Painful Diabetic Neuropathy
Conditions
Brief summary
Electrical stimulation with EVNS (Electrical Vasomotor Neuro Stimulation), a methodology used by a specific group of neurostimulators known under various names, has proven its benefit in Painful Diabetic Neuropathy (PDN). However, due to the impaired mobility from Diabetic Neuropathy, a part of subjects did not finish the 10 days treatment in the outpatient clinic. Another part of the target group decided not to participate at all for the same reason. The current study investigates the feasibility, safety and performance of a newly developed EVNS device, called Releaf™, optimised for HOME treatment,
Interventions
DEVICEReleaf
10 days/35 minutes per day EVNS (non-invasive electrostimulation) treatment on lower legs and feet by the subject or its caregiver after instruction by the podiatrist.
Sponsors
Neurecon BV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Side-effects | Day 1-10 | The number and severity of reported side-effects of HOME-EVNS, gathered via telephonic consulting on treatment day 1,3 and 8 and via user-initiated incoming calls to the PI |
| Successful treatment cycles | Day 11 | The successful treatment cycles applied at home, defined as cycles with at least 8/10 successful (full 35 minutes) treatment sessions, derived from the adherence determined by recording device usage and intensity setting which is downloaded from device after its retrieval |
| Reported usability | Day 10 | Usability by the User Questionnaire |
| Use of helpdesk | Day 1-10 | The number of help requests to service desk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic pain | Before start, after 1 month, after 3 months | Neuropathic Pain Symptom Inventory (NPSI) filled in by subject |
| Quality of life score | Before start, after 1 month, after 3 months | EuroQol 5 Dimension 5 Level (EQ-5D-5L) QoL filled in by subject |
Countries
Netherlands
Outcome results
None listed