Effect of Transcutaneous Electrical Nerve Stimulation in Diabetic Neuropathy

NCT04253860 | Terminated Phase 3 DMC

• 1 other identifier: TENS-ND-2018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Neuropathy Peripheral

Keywords

Diabetic neuropathy peripheral; diabetic complications; TENS; Neuropathic treatments

Outcome Measures

Primary Outcomes (1)

• Pain perception

  Evaluation of neuropathic pain evaluated with VAS

  Change from Baseline Pain perception at 90 days

Secondary Outcomes (3)

• Tumoral Necrosis Factor Alpha

  Change from Baseline serum levels of TNF-alpha at 90 days

• Interleukin-6

  Change from Baseline serum levels of IL-6 at 90 days

• C Reactive Protein ultra-sensible

  Change from Baseline serum levels of CRP-us at 90 days

Study Arms (2)

TENS

EXPERIMENTAL

Transcutaneous electrical neurostimulation will be applied for 30 minutes three times a week during 90 days

Device: Transcutaneous electrical neurostimulation

Sham

SHAM COMPARATOR

A sham comparator will be applied for 30 minutes three times a week during 90 days. The device does not emit electrical impulses

Device: Transcutaneous electrical neurostimulation

Interventions

Transcutaneous electrical neurostimulation DEVICE

Sessions of 30 minutes of TENS will be applied three times a week during 90 days

Sham; TENS

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Universitario de Tonalá: lead
• University of Guadalajara: collaborator
• Diabetes sin Complicaciones S.A de C.V, Mexico: collaborator

Study Sites (1)

University of Guadalajara

Guadalajara, Jalisco, 45425, Mexico

Location

MeSH Terms

Conditions

Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Arieh R Mercado Sesma, PhD

  Salud Enfermedad como proceso individual, CUTonalá, Universidad de Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: Randomized, double-blind, clinical trial

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: February 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: July 30, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)