EUCTR2020-005653-24-ES
Active, Not Recruiting
Phase 1
Effectiveness of botulinum toxin infiltration in spasticity of the 1st toe in patients with neurological pathology
Clínica Integral del pie-Ana Sans0 sites120 target enrollmentJune 14, 2021
ConditionsThe application of Botox is described in the technical sheet for spasticity and has already been applied to the foot. This is how we speak of a phase IV clinical trial, with a low level of intervention.Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsBotox 50
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- The application of Botox is described in the technical sheet for spasticity and has already been applied to the foot. This is how we speak of a phase IV clinical trial, with a low level of intervention.
- Sponsor
- Clínica Integral del pie-Ana Sans
- Enrollment
- 120
- Status
- Active, Not Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Neurological patients aged 18 to 80 years
- •Patients with stroke, parkinson's or multiple sclerosis, who present spasticity of the 1st toe.
- •Spasticity of the 1st toe, pain and gait instability.
- •Hyperextension of the 1st finger, causing inability to put on shoes, in neurological patients.
- •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 60
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 60
Exclusion Criteria
- •Skin ulcers
- •In pregnancy and lactation the use is contraindicated.
- •Minor patients and those patients who do not have the authorization of a family member or guardian.
- •Individuals with known hypersensitivity to botulinum toxin type A or to any of the excipients of the formulation.
- •In case of infection at the proposed injection site (s).
- •Eaton Lambert Syndrome patients.
- •Patients with severe dysphagia or respiratory compromise.
- •Patients with myasthenia gravis.
Outcomes
Primary Outcomes
Not specified
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