Diabetic Peripheral Neuropathy (DPN)FIR-DPNNCT06880484
Far-Infrared Socks for Neuropathic Pain and Nerve Function in Diabetic Patients
A study testing Far-Infrared Radiation (FIR) Socks in people with Diabetic Peripheral Neuropathy (DPN), run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathy (DPN)
- What is being tested?
- Far-Infrared Radiation (FIR) Socks
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Body Mass Index (BMI) between 25 - 35.
- Able to be contacted by phone for follow-up.
- Willing to participate and provide informed consent.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Being tested
- Far-Infrared Radiation (FIR) Socks, Placebo Socks
- Keywords
- Diabetic Peripheral Neuropathy, Neuropathic Pain, Far-Infrared Therapy, Infrared Socks, Quality of Life, Diabetes Complications, Non-Pharmacological Treatment, Randomized Controlled Trial, Pain Management
- Medical subject headings
- Neuralgia, Diabetes Complications, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far-Infrared Radiation (FIR) SocksDevice
Also called Far-Infrared Therapy Socks
Participants in the experimental group will receive two pairs of Far-Infrared Radiation (FIR) emitting socks, designed to be worn for at least 8 hours per day over a 3-month period. These socks utilize FIR technology, which is hypothesized to improve circulation, reduce neuropathic pain, and enhance quality of life in patients with diabetic peripheral neuropathy (DPN). Participants will be educated on the proper use of the socks, provided with a usage protocol, and monitored for adherence via three follow-up phone calls assessing compliance and comfort using the Visual Analog Scale (VAS). At the end of the study, participants will undergo a follow-up Electroneuromyography (ENMG) evaluation, and pain and quality of life will be reassessed using the LANSS Scale and NePIQoL forms.
Placebo SocksDevice
Also called Non-FIR Socks
Participants in the placebo group will receive two pairs of non-FIR socks, which are visually identical to the FIR socks but lack FIR-emitting properties. They will follow the same 8-hour daily usage protocol for 3 months and receive the same education on sock usage. Compliance and comfort will be monitored through three follow-up phone calls, and assessments will be conducted using the VAS, LANSS Scale, and NePIQoL forms. At the end of the study, participants will undergo a final ENMG evaluation.This study aims to determine the effect of FIR socks on neuropathic pain, nerve conduction, and quality of life, using both subjective (pain scales) and objective (ENMG) measures.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Device: Far-Infrared Radiation (FIR) Socks |
| Placebo Socks Group | Placebo comparator | 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. Receives: Device: Placebo Socks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale
The Leeds Neuropathic Symptoms and Signs Assessment Scale (LANSS) was developed by Bennett (2001) and its Turkish validity and reliability study was conducted by Yücel et al. (2004). It is used clinically to differentiate neuropathic pain from nociceptive pain and consists of a five-item pain questionnaire (max: 16 points) and a two-item sensory assessment (max: 24 points). The pain questionnaire evaluates symptoms like tingling, paresthesia, skin color changes, electric shock sensations, and burning pain. The sensory section includes Allodynia and Pinprick tests; in the Allodynia test, a cotton wisp is applied to painful and non-painful areas-if discomfort is reported in the affected region, allodynia is considered present. If the total score is ≥12, pain is classified as neuropathic, while a score <12 indicates nociceptive pain. The scale has 82-91% sensitivity and 80-94% specificity when compared to clinical diagnosis.
Measured: The scale was filled in the baseline
Secondary outcomes (1)
Neuropathic Pain Impact on Quality of Life (NePIQoL)
The Neuropathic Pain Impact on Quality of Life Questionnaire (NePIQoL) was developed by Poole et al. (2009) to assess the impact of neuropathic pain on quality of life. The Turkish validity and reliability study was conducted by Acar et al. (2016) (Acar et al., 2016; Poole et al., 2009). In the original study, the internal consistency of the total NePIQoL was reported as 0.86, while in the validity and reliability study, it was found to be 0.99. The scale consists of five subdimensions: pain and other symptoms, relationships, daily activities, emotional impact of pain, and personal/self-care. It is a 42-item, 5-point Likert-type scale. The minimum possible score on the questionnaire is 42, while the maximum is 210. A score closer to 210 indicates a greater negative impact of neuropathic pain on quality of life. Conversely, lower scores reflect a better quality of life with less impact from neuropathic pain.
Measured: The scale was filled in the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start2 Feb 2025
- Primary completion3 Feb 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathy (DPN)Studies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harun İN, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880484
- Sponsor's protocol ID
- 1782/1762
- Other IDs
- 1782/1762
- Acronym
- FIR-DPN
- Status last verified
- Mar 2025
- First submitted
- 4 Feb 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06880484
- Acronym / sponsor ID
- FIR-DPN / 1782/1762
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 3 Feb 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Far-Infrared Radiation (FIR) SocksPatients 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. |
| Placebo Socks Group | Placebo comparator | Device: Placebo SocksPlacebo 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Far-Infrared Radiation (FIR) SocksAlso: Far-Infrared Therapy SocksParticipants in the experimental group will receive two pairs of Far-Infrared Radiation (FIR) emitting socks, designed to be worn for at least 8 hours per day over a 3-month period. These socks utilize FIR technology, which is hypothesized to improve circulation, reduce neuropathic pain, and enhance quality of life in patients with diabetic peripheral neuropathy (DPN). Participants will be educated on the proper use of the socks, provided with a usage protocol, and monitored for adherence via three follow-up phone calls assessing compliance and comfort using the Visual Analog Scale (VAS). At the end of the study, participants will undergo a follow-up Electroneuromyography (ENMG) evaluation, and pain and quality of life will be reassessed using the LANSS Scale and NePIQoL forms. | Device | Experimental Group |
| Placebo SocksAlso: Non-FIR SocksParticipants in the placebo group will receive two pairs of non-FIR socks, which are visually identical to the FIR socks but lack FIR-emitting properties. They will follow the same 8-hour daily usage protocol for 3 months and receive the same education on sock usage. Compliance and comfort will be monitored through three follow-up phone calls, and assessments will be conducted using the VAS, LANSS Scale, and NePIQoL forms. At the end of the study, participants will undergo a final ENMG evaluation.This study aims to determine the effect of FIR socks on neuropathic pain, nerve conduction, and quality of life, using both subjective (pain scales) and objective (ENMG) measures. | Device | Placebo Socks Group |
Primary outcome
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale
Time frame: The scale was filled in the baseline
The Leeds Neuropathic Symptoms and Signs Assessment Scale (LANSS) was developed by Bennett (2001) and its Turkish validity and reliability study was conducted by Yücel et al. (2004). It is used clinically to differentiate neuropathic pain from nociceptive pain and consists of a five-item pain questionnaire (max: 16 points) and a two-item sensory assessment (max: 24 points). The pain questionnaire evaluates symptoms like tingling, paresthesia, skin color changes, electric shock sensations, and burning pain. The sensory section includes Allodynia and Pinprick tests; in the Allodynia test, a cotton wisp is applied to painful and non-painful areas-if discomfort is reported in the affected region, allodynia is considered present. If the total score is ≥12, pain is classified as neuropathic, while a score <12 indicates nociceptive pain. The scale has 82-91% sensitivity and 80-94% specificity when compared to clinical diagnosis.
1 secondary outcome
Neuropathic Pain Impact on Quality of Life (NePIQoL)
Time frame: The scale was filled in the baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Far-Infrared Radiation (FIR) Socks in people with Diabetic Peripheral Neuropathy (DPN), run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale (time frame: The scale was filled in the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.