Back to resultsEffect of Transcutaneous Electrical Nerve Stimulation in Diabetic Neuropathy
Primary Purpose
Diabetic Neuropathy Peripheral
Status
Terminated
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Transcutaneous electrical neurostimulation
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy Peripheral focused on measuring Diabetic neuropathy peripheral, diabetic complications, TENS, Neuropathic treatments
Eligibility Criteria
Inclusion Criteria:
- Diagnostic of type 2 diabetes > 10 years
- 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:
- Use of implanted pacemaker or heart defibrillator
- Implanted brain stimulator
- History of alcohol abuse
- Use of NSAID, stereoids
- Subjects with wounds, ulcers in legs
- Subjects with hepatic, renal o neurologic diseases
Sites / Locations
- University of Guadalajara
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
TENS
Sham
Arm Description
Transcutaneous electrical neurostimulation will be applied for 30 minutes three times a week during 90 days
A sham comparator will be applied for 30 minutes three times a week during 90 days. The device does not emit electrical impulses
Outcomes
Primary Outcome Measures
Pain perception
Evaluation of neuropathic pain evaluated with VAS
Secondary Outcome Measures
Tumoral Necrosis Factor Alpha
Serum levels of TNF-alpha
Interleukin-6
Serum levels of IL-6
C Reactive Protein ultra-sensible
Serum levels of CRP-us
Full Information
NCT ID
NCT04253860
First Posted
January 30, 2020
Last Updated
July 29, 2021
Sponsor
Centro Universitario de Tonalá
Collaborators
University of Guadalajara, Diabetes sin Complicaciones S.A de C.V, Mexico
1. Study Identification
Unique Protocol Identification Number
NCT04253860
Brief Title
Effect of Transcutaneous Electrical Nerve Stimulation in Diabetic Neuropathy
Official Title
Effect of Transcutaneous Electrical Nerve Stimulation on Pain percepción and Serum Inflammatory Markers in Patients With Peripheral Diabetic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to pandemic od COVID-19, was difficult recruit patients
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
July 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitario de Tonalá
Collaborators
University of Guadalajara, Diabetes sin Complicaciones S.A de C.V, Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Double-blind, randomized, placebo-controlled, clinical trial. Patients with diabetic neuropathy will be randomly assigned to treatment with either TENS or TENS sham three times a week during 90 days. Clinical determinations are: pain, levesls of TNF-alpha, IL-6 and RPC-us
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy Peripheral
Keywords
Diabetic neuropathy peripheral, diabetic complications, TENS, Neuropathic treatments
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, clinical trial
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TENS
Arm Type
Experimental
Arm Description
Transcutaneous electrical neurostimulation will be applied for 30 minutes three times a week during 90 days
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
A sham comparator will be applied for 30 minutes three times a week during 90 days. The device does not emit electrical impulses
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical neurostimulation
Intervention Description
Sessions of 30 minutes of TENS will be applied three times a week during 90 days
Primary Outcome Measure Information:
Title
Pain perception
Description
Evaluation of neuropathic pain evaluated with VAS
Time Frame
Change from Baseline Pain perception at 90 days
Secondary Outcome Measure Information:
Title
Tumoral Necrosis Factor Alpha
Description
Serum levels of TNF-alpha
Time Frame
Change from Baseline serum levels of TNF-alpha at 90 days
Title
Interleukin-6
Description
Serum levels of IL-6
Time Frame
Change from Baseline serum levels of IL-6 at 90 days
Title
C Reactive Protein ultra-sensible
Description
Serum levels of CRP-us
Time Frame
Change from Baseline serum levels of CRP-us at 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnostic of type 2 diabetes > 10 years
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:
Use of implanted pacemaker or heart defibrillator
Implanted brain stimulator
History of alcohol abuse
Use of NSAID, stereoids
Subjects with wounds, ulcers in legs
Subjects with hepatic, renal o neurologic diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arieh R Mercado Sesma, PhD
Organizational Affiliation
Salud Enfermedad como proceso individual, CUTonalá, Universidad de Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
45425
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Transcutaneous Electrical Nerve Stimulation in Diabetic Neuropathy
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