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

Phase 1

• Conditions: Stump hyperhidrosis in lower limb amputees; MedDRA version: 16.1Level: PTClassification code 10020642Term: HyperhidrosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2013-004293-10-ES
• Lead Sponsor: Hospital Universitari de Tarragona Joan XXIII

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-01
• Last Update Posted: 21 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified