Far-Infrared Socks for Neuropathic Pain and Nerve Function in Diabetic Patients (FIR-DPN)

TC Erciyes University

Status: Invitation-only

Conditions: Diabetic Peripheral Neuropathy (DPN)

Treatments: Device: Placebo Socks; Device: Far-Infrared Radiation (FIR) Socks

Study type: Interventional

Funder types: Other

Identifiers

NCT06880484

1782/1762 (Other Identifier)

Details and patient eligibility

About

This study aims to evaluate the effectiveness of far-infrared radiation (FIR) emitting socks in improving neuropathic pain, nerve conduction, and quality of life in patients with diabetic peripheral neuropathy (DPN). It is the first comprehensive study in Turkey investigating FIR technology for DPN treatment and offers an alternative approach to traditional methods.The study will be conducted at Erciyes University Gevher Nesibe Hospital between February 2025 and June 2026 as a randomized controlled trial (RCT) with a triple-blind design. Participants will be assigned to either the FIR socks group or the placebo group, with both groups receiving two pairs of socks to wear daily. Assessments will include the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale, the Neuropathic Pain Impact on Quality of Life (NePIQoL) questionnaire, and the Visual Analog Scale (VAS) for patient-reported outcomes. Electroneuromyography (ENMG) testing will also be performed before and after the intervention to assess nerve function.

This research is expected to provide clinical evidence on FIR socks as a non-pharmacological treatment for neuropathic pain, contributing to improved patient care and the development of innovative medical technologies in Turkey.

Enrollment: 50 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with diabetic peripheral neuropathy (DPN) with mild to moderate severity based on clinical evaluation.
• Oriented to person, place, and time (cognitively intact).
• Residing in Kayseri and receiving treatment in the city.
• HbA1C level below 8.5% during the study period.
• Non-smoker for at least 6 months.
• Not using neuropathic pain medication for at least 3 months before enrollment.
• Body Mass Index (BMI) between 25 - 35.
• Able to be contacted by phone for follow-up.
• Willing to participate and provide informed consent.

Exclusion criteria

• Presence of diabetic foot ulcers.
• Non-mobilized individuals (unable to walk independently).
• Severe peripheral artery disease (Ankle Brachial Index (ABI) < 0.4).
• Liver failure or renal failure (dialysis patients).
• Coronary artery disease.
• Candidates for surgery during the intervention period.
• Lower extremity arthroplasty or orthosis indication during the intervention period.
• Neurological or cognitive impairments (e.g., dementia, Alzheimer's disease).
• Receiving non-pharmacological treatment for diabetic peripheral neuropathy (DPN).
• Chronic alcohol or substance use.
• Severe anemia, vitamin B12 deficiency, or iron deficiency anemia.
• Recent changes in diabetes medication or newly diagnosed with diabetes.
• Neurological, cardiovascular, or orthopedic damage affecting the lower extremities.
• Use of cytotoxic or immunosuppressive agents or history of radiation therapy.
• Pregnant, breastfeeding, or attempting to conceive.
• Receiving physiotherapy at any point during the study period.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

Patients will be selected from those attending endocrinology and neurology clinics or hospitalized and meeting the inclusion criteria. Participants will complete the Patient Information Form, LANSS Scale, and NePIQoL forms in a quiet room in the endocrinology ward. The Ankle Brachial Index will be evaluated to exclude peripheral arterial disease. If ENMG and lab findings are unavailable, patients will be referred for necessary tests. They will receive two pairs of FIR socks to be worn at least 8 hours daily, along with usage training. Contact information will be collected. Participants will be called three times to assess compliance and comfort via VAS. After three months, they will return for a final evaluation, including an ENMG scan by neurology specialists, and complete the LANSS Scale and NePIQoL forms again.

Treatment:

Device: Far-Infrared Radiation (FIR) Socks

Placebo Socks Group

Placebo Comparator group

Description:

Placebo group patients will be selected from those attending endocrinology and neurology clinics or hospitalized and meeting inclusion criteria. Participants will complete the Patient Information Form, LANSS Scale, and NePIQoL forms in a quiet room. The Ankle Brachial Index will be evaluated to exclude peripheral arterial disease. If ENMG and lab findings are unavailable, patients will be referred for necessary tests. They will receive two pairs of non-FIR socks to be worn at least 8 hours daily, along with usage training. Contact information will be collected. Participants will be called three times to assess compliance and comfort via VAS. After three months, they will return for a final evaluation, including an ENMG scan by neurology specialists, and complete the LANSS Scale and NePIQoL forms again.

Treatment:

Device: Placebo Socks