Clinical trial NCT06880484: Far-Infrared Socks for Neuropathic Pain and Nerve Function in Diabetic Patients
Official title: Effect of Far-Infrared Emitting Socks on Neuropathic Pain, Nerve Conduction, and Quality of Life in Patients With Diabetic Peripheral Neuropathy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetic Peripheral Neuropathy (DPN)
Keywords: Diabetic Peripheral Neuropathy
Neuropathic Pain
Far-Infrared Therapy
Infrared Socks
Quality of Life
Diabetes Complications
Non-Pharmacological Treatment
Randomized Controlled Trial
Pain Management
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale
timeFrame: The scale was filled in the baseline
Secondary outcomes:
measure: Neuropathic Pain Impact on Quality of Life (NePIQoL)
timeFrame: The scale was filled in the baseline
Other outcomes:
measure: Change in Electroneuromyography (ENMG) Parameters
timeFrame: Electromyography (EMG) evaluations will be conducted twice during the study
measure: Visual Analog Scale (VAS)
timeFrame: The scale was filled in the baseline
Locations:
city: Talas
country: Turkey
facility: Erciyes Üniversitesi
state: Kayseri
Study officials:
References: