New home gadget may ease diabetic foot pain
NCT ID NCT06524284
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested if people with painful diabetic neuropathy can safely use a new electrical stimulation device at home. 40 adults who had not gotten enough relief from standard pain medicines used the device for 10 days. The goal was to see if the device is easy to use and has side effects, not to prove it works.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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40 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Mar 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Painful Diabetic Neuropathy (DN4 positive) and insufficiently treated with any combination of 2 of the following drugs: Duloxetine (Cymbalta), venlafaxine (Efexor), ami- or nortriptyline, gabapentine, pregabaline (Lyrica) or the use of carbamazepine or capsaïcine (Qutenza). * Both feet are present * Able and willing to complete the treatments in 10 days in a row and completion of questionnaires. * Being in a mental and physical state to perform home self-treatment with Releaf™ for 10 consecutive days, if necessary with adequate assistance of caregiver. * Being in a mental and physical state to understand and complete the informed consent form as well as the research questionnaires. Exclusion Criteria: * In case of other evident causes for painful neuropathy, * Currently participating in another interventional investigational study * Significant peripheral arterial disease, * Active foot ulceration or other skin conditions that prevent the application of electrodes on the skin * Current alcohol or other substance abuse (use of alcohol over the recommended limits of less than 21 units of alcohol per week in men and 14 units in women, Trimbos Intitute), * Epilepsy, * Pregnancy, * Presence of a medical device based on electrical stimulation, cardiac pacemaker and/or implantable cardioverter defibrillator or any other active implant * Allergy to electrode contact area or to the adhesive substance of the electrode.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Neurecon
Vught, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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