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Painful Diabetic NeuropathyHOME-EVNSNCT06524284

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

A study testing Releaf in people with Painful Diabetic Neuropathy, run by Neurecon BV at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Painful Diabetic Neuropathy
What is being tested?
Releaf
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteNetherlands
Study dates
22 Jul 2024to 30 Mar 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Neurecon

    Vught

Other trials in Netherlands

About this study

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,

Being tested
Releaf
Medical subject headings
Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReleafDevice

    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.

Study groups in NCT06524284
Study groupRoleWhat they receive
EVNS treatmentExperimentalEVNS, see intervention
Receives: Device: Releaf

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Side-effects

    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

    Measured: Day 1-10

  2. Successful treatment cycles

    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

    Measured: Day 11

  3. Reported usability

    Usability by the User Questionnaire

    Measured: Day 10

  4. Use of helpdesk

    The number of help requests to service desk.

    Measured: Day 1-10

Secondary outcomes (2)

  1. Neuropathic pain

    Neuropathic Pain Symptom Inventory (NPSI) filled in by subject

    Measured: Before start, after 1 month, after 3 months

  2. Quality of life score

    EuroQol 5 Dimension 5 Level (EQ-5D-5L) QoL filled in by subject

    Measured: Before start, after 1 month, after 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2024
  2. Study start22 Jul 2024
  3. Primary completion4 Mar 2025
  4. Study completion30 Mar 2025

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06524284
Sponsor's protocol ID
HOME-EVNS-01
Acronym
HOME-EVNS
Status last verified
Apr 2025
First submitted
23 Jul 2024
Last updated
9 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alleman CJ, Westerhout KY, Hensen M, Chambers C, Stoker M, Long S, van Nooten FE. Humanistic and economic burden of painful diabetic peripheral neuropathy in Europe: A review of the literature. Diabetes Res Clin Pract. 2015 Aug;109(2):215-25. doi: 10.1016/j.diabres.2015.04.031. Epub 2015 May 6.

    PubMed 26008721

  • Azmi S, Petropoulos IN, Ferdousi M, Ponirakis G, Alam U, Malik RA. An update on the diagnosis and treatment of diabetic somatic and autonomic neuropathy. F1000Res. 2019 Feb 15;8:F1000 Faculty Rev-186. doi: 10.12688/f1000research.17118.1. eCollection 2019.

    PubMed 30828432

  • Bevilacqua M, Dominguez LJ, Barrella M, Barbagallo M. Induction of vascular endothelial growth factor release by transcutaneous frequency modulated neural stimulation in diabetic polyneuropathy. J Endocrinol Invest. 2007 Dec;30(11):944-7. doi: 10.1007/BF03349242.

    PubMed 18250616

  • Bocchi L, Evangelisti A, Barrella M, Scatizzi L, Bevilacqua M. Recovery of 0.1Hz microvascular skin blood flow in dysautonomic diabetic (type 2) neuropathy by using Frequency Rhythmic Electrical Modulation System (FREMS). Med Eng Phys. 2010 May;32(4):407-13. doi: 10.1016/j.medengphy.2010.02.004. Epub 2010 Mar 6.

    PubMed 20207576

  • Bosi E, Conti M, Vermigli C, Cazzetta G, Peretti E, Cordoni MC, Galimberti G, Scionti L. Effectiveness of frequency-modulated electromagnetic neural stimulation in the treatment of painful diabetic neuropathy. Diabetologia. 2005 May;48(5):817-23. doi: 10.1007/s00125-005-1734-2. Epub 2005 Apr 15.

    PubMed 15834546

  • Bosi E, Bax G, Scionti L, Spallone V, Tesfaye S, Valensi P, Ziegler D; FREMS European Trial Study Group. Frequency-modulated electromagnetic neural stimulation (FREMS) as a treatment for symptomatic diabetic neuropathy: results from a double-blind, randomised, multicentre, long-term, placebo-controlled clinical trial. Diabetologia. 2013 Mar;56(3):467-75. doi: 10.1007/s00125-012-2795-7. Epub 2012 Dec 13.

    PubMed 23238789

  • Crasto W, Altaf QA, Selvaraj DR, Jack B, Patel V, Nawaz S, Murthy N, Sukumar N, Saravanan P, Tahrani AA. Frequency Rhythmic Electrical Modulation System (FREMS) to alleviate painful diabetic peripheral neuropathy: A pilot, randomised controlled trial (The FREMSTOP study). Diabet Med. 2022 Mar;39(3):e14710. doi: 10.1111/dme.14710. Epub 2021 Nov 3.

    PubMed 34605077

  • D'Souza RS, Barman R, Joseph A, Abd-Elsayed A. Evidence-Based Treatment of Painful Diabetic Neuropathy: a Systematic Review. Curr Pain Headache Rep. 2022 Aug;26(8):583-594. doi: 10.1007/s11916-022-01061-7. Epub 2022 Jun 18.

    PubMed 35716275

  • Dworkin RH, Turk DC, Revicki DA, Harding G, Coyne KS, Peirce-Sandner S, Bhagwat D, Everton D, Burke LB, Cowan P, Farrar JT, Hertz S, Max MB, Rappaport BA, Melzack R. Development and initial validation of an expanded and revised version of the Short-form McGill Pain Questionnaire (SF-MPQ-2). Pain. 2009 Jul;144(1-2):35-42. doi: 10.1016/j.pain.2009.02.007. Epub 2009 Apr 7.

    PubMed 19356853

  • Emerson GG, Segal SS. Electrical activation of endothelium evokes vasodilation and hyperpolarization along hamster feed arteries. Am J Physiol Heart Circ Physiol. 2001 Jan;280(1):H160-7. doi: 10.1152/ajpheart.2001.280.1.H160.

    PubMed 11123230

  • Gibson W, Wand BM, Meads C, Catley MJ, O'Connell NE. Transcutaneous electrical nerve stimulation (TENS) for chronic pain - an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2019 Apr 3;4(4):CD011890. doi: 10.1002/14651858.CD011890.pub3.

    PubMed 30941745

  • Gorczyca-Siudak D, Dziemidok P. The 8-Week Efficacy of Frequency Rhythmic Electrical Modulated System (FREMS) as an Add-on Therapy in the Treatment of Symptomatic Diabetic Peripheral Polyneuropathy. Int J Environ Res Public Health. 2022 Dec 22;20(1):111. doi: 10.3390/ijerph20010111.

    PubMed 36612433

  • Gunter C, Delbeke J, Ortiz-Catalan M. Correction to: Safety of long-term electrical peripheral nerve stimulation: review of the state of the art. J Neuroeng Rehabil. 2020 Jun 15;17(1):77. doi: 10.1186/s12984-020-00695-1.

    PubMed 32539841

  • Imholz B, Heijster J, Tahrani A, Kooy A. Treatment of Painful Diabetic Neuropathy Using Frequency Rhythmic Electro Magnetic Neural Stimulation (FREMS); Effectiveness in Daily Practice. Diabetes Metab Syndr Obes. 2023 May 11;16:1383-1391. doi: 10.2147/DMSO.S401727. eCollection 2023.

    PubMed 37197061

  • Johnson MI, Paley CA, Jones G, Mulvey MR, Wittkopf PG. Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study). BMJ Open. 2022 Feb 10;12(2):e051073. doi: 10.1136/bmjopen-2021-051073.

    PubMed 35144946

Questions about this trial

What is this clinical trial studying?

A study testing Releaf in people with Painful Diabetic Neuropathy, run by Neurecon BV at 1 site in Netherlands.

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 5 inclusion and 9 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 9 Dec 2025. 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 Netherlands. 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. 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?

Side-effects (time frame: Day 1-10). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06524284, which also lists 23 linked publications.

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 9 Dec 2025.

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