Diabetic Peripheral NeuropathyNCT07818993
Effects of Functional Magnetic Stimulation in Sensory and Motor Function in Diabethic Neuropathy
A study testing Functional Magnetic Stimulation in people with Diabetic Peripheral Neuropathy, run by University of Primorska at 1 site in Slovenia.
Trial summary
This study evaluated whether a 2-week course of functional magnetic stimulation applied to the plantar region of the foot could improve sensory function, foot muscle force, postural control, and functional mobility in adults with type 2 diabetes mellitus and diabetic peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Functional Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 24 Sep 2025to 25 Apr 2026
- 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
- Adults with type 2 diabetes mellitus and diabetic peripheral polyneuropathy documented in their medical records
- Ability to walk independently with or without an assistive device
- Ability to understand and follow study procedures
Who cannot join
- Conditions that could independently affect balance or foot function
- Contraindications to magnetic stimulation
- Active foot ulceration
- Recent lower-limb injury or surgery
- Severe neurological or musculoskeletal disease unrelated to diabetic peripheral neuropathy
- Cognitive impairment preventing valid participation
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Zdravstveni dom Koper
Koper, Urban Municipality of Koper, 6000
About this study
Official title: Effects of Functional Magnetic Stimulation on Sensory, Motor, and Functional Outcomes in Individuals With Diabetic Peripheral Neuropathy: A Randomized Controlled Trial
This study evaluated whether a 2-week course of functional magnetic stimulation applied to the plantar region of the foot could improve sensory function, foot muscle force, postural control, and functional mobility in adults with type 2 diabetes mellitus and diabetic peripheral neuropathy. Participants were assigned to active functional magnetic stimulation or sham stimulation. The study hypothesis was that repeated functional magnetic stimulation would improve sensory and motor function and lead to better functional performance compared with sham stimulation.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Functional Magnetic Stimulation, Sham Functional Magnetic Stimulation
- Keywords
- functional magnetic stimulation, peripheral magnetic stimulation, plantar sensation, foot strength, diabetic peripheral neuropathy, vibration perception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Magnetic StimulationDevice
Pulsed magnetic stimulation was delivered to the plantar region of the foot using the FMS Stym device (Iskra Medical, Slovenia). Participants completed 12 sessions over 2 weeks, each lasting 20 minute
Sham Functional Magnetic StimulationDevice
Sham treatment reproduced the positioning, appearance, schedule, and duration of active functional magnetic stimulation while a metal plate substantially attenuated the magnetic field reaching the foo
| Study group | Role | What they receive |
|---|---|---|
| Functional Magnetic Stimulation | Experimental | Participants received functional magnetic stimulation applied to the plantar region of the foot using the FMS Stym device. Treatment consisted of 12 sessions over 2 weeks, with each session lasting 20 minutes. The manufacturer's preset peripheral neuropathy program was used. Stimulation was continuous and intensity was individually adjusted to produce visible contractions of the intrinsic foot muscles while remaining comfortable. Receives: Device: Functional Magnetic Stimulation |
| Sham Functional Magnetic Stimulation | Sham comparator | Participants underwent the same positioning, treatment schedule, and session procedures as the active stimulation group. A metal plate was placed between the upper support plate and magnetic stimulation head to shield or substantially attenuate the magnetic field reaching the foot. Sessions lasted 20 minutes and were performed 12 times over 2 weeks. Receives: Device: Sham Functional Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Timed Up and Go Completion Time
Participants rose from a chair, walked 3.6 m, turned, walked back to the chair, and sat down. Completion time was recorded in seconds. Lower values indicate better functional mobility.
Measured: Baseline and after 2 weeks of intervention (after 12 sessions)
Change From Baseline in Hallux Grip Force Assessed With the Enhanced Paper Grip Test
Hallux grip force was measured in Newtons using the Enhanced Paper Grip Test. Three measurements were performed for each foot, and the outcome was the average across both feet and three trials. Higher values indicate greater foot grip force.
Measured: Baseline and after 2 weeks of intervention (after 12 sessions)
Secondary outcomes (3)
Change From Baseline in Center-of-Pressure Sway Velocity
Postural sway was assessed during three 30-second barefoot parallel-stance trials on a force platform. Global center-of-pressure sway velocity was expressed in mm/s and averaged across the three trials. Higher values indicate greater postural sway.
Measured: Baseline and after 2 weeks of intervention (after 12 sessions)
Change From Baseline in Semmes-Weinstein Monofilament Total Score
Tactile pressure perception was assessed bilaterally using a 10-g Semmes-Weinstein monofilament at five anatomical sites on each foot. Each site was tested three times. Perceived stimuli were scored 1 and unperceived stimuli 0, giving a total score from 0 to 30. Higher scores indicate better tactile pressure perception
Measured: Baseline and after 2 weeks of intervention (after 12 sessions)
Change From Baseline in Vibration Perception Threshold
Vibration perception threshold was assessed bilaterally at five foot locations using a 100-Hz biothesiometer with an output range of 0-50 V. Lower thresholds indicate better vibration perception. Failure to perceive the maximum 50-V stimulus was classified as an undetected measurement.
Measured: Baseline and after 2 weeks of intervention (after 12 sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start24 Sep 2025
- Primary completion30 Mar 2026
- Study completion25 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Collaborators
- Zdravstevni dom Koper
- Responsible party
- Principal investigator, Nejc Sarabon, University of Primorska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818993
- Sponsor's protocol ID
- FMS_DPN
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The feasibility and conditions for sharing de-identified individual participant data will be determined in accordance with participant consent, ethics approval, applicable data-protection requirements, and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Magnetic Stimulation on Sensory, Motor, and Functional Outcomes in Individuals With Diabetic Peripheral Neuropathy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07818993
- Acronym / sponsor ID
- FMS_DPN
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- functional magnetic stimulation, peripheral magnetic stimulation, plantar sensation, foot strength, diabetic peripheral neuropathy, vibration perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Collaborators
- Zdravstevni dom Koper
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 25 Apr 2026 (actual)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated whether a 2-week course of functional magnetic stimulation applied to the plantar region of the foot could improve sensory function, foot muscle force, postural control, and functional mobility in adults with type 2 diabetes mellitus and diabetic peripheral neuropathy. Participants were assigned to active functional magnetic stimulation or sham stimulation. The study hypothesis was that repeated functional magnetic stimulation would improve sensory and motor function and lead to better functional performance compared with sham stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Magnetic Stimulation | Experimental | Device: Functional Magnetic StimulationParticipants received functional magnetic stimulation applied to the plantar region of the foot using the FMS Stym device. Treatment consisted of 12 sessions over 2 weeks, with each session lasting 20 minutes. The manufacturer's preset peripheral neuropathy program was used. Stimulation was continuous and intensity was individually adjusted to produce visible contractions of the intrinsic foot muscles while remaining comfortable. |
| Sham Functional Magnetic Stimulation | Sham comparator | Device: Sham Functional Magnetic StimulationParticipants underwent the same positioning, treatment schedule, and session procedures as the active stimulation group. A metal plate was placed between the upper support plate and magnetic stimulation head to shield or substantially attenuate the magnetic field reaching the foot. Sessions lasted 20 minutes and were performed 12 times over 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults with type 2 diabetes mellitus and diabetic peripheral polyneuropathy documented in their medical records
- Ability to walk independently with or without an assistive device
- Ability to understand and follow study procedures
Key exclusion criteria (6 listed)
- Conditions that could independently affect balance or foot function
- Contraindications to magnetic stimulation
- Active foot ulceration
- Recent lower-limb injury or surgery
- Severe neurological or musculoskeletal disease unrelated to diabetic peripheral neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Magnetic StimulationPulsed magnetic stimulation was delivered to the plantar region of the foot using the FMS Stym device (Iskra Medical, Slovenia). Participants completed 12 sessions over 2 weeks, each lasting 20 minute | Device | Functional Magnetic Stimulation |
| Sham Functional Magnetic StimulationSham treatment reproduced the positioning, appearance, schedule, and duration of active functional magnetic stimulation while a metal plate substantially attenuated the magnetic field reaching the foo | Device | Sham Functional Magnetic Stimulation |
Primary outcome
Change From Baseline in Timed Up and Go Completion Time
Time frame: Baseline and after 2 weeks of intervention (after 12 sessions)
Participants rose from a chair, walked 3.6 m, turned, walked back to the chair, and sat down. Completion time was recorded in seconds. Lower values indicate better functional mobility.
Change From Baseline in Hallux Grip Force Assessed With the Enhanced Paper Grip Test
Time frame: Baseline and after 2 weeks of intervention (after 12 sessions)
Hallux grip force was measured in Newtons using the Enhanced Paper Grip Test. Three measurements were performed for each foot, and the outcome was the average across both feet and three trials. Higher values indicate greater foot grip force.
3 secondary outcomes
Change From Baseline in Center-of-Pressure Sway Velocity
Time frame: Baseline and after 2 weeks of intervention (after 12 sessions)
Change From Baseline in Semmes-Weinstein Monofilament Total Score
Time frame: Baseline and after 2 weeks of intervention (after 12 sessions)
Change From Baseline in Vibration Perception Threshold
Time frame: Baseline and after 2 weeks of intervention (after 12 sessions)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Undecided. The feasibility and conditions for sharing de-identified individual participant data will be determined in accordance with participant consent, ethics approval, applicable data-protection requirements, and institutional policies.
Related trials for Diabetic Peripheral Neuropathy
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Magnetic Stimulation in people with Diabetic Peripheral Neuropathy, run by University of Primorska at 1 site in Slovenia.
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 3 inclusion and 6 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 14 Sep 2026. 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 Slovenia. 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. Some participants in this study may receive a placebo. 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?
Change From Baseline in Timed Up and Go Completion Time (time frame: Baseline and after 2 weeks of intervention (after 12 sessions)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.