stump hyperhidrosis - HYPERHIDROSIS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004293-10-ES

Enrollment

Unknown

Registered

2014-04-01

Start date

2014-06-03

Completion date

Unknown

Last updated

2016-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stump hyperhidrosis in lower limb amputees MedDRA version: 16.1 Level: PT Classification code 10020642 Term: Hyperhidrosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: Xeomin Product Name: Botulinum neurotoxin type A free from complexing proteins Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Clostridium Botulinum Neurotoxin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Lower limb amputation at any level. - Evolution of time since the amputation: 6 months or more. - Prosthesis wearers. - Activity level: K2-K4. - Excessive sweating of the stump that produces alteration in the use / fit of the prosthesis. - Approval and signing of informed consent. - Age >18. 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: - Having another type of treatment for excessive sweating of the stump. - Existence of contraindications to the use of botulinum toxin: hypersensitivity to the molecule, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, peripheral neuromuscular disorders. - Having a pacemaker. - Cutaneous impairment in the stump: infection or loss of skin integrity. - Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: Check the effectiveness of botulinum toxin type A free of complexing proteins used by iontophoresis to decrease sweating of lower limb stump.;Secondary Objective: - Assess comfort / tolerability/adverse effects of the technique - Determine the duration of effect - Assess if there are significant changes in patients? quality of life - Assess if significant changes occur in six minutes walking test - Assess if there is any impact on the level of pain on the stump and the phantom limb;Primary end point(s): Questionnaire: - How much sweat do you have during the day? (VAS 0-10) - How much does sweat interfere in the placement of the prosthesis? (VAS 0-10) - How long can you walk without losing adhesion of the prosthesis? (timed) - How many times a day do you have to remove the prosthesis to dry the stump and the socket? - How much pain do you have in the amputation stump? (VAS 0-10) - How much phantom limb pain do you have? (VAS 0-10);Timepoint(s) of evaluation of this end point: One week before and 15 days after placebo intervention,15 days, 1.5 months, 2.5 months and 3.5 months after real intervention.	—

Measure

Time frame

Main Objective: Check the effectiveness of botulinum toxin type A free of complexing proteins used by iontophoresis to decrease sweating of lower limb stump.;Secondary Objective: - Assess comfort / tolerability/adverse effects of the technique - Determine the duration of effect - Assess if there are significant changes in patients? quality of life - Assess if significant changes occur in six minutes walking test - Assess if there is any impact on the level of pain on the stump and the phantom limb;Primary end point(s): Questionnaire: - How much sweat do you have during the day? (VAS 0-10) - How much does sweat interfere in the placement of the prosthesis? (VAS 0-10) - How long can you walk without losing adhesion of the prosthesis? (timed) - How many times a day do you have to remove the prosthesis to dry the stump and the socket? - How much pain do you have in the amputation stump? (VAS 0-10) - How much phantom limb pain do you have? (VAS 0-10);Timepoint(s) of evaluation of this end point: One week before and 15 days after placebo intervention,15 days, 1.5 months, 2.5 months and 3.5 months after real intervention.

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Secondary

Measure	Time frame
Secondary end point(s): - Pain / Discomfort during the procedure (VAS 0-10) - Scale of quality of life: SF-36. - 6 minute walking test - Complications / adverse effects.;Timepoint(s) of evaluation of this end point: One week before and 15 days after placebo intervention,15 days, 1.5 months, 2.5 months and 3.5 months after real intervention.	—

Countries

Spain

Contacts

Public ContactIria Bascuas Rodríguez

Hospital Universitari de Tarragona Joan XXIII

irivenir@gmail.com34977295801

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026