Home treatment for painful diabetic neuropathy using electrical stimulation
Feasibility of Self-treatment of Painful Diabetic Neuropathy Using Electrical Vasomotor Nerve Stimulation
NA · Neurecon BV · NCT06524284
This study is testing a new device called Releaf™ that helps people with painful diabetic neuropathy treat their pain at home using electrical stimulation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Neurecon BV (industry) |
| Locations | 1 site (Vught) |
| Trial ID | NCT06524284 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility, safety, and performance of a new device called Releaf™, designed for home treatment of painful diabetic neuropathy (PDN) using electrical vasomotor nerve stimulation (EVNS). The device aims to enable patients to self-administer treatment at home, addressing challenges faced by those with impaired mobility who struggle to attend outpatient clinics. Participants will use the Releaf™ device for 10 consecutive days while completing questionnaires to assess their experience and outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals with painful diabetic neuropathy who have not found relief from standard medications and are capable of performing home self-treatment.
Not a fit: Patients with other evident causes of painful neuropathy or significant peripheral arterial disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a convenient and effective self-treatment option for patients suffering from painful diabetic neuropathy.
How similar studies have performed: While the use of electrical stimulation for neuropathy has shown promise in other studies, this specific home treatment approach with the Releaf™ device is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Vught
- Neurecon — Vught, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Ben Imholz, PhD, MD — Neurecon BV
- Study coordinator: Hans Kerssemakers, MSc
- Email: hans.kerssemakers@neurecon.com
- Phone: +3173-2340747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Painful Diabetic Neuropathy