Feasibility of Self-treatment of Painful Diabetic Neuropathy Using Electrical Vasomotor Nerve Stimulation

Launched by NEURECON BV · Jul 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called Releaf™, designed to help people with painful diabetic neuropathy, a condition that causes discomfort in the feet due to diabetes. The goal of the trial is to see if using this device at home can effectively relieve pain. Previous treatments in a clinic setting were challenging for some patients due to mobility issues, so this study aims to make it easier for individuals to manage their pain from the comfort of their own homes.

To be eligible for the trial, participants should be between the ages of 65 and 74, have painful diabetic neuropathy that hasn't improved with certain medications, and be able to commit to using the Releaf™ device for 10 consecutive days. Participants will need to be in good mental and physical health to complete the treatment and answer some questions about their experience. Throughout the study, they can expect to use the device daily and provide feedback on its effectiveness. It's important to note that individuals with certain medical conditions or those currently involved in other studies will not be able to participate.

Gender

ALL

Eligibility 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.