- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04593992
HTEMS Treatment of Diabetic Polyneuropathy (HTEMS-RCT)
July 19, 2022 updated by: Stephan Martin, West German Center of Diabetes and Health
High-tone External Muscle Stimulation for Treatment of Diabetic Polyneuropathy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Düsseldorf, Germany, 40591
- West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- symptomatic diabetic neuropathy
- stable oral analgesic regimen
Exclusion Criteria:
- history of drug or alcohol abuse
- cardiac pacemaker or defibrillator
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HTEMS
High-tone external muscle stimulation 5 times within a week for 12 weeks
|
high-tone external muscle stimulation
Other Names:
|
Placebo Comparator: Placebo
Placebo stimulation 5 times within a week for 12 weeks
|
Placebo stimulation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropathy symptom score
Time Frame: 12 weeks
|
Neuropathic symptoms measured by the neuropathic symptom score (NSS).
Range 1-10 with higher scores indicationg a worse outcome.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2020
Primary Completion (Actual)
October 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
October 14, 2020
First Submitted That Met QC Criteria
October 14, 2020
First Posted (Actual)
October 20, 2020
Study Record Updates
Last Update Posted (Actual)
July 20, 2022
Last Update Submitted That Met QC Criteria
July 19, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Polyneuropathy
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Eva PharmaMARC-CRORecruiting
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Imperial College LondonActegy Ltd.Not yet recruitingDiabetic Neuropathies | Diabetic Peripheral Neuropathy | Diabetic Polyneuropathy | Diabetic ComplicationUnited Kingdom
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Ilko Ilac San. ve Tic. A.S.CompletedPeripheral (Sensorimotor) Diabetic Polyneuropathy
-
Mundipharma Research GmbH & Co KGCompletedModerate to Severe Pain Due to Diabetic PolyneuropathyGermany
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Maastricht University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedDiabetic Patients With PolyneuropathyNetherlands
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NycomedCompletedSymptomatic Diabetic Peripheral PolyneuropathyDenmark
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Timothy J. Best Medicine Professional CorporationThe Physicians' Services Incorporated FoundationCompleted
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MEDA Pharma GmbH & Co. KGCompletedDiabetic PolyneuropathyIsrael, Russian Federation
-
Eisai Inc.CompletedMild to Moderate Diabetic Sensorimotor PolyneuropathyUnited States
-
Eastern Virginia Medical SchoolNational Institutes of Health (NIH)CompletedDiabetic; Neuropathic, Polyneuropathy (Manifestation)United States
Clinical Trials on HTEMS
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West German Center of Diabetes and Healthgbo Medizintechnik AGCompletedChronic Radicular Back Pain | Lumboischialgia | Cervico BrachialgiaGermany