Effect of Transcutaneous Electrical Nerve Stimulation in... | NCT04253860

Studies
Effect of Transcutaneous Electrical Nerve Stimulation in Diabetic Neuropathy

NCT04253860

Sponsor

Centro Universitario de Tonalá

Status

Terminated

Last Update Posted

Aug 4, 2021Actual

Enrollment

20Actual

Phase

Phase 3

Conditions

Diabetic Neuropathy Peripheral

Interventions

Transcutaneous electrical neurostimulation

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to pandemic od COVID-19, was difficult recruit patients

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Sep 1, 2020Actual

Completion Date

Jul 30, 2021Actual

First Submitted Date

Jan 30, 2020

First Submission Date that Met QC Criteria

Jan 31, 2020

First Posted Date

Feb 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2021

Last Update Posted Date

Aug 4, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arieh Roldán Mercado Sesma, Investigator, Centro Universitario de TonaláPrincipal Investigator

Lead Sponsor

Centro Universitario de TonaláOTHER

Collaborators

Name	Class
University of Guadalajara	OTHER
Diabetes sin Complicaciones S.A de C.V, Mexico	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Transcutaneous electrical neurostimulation	Device	Sessions of 30 minutes of TENS will be applied three times a week during 90 days	Sham TENS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain perception	Evaluation of neuropathic pain evaluated with VAS	Change from Baseline Pain perception at 90 days

Secondary Outcomes

Measure	Description	Time Frame
Tumoral Necrosis Factor Alpha	Serum levels of TNF-alpha	Change from Baseline serum levels of TNF-alpha at 90 days
Interleukin-6	Serum levels of IL-6

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arieh R Mercado Sesma, PhD	Salud Enfermedad como proceso individual, CUTonalá, Universidad de Guadalajara	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Guadalajara		Guadalajara	Jalisco	45425	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D048909	Diabetes Complications

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided