Far-infrared socks for nerve pain in people with diabetic neuropathy

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with mild to moderate nerve damage in the feet and legs caused by diabetes (diabetic peripheral neuropathy). They will wear special far-infrared socks or look-alike placebo socks daily.

Age

19 years and older

Sex

All sexes

Disease stage

Diabetic peripheral neuropathy of mild to moderate severity, based on clinical evaluation. People must live in Kayseri and get treatment there.

Earlier treatment

No neuropathic pain medicine for at least 3 months before joining. No non-drug treatment for the neuropathy. No recent changes in diabetes medicine.

Biomarker or test result

HbA1C below 8.5% (69 mmol/mol) during the study. BMI between 25 - 35. Non-smoker for at least 6 months.

Main reasons for not taking part

• Diabetic foot ulcers, or unable to walk on your own
• Severe artery disease in the legs (Ankle Brachial Index below 0.4), or coronary artery disease
• Liver failure or kidney failure (on dialysis)
• Dementia or other nerve or memory problems, or chronic alcohol or drug use
• Pregnant, breastfeeding or trying to get pregnant

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• Experimental GroupTreatment being tested

  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: Far-Infrared Radiation (FIR) Socks

• Placebo Socks GroupPlacebo, for comparison

  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: Placebo Socks