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NCT04593992 Clinical Trial

HTEMS Treatment of Diabetic Polyneuropathy

Diabetic Polyneuropathy Clinical Trial

— HTEMS-RCT  

Official title:
High-tone External Muscle Stimulation for Treatment of Diabetic Polyneuropathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04593992
Other study ID # HP study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 20, 2020
Est. completion date December 31, 2021

Study information
Verified date July 2022
Source West German Center of Diabetes and Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date December 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - symptomatic diabetic neuropathy - stable oral analgesic regimen Exclusion Criteria: - history of drug or alcohol abuse - cardiac pacemaker or defibrillator - pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• HTEMS
high-tone external muscle stimulation
• Placebo
Placebo stimulation

Locations
Country Name City State
Germany West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group Düsseldorf

Sponsors (2)
Lead Sponsor Collaborator
West German Center of Diabetes and Health gbo Medizintechnik AG

Country where clinical trial is conducted

Germany, 

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