NCT04593992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 20, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

October 14, 2020

Last Update Submit

July 19, 2022

Conditions

Diabetic Polyneuropathy

Keywords

diabetesneuropathypainHTEMS

Outcome Measures

Primary Outcomes (1)

  • Neuropathy symptom score

    Neuropathic symptoms measured by the neuropathic symptom score (NSS). Range 1-10 with higher scores indicationg a worse outcome.

    12 weeks

Study Arms (2)

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

HTEMSDEVICE

high-tone external muscle stimulation

Also known as: HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany)
HTEMS
PlaceboDEVICE

Placebo stimulation

Also known as: Placebo treatment
Placebo

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptomatic diabetic neuropathy
  • stable oral analgesic regimen

You may not qualify if:

  • history of drug or alcohol abuse
  • cardiac pacemaker or defibrillator
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group

Düsseldorf, 40591, Germany

Location

MeSH Terms

Conditions

Diabetic NeuropathiesDiabetes MellitusPain

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 14, 2020

First Posted

October 20, 2020

Study Start

October 20, 2020

Primary Completion

October 31, 2021

Study Completion

December 31, 2021

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)