None listed
Conditions
Interventions
Medical Device : 1) Test Device
- Item Name: Transcutaneous Electrical Stimulation Device for Pain Relief
- Purpose of Use: This product is intended to alleviate diabetic peripheral neuropathy pain in
the principle applied is to alleviate pain by simultaneously delivering frequencies corresponding to specific lesions or conditions through one channel and frequencies corresponding to specific tissue
Sponsors
Mediver Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects participating in this clinical trial must satisfy all of the following selection criteria: 1) At least 18 years of age and no more than 80 years of age as of the date of written consent 2) Meeting one of the following criteria: i. Having a history of diabetes mellitus and confirmed symptoms of symmetrical peripheral neuropathy (numbness, pain, reduced sensation) in both hands or feet ii. Individuals whose diagnosis is clinically confirmed based on standardized assessment scales (Michigan Neuropathy Screening Instrument - MNSI, Neuropathy Disability Score - NDS) and physical examination (10g monofilament, vibration sense test, ankle reflex, etc.) in accordance with ADA guidelines, or whose peripheral neuropathy is confirmed by electrodiagnostic tests. 3) Individuals with HbA1c < 8% 4) Individuals with peripheral neuropathic pain lasting for at least 3 months and a VAS score of 40 or higher during screening. However, if pain is present in both the hands and feet, the site exhibiting the highest pain intensity during screening shall be designated as the index site and index VAS. 5) Those who can faithfully adhere to the scheduled visits during the clinical trial period 6) Those whose dosage and type of pain-related medication (including antidepressants and anticonvulsants) currently being taken have been maintained stably without change for at least the past 3 months and have no plans to change them during the clinical trial period 7) For women of childbearing age, those who agree to and can observe appropriate contraception methods during the clinical trial period (1 month) Appropriate contraception methods refer to one or more of the following: i. Hormonal contraception methods such as oral contraceptives, intrauterine devices, subcutaneous implants, or contraceptive injections ii. Barrier methods using condoms (male or female) (spermicides may be used in combination if necessary) iii. Permanent contraception methods such as vasectomy by a partner or tubal ligation by the woman herself iv. Maintaining a state of abstinence (abstinence) during the clinical trial period
Exclusion criteria
Exclusion criteria: Subjects meeting the following exclusion criteria are not eligible to participate in this clinical trial. 1) Individuals whose primary pain is pain other than diabetic peripheral neuropathy (e.g., musculoskeletal pain, fibromyalgia, etc.) 2) Individuals with severe sequelae of diabetes (if any of the following apply): i. Severe eye disease: Currently undergoing treatment or recently deemed to require treatment for proliferative diabetic retinopathy, diabetic macular edema, etc., or when evaluation/adherence is difficult due to moderate to severe visual impairment ii. Diabetic foot/foot complications: Active, open foot ulcer, gangrene, severe infection, or cases requiring treatment iii. Cases with severe peripheral vascular disease, such as a history of angioplasty, peripheral bypass surgery, or claudication within 6 months of the screening visit 3) Individuals unlikely to survive during the study period due to severe underlying conditions (e.g., advanced cancer, heart failure, respiratory failure, liver failure, renal failure [CrCl=30 mL/min], etc.) or cases where the principal investigator determines that life expectancy is limited 4) Individuals who have undergone interventional procedures (nerve block, radiofrequency ablation, epidural injection, etc.) for pain control within the last 30 days 5) Individuals with severe skin diseases or infections, or wounds at the electrode attachment site of the investigational medical device 6) Patients with acute or severe pain (VAS = 70 points) 7) Individuals with implanted electronic devices (e.g., pacemakers, implantable cardioverter-defibrillators, etc.) 8) Individuals with a history of active seizures or uncontrolled epilepsy 9) Pregnant or breastfeeding Female 10) Individuals who have difficulty participating in the study or communicating effectively due to cognitive decline. 11) Patients with primary insomnia that has persisted prior to the onset of peripheral neuropathy. 12) Individuals currently being treated for a severe psychiatric disorder (e.g., major depressive disorder, anxiety disorder, psychotic disorder) or whose pain is judged to be primarily caused by psychopsychological factors. 13) Individuals with hypersensitivity, severe side effects, or contraindications to rescue medications (Gabapentin, Pregabalin). 14) Individuals with a BDI score of 22 or higher or a PSQI score of 8.5 or higher as administered at Visit 2. 15) Patients with severe sensory loss in the affected body part, regardless of the cause. 16) Individuals requiring continuous administration of high-dose anticoagulants or high-dose antiplatelet agents. 17) Individuals with underlying conditions posing a risk of hemorrhage. 18) Any other individuals deemed unsuitable for participation in this clinical trial by the Principal Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 100mm VAS(Visual Analogue Scale) score from baseline;Treatment-Emergent Adverse Event;Vital Signs and Physical Examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in 100mm VAS(Visual Analogue Scale) score from baseline;Change in total NPSI(Neuropathic Pain Symptom Inventory) score compared to baseline;Change in NPSI(Neuropathic Pain Symptom Inventory) sub-area evaluation scores compared to baseline;Change in SF-36 (Short Form-36) Quality of Life Score from Baseline;Change in BDI(Beck Depression Inventory) scores compared to baseline;Change in PSQI (Pittsburgh Sleep Quality Index) score compared to baseline;Changes in rescue medication use compared to baseline (number of patients taking rescue medication, type of medication, frequency of use, dosage) | — |
Countries
Korea, Republic of
Contacts
Public Contactsunhee Lee
Mediver Inc.
Outcome results
None listed