A study to explore whether using a home-based electrical stimulation device on the feet and abdomen for 12 weeks can improve nerve function in patients with diabetic peripheral neuropathy

Effects of Abdominal and Plantar Neuromuscular Electrical Stimulation (NMES) on Nerve Function in Patients with Diabetic Peripheral Neuropathy: A 12-Week Single-Arm Exploratory Pre-Post Clinical Trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0012019

Enrollment

Registered

2026-05-21

Start date

2026-05-28

Completion date

Unknown

Last updated

2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : ? Investigational Device Device name: TRYCAM-Cube (Low-frequency electrical stimulator) Manufacturer: Trycam Technology Co., Ltd. (Republic of Korea) Device classification: Class II m

maximum surface temperature =45°C ? Administration and Duration Setting: Home-based, self-administered by participant Frequency: Once daily Total intervention period: 12 weeks Visit schedule: 3 outpat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults aged 19 to 75 years with diabetic peripheral neuropathy (DPN), who have experienced neuropathic symptoms for at least 6 months, have an MNSI(A) score of =7, meet the criteria for confirmed DPN according to the Toronto Diabetic Neuropathy Expert Group, are able to undergo a 12-week intervention and follow-up, and provide voluntary informed consent.

Exclusion criteria

Exclusion criteria: Patients with foot ulcers or infection, those with implanted electronic devices (e.g., pacemakers), severe peripheral arterial disease (ABI < 0.5), neuropathy due to non-diabetic causes, pregnant or breastfeeding women, and those with skin lesions on the abdomen or plantar surface of the foot.

Design outcomes

Primary

Measure	Time frame
Nerve conduction study (NCS) is performed on four lower limb peripheral nerves: sural nerve, superficial peroneal nerve, deep peroneal nerve, and tibial nerve. The following parameters are assessed: Sensory nerve action potential (SNAP) amplitude: sural nerve, superficial peroneal nerve Compound muscle action potential (CMAP) amplitude: deep peroneal nerve, tibial nerve Nerve conduction velocity (NCV): all four nerves Distal latency: all four nerves Absent response: recorded where applicable The primary efficacy endpoint is sural nerve SNAP amplitude. Remaining parameters are used for exploratory analysis. Abnormality is defined based on age- and height-adjusted normative reference values established at the study site.	—

Measure

Time frame

Nerve conduction study (NCS) is performed on four lower limb peripheral nerves: sural nerve, superficial peroneal nerve, deep peroneal nerve, and tibial nerve. The following parameters are assessed: Sensory nerve action potential (SNAP) amplitude: sural nerve, superficial peroneal nerve Compound muscle action potential (CMAP) amplitude: deep peroneal nerve, tibial nerve Nerve conduction velocity (NCV): all four nerves Distal latency: all four nerves Absent response: recorded where applicable The primary efficacy endpoint is sural nerve SNAP amplitude. Remaining parameters are used for exploratory analysis. Abnormality is defined based on age- and height-adjusted normative reference values established at the study site.

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Secondary

Measure	Time frame
The Michigan Neuropathy Screening Instrument (MNSI) is used to evaluate symptoms and signs of diabetic peripheral neuropathy. Part A (Self-report questionnaire): A 15-item patient-administered questionnaire assessing neuropathic symptoms including numbness, burning, pain, and sensory loss in the feet. Scored out of 13; higher scores indicate greater symptom burden. Part B (Physical examination): A clinician-administered examination assessing foot appearance, ulceration, reflexes, and vibration perception. Scored out of 10; higher scores indicate more severe neuropathic signs. Changes in both Part A and Part B scores from baseline to Week 12 are analyzed as secondary endpoints.;The Visual Analogue Scale (VAS) is used to assess the intensity of neuropathic pain in the lower extremities due to diabetic peripheral neuropathy. A 100mm horizontal scale is used, where 0mm represents "no pain" and 100mm represents "the worst imaginable pain." Participants mark the point corresponding to their current level of neuropathic pain in the feet and lower limbs. The distance from the left end to the mark is recorded in millimeters. Lower scores indicate greater pain relief. Change in VAS score from baseline to Week 12 is analyzed as a secondary endpoint.;Laser Doppler Flowmetry (LDF) is used to assess changes in peripheral microvascular blood flow in the lower extremities. A laser Doppler probe is applied to the skin of the distal lower limb (dorsum of the foot or toe) to measure the velocity of red blood cells within the cutaneous microvasculature. Results are recorded in Perfusion Units (PU). LDF directly reflects endoneurial microvascular impairment, a key pathophysiological mechanism in DPN, and is used as a secondary endpoint to explore the mechanistic link between NMES-induced circulatory improvement and nerve recovery. Measurements are performed in a temperature-controlled room (22±2°C) after at least 10 minutes of supine rest.;The Ankle-Brachial Index (ABI) is measured t	—

Measure

Time frame

The Michigan Neuropathy Screening Instrument (MNSI) is used to evaluate symptoms and signs of diabetic peripheral neuropathy. Part A (Self-report questionnaire): A 15-item patient-administered questionnaire assessing neuropathic symptoms including numbness, burning, pain, and sensory loss in the feet. Scored out of 13; higher scores indicate greater symptom burden. Part B (Physical examination): A clinician-administered examination assessing foot appearance, ulceration, reflexes, and vibration perception. Scored out of 10; higher scores indicate more severe neuropathic signs. Changes in both Part A and Part B scores from baseline to Week 12 are analyzed as secondary endpoints.;The Visual Analogue Scale (VAS) is used to assess the intensity of neuropathic pain in the lower extremities due to diabetic peripheral neuropathy. A 100mm horizontal scale is used, where 0mm represents "no pain" and 100mm represents "the worst imaginable pain." Participants mark the point corresponding to their current level of neuropathic pain in the feet and lower limbs. The distance from the left end to the mark is recorded in millimeters. Lower scores indicate greater pain relief. Change in VAS score from baseline to Week 12 is analyzed as a secondary endpoint.;Laser Doppler Flowmetry (LDF) is used to assess changes in peripheral microvascular blood flow in the lower extremities. A laser Doppler probe is applied to the skin of the distal lower limb (dorsum of the foot or toe) to measure the velocity of red blood cells within the cutaneous microvasculature. Results are recorded in Perfusion Units (PU). LDF directly reflects endoneurial microvascular impairment, a key pathophysiological mechanism in DPN, and is used as a secondary endpoint to explore the mechanistic link between NMES-induced circulatory improvement and nerve recovery. Measurements are performed in a temperature-controlled room (22±2°C) after at least 10 minutes of supine rest.;The Ankle-Brachial Index (ABI) is measured t

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Countries

Korea, Republic of

Contacts

Public ContactSu Geun Kim

Seoul National University Bundang Hospital

iamsugeun@naver.com+82-31-787-8232

Outcome results