Effect of Transcutaneous Electrical Nerve Stimulation in Diabetic Neuropathy
NCT ID: NCT04253860
Last Updated: 2021-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
20 participants
INTERVENTIONAL
2019-02-01
2021-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TENS
Transcutaneous electrical neurostimulation will be applied for 30 minutes three times a week during 90 days
Transcutaneous electrical neurostimulation
Sessions of 30 minutes of TENS will be applied three times a week during 90 days
Sham
A sham comparator will be applied for 30 minutes three times a week during 90 days. The device does not emit electrical impulses
Transcutaneous electrical neurostimulation
Sessions of 30 minutes of TENS will be applied three times a week during 90 days
Interventions
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Transcutaneous electrical neurostimulation
Sessions of 30 minutes of TENS will be applied three times a week during 90 days
Eligibility Criteria
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Inclusion Criteria
* Diagnostic of peripheral diabetic neuropathy less than 5 years
* HbA1C \> 6.5 and \< 9%
* Plasmatic glucose \>140 mg/dL and lees than 350 mg/dL
* Informed consent signed
Exclusion Criteria
* Implanted brain stimulator
* History of alcohol abuse
* Use of NSAID, stereoids
* Subjects with wounds, ulcers in legs
* Subjects with hepatic, renal o neurologic diseases
45 Years
75 Years
ALL
No
Sponsors
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University of Guadalajara
OTHER
Diabetes sin Complicaciones S.A de C.V, Mexico
UNKNOWN
Centro Universitario de Tonalá
OTHER
Responsible Party
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Arieh Roldán Mercado Sesma
Investigator
Principal Investigators
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Arieh R Mercado Sesma, PhD
Role: PRINCIPAL_INVESTIGATOR
Salud Enfermedad como proceso individual, CUTonalá, Universidad de Guadalajara
Locations
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University of Guadalajara
Guadalajara, Jalisco, Mexico
Countries
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Other Identifiers
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TENS-ND-2018
Identifier Type: -
Identifier Source: org_study_id
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