Far-Infrared Socks for Neuropathic Pain and Nerve Function in Diabetic Patients (NCT06880484) | Clinical Trial Compass
By InvitationNot Applicable
Far-Infrared Socks for Neuropathic Pain and Nerve Function in Diabetic Patients
Turkey (Türkiye)50 participantsStarted 2025-02-02
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, br…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale