Diabetic PolyneuropathyHTEMS-RCTNCT04593992
HTEMS Treatment of Diabetic Polyneuropathy
A study testing HTEMS in people with Diabetic Polyneuropathy, run by West German Center of Diabetes and Health at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- HTEMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 20 Oct 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic diabetic neuropathy
- stable oral analgesic regimen
Who cannot join
- history of drug or alcohol abuse
- cardiac pacemaker or defibrillator
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group
Düsseldorf, 40591
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Polyneuropathy
- Being tested
- HTEMS, Placebo
- Keywords
- diabetes, neuropathy, pain, HTEMS
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTEMSDevice
Also called HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany)
high-tone external muscle stimulation
PlaceboDevice
Also called Placebo treatment
Placebo stimulation
| Study group | Role | What they receive |
|---|---|---|
| HTEMS | Experimental | High-tone external muscle stimulation 5 times within a week for 12 weeks Receives: Device: HTEMS |
| Placebo | Placebo comparator | Placebo stimulation 5 times within a week for 12 weeks Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathy symptom score
Neuropathic symptoms measured by the neuropathic symptom score (NSS). Range 1-10 with higher scores indicationg a worse outcome.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start20 Oct 2020
- Primary completion31 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- West German Center of Diabetes and Health
- Sponsor type
- University, hospital or other
- Collaborators
- gbo Medizintechnik AG
- Responsible party
- Principal investigator, Stephan Martin, West German Center of Diabetes and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593992
- Sponsor's protocol ID
- HP study
- Acronym
- HTEMS-RCT
- Status last verified
- Jul 2022
- First submitted
- 14 Oct 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-tone External Muscle Stimulation for Treatment of Diabetic Polyneuropathy
- ClinicalTrials.gov ID
- NCT04593992
- Acronym / sponsor ID
- HTEMS-RCT / HP study
- Conditions
- Diabetic Polyneuropathy
- Keywords
- diabetes, neuropathy, pain, HTEMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- West German Center of Diabetes and HealthUniversity, hospital or other
- Collaborators
- gbo Medizintechnik AG
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HTEMS | Experimental | Device: HTEMSHigh-tone external muscle stimulation 5 times within a week for 12 weeks |
| Placebo | Placebo comparator | Device: PlaceboPlacebo stimulation 5 times within a week for 12 weeks |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- symptomatic diabetic neuropathy
- stable oral analgesic regimen
Key exclusion criteria (3 listed)
- history of drug or alcohol abuse
- cardiac pacemaker or defibrillator
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTEMSAlso: HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany)high-tone external muscle stimulation | Device | HTEMS |
| PlaceboAlso: Placebo treatmentPlacebo stimulation | Device | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HTEMS in people with Diabetic Polyneuropathy, run by West German Center of Diabetes and Health at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathy symptom score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.