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Clinical Trials/EUCTR2013-004293-10-ES
EUCTR2013-004293-10-ES
Active, not recruiting
Phase 1

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

Hospital Universitari de Tarragona Joan XXIII0 sitesApril 1, 2014
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Hospital Universitari de Tarragona Joan XXIII
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 1, 2014
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Hospital Universitari de Tarragona Joan XXIII

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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