HTEMS Treatment of Diabetic Polyneuropathy | NCT04593992

Studies
HTEMS Treatment of Diabetic Polyneuropathy

NCT04593992

Sponsor

West German Center of Diabetes and Health

Status

Completed

Last Update Posted

Jul 20, 2022Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Diabetic Polyneuropathy

Interventions

HTEMS
Placebo

Countries

Germany

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 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2020Actual

Primary Completion Date

Oct 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Oct 14, 2020

First Submission Date that Met QC Criteria

Oct 14, 2020

First Posted Date

Oct 20, 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 19, 2022

Last Update Posted Date

Jul 20, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stephan Martin, Principal investigator, West German Center of Diabetes and HealthPrincipal Investigator

Lead Sponsor

West German Center of Diabetes and HealthOTHER

Collaborators

Name	Class
gbo Medizintechnik AG	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

So far, there are no sufficient pharmacologic therapies for the treatment of diabetic neuropathy. Therefore, we evaluated application of high-tone external muscle stimulation (HTEMS) compared to placebo treatment in patients with diabetic neuropathy.

Detailed Description

Patients (n=80) with symptomatic diabetic neuropathy will be included into this randomized controlled trial. Each intervention will be administered for a period of at least 30 min on at leat 5 days in a week. Health impairments will be assessed using the neuropathy symptom score (NSS) before, during and after intervention.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HTEMS	Experimental	High-tone external muscle stimulation 5 times within a week for 12 weeks	Device: HTEMS
Placebo	Placebo Comparator	Placebo stimulation 5 times within a week for 12 weeks	Device: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HTEMS	Device	high-tone external muscle stimulation	HTEMS	HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neuropathy symptom score	Neuropathic symptoms measured by the neuropathic symptom score (NSS). Range 1-10 with higher scores indicationg a worse outcome.	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

symptomatic diabetic neuropathy
stable oral analgesic regimen

Exclusion Criteria:

history of drug or alcohol abuse
cardiac pacemaker or defibrillator
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group		Düsseldorf		40591	Germany

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
D003929	Diabetic Neuropathies
D003920	Diabetes Mellitus
D010146	Pain

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D048909	Diabetes Complications

Browse Leaves

Not provided

Browse Branches

Not provided