Using infrared thermography and electroacupuncture to prevent diabetic peripheral neuropathy

Early Warning of Diabetic Peripheral Neuropathy by Using Infrared Thermography and the Effectiveness of Electroacupuncture in Its Prevention

This study is testing if using infrared thermography and electroacupuncture can help prevent nerve damage in people with diabetes by looking for early signs and comparing results between those who receive treatment and those who don’t.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Zhejiang Chinese Medical University (Government)
• Locations: 1 site (Hanzhou, Zhejiang)
• Trial ID: NCT06074913 on ClinicalTrials.gov

What this trial studies

This study aims to analyze temperature changes in the feet and hands of healthy individuals and diabetic patients using infrared thermography to identify early signs of diabetic peripheral neuropathy (DPN). It will also evaluate the effectiveness of electroacupuncture in preventing DPN by comparing outcomes between a treatment group and a waiting list group. The study will assess various nerve function metrics and blood glucose levels to determine the impact of electroacupuncture on nerve health. A total of 50 diabetic subjects will be enrolled and randomized for this intervention.

Who should consider this trial

Good fit: Ideal candidates include diabetic patients aged 18 to 85 who have normal nerve conduction and no serious underlying health conditions.

Not a fit: Patients with significant nerve conduction issues or serious comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel preventive approach to diabetic peripheral neuropathy, potentially improving quality of life for diabetic patients.

How similar studies have performed: While electroacupuncture has shown promise in improving nerve function, this specific preventive approach for DPN is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Part Ⅰ：

Inclusion criteria for healthy subjects:

1. Routine physical examination by the investigator to confirm the absence of heart and lung diseases, and the absence of serious underlying diseases such as digestive, urinary, haematological, endocrine, and neurological systems;
2. 18 years old ≤ age ≤ 85 years old, gender is not limited;
3. Have normal communication ability;
4. Those who have a sense of autonomy and independence, voluntarily submit to the study protocol and sign the informed consent form.

Inclusion criteria for diabetic patients

1. 18 ≤ age ≤ 85 years old, with any disease duration and any gender;
2. Lower limb nerve electromyography shows no slowing of conduction velocity;
3. Normal communication ability;
4. No serious heart, brain, liver, kidney and other internal diseases, no serious mental illness and cognitive impairment;
5. Those who have a sense of autonomy and independence, voluntarily submit to the study protocol, and sign the informed consent form.

Inclusion criteria for mild DPN patients

1. 18 years ≤ age ≤ 85 years with any disease duration and any gender;
2. Clear history of diabetes mellitus;
3. Lower limb nerve EMG showing reduced conduction velocity, and/or persistent pain and/or sensory abnormalities in the extremities (at least in both lower limbs), diminished ankle reflexes bilaterally or unilaterally, and diminished vibration sensation;
4. TCSS score of 6-8;
5. Have normal communication skills;
6. No serious heart, brain, liver, kidney and other medical disorders, no serious mental illness and cognitive impairment;
7. Those who have a sense of autonomy and independence, voluntarily submit to the study protocol, and sign the informed consent form.

   * Part Ⅱ：

Inclusion Criteria:

1. 18 years ≤ age ≤ 85 years with any disease duration and any gender;
2. Those with changes in thermal characteristics for early warning of DPN patients according to Part Ⅰ; (3) Those whose lower limb neuromuscular electromyography shows no slowing of conduction velocity; (4) Those with normal communication skills; (5) No serious heart, brain, liver, kidney and other internal diseases, no serious mental illness and cognitive impairment; (6) Have a sense of autonomy and independence, voluntarily submit to the study protocol, and sign the informed consent form.

Exclusion Criteria:

* Part Ⅰ： Exclusion criteria for healthy subjects

  1. Those with severe mental illness, depression, alcohol dependence, or a history of substance abuse;
  2. Volunteers who are in preparation for pregnancy, pregnant or breastfeeding;
  3. Volunteers who are participating in other interventional clinical trials;
  4. Those who have scars, hyperpigmentation, redness, swelling and heat pain on the skin at the testing site, thus affecting the accuracy of the test.

Exclusion criteria for diabetic patients

1. Persons with severe mental illness, depression, alcohol dependence, or a history of substance abuse;
2. Volunteers who are in preparation for pregnancy, pregnant or breastfeeding;
3. Those with acute complications such as combined diabetic ketoacidosis, peripheral neuropathy, lactic acidosis, and severe infections;
4. Volunteers who are participating in other interventional clinical trials;
5. Those who have scars, hyperpigmentation, redness, swelling and heat pain on the skin at the testing site, thus affecting the accuracy of the test.

Exclusion criteria for mild DPN patients

1. TCSS score \> 8;
2. Those with peripheral neuropathy, ulcers and gangrene of the extremities due to various other causes (e.g., hypothyroidism, alcohol, drugs, heredity, etc.) or those with a history of skin ulceration or lesions that do not heal easily;
3. Women who are in preparation for pregnancy, during pregnancy, or breastfeeding;
4. Those with acute complications such as combined lactic acidosis and severe infections;
5. Those who suffer from serious liver or kidney damage or serious cardiovascular diseases and cannot take care of themselves;
6. Those who have scars or pigmentation on the skin at the testing site, which affects the accuracy of the test;

   * Part Ⅱ：

Exclusion Criteria:

(1) Those with severe mental illness, depression, alcohol dependence, or a history of substance abuse; (2) Volunteers who are in preparation for pregnancy, pregnant or breastfeeding; (3) Those with acute complications such as combined diabetic ketoacidosis, diagnosed DPN, lactic acidosis, and severe infections; (4) Those with no change in thermal characteristics for early warning of DPN patients according to the results of the Part Ⅰ; (5) Those with liver or kidney damage or cardiovascular diseases (angina pectoris, myocardial infarction, multiple cerebral infarction, cerebral haemorrhage, etc.) resulting in severe sequelae; (6) Volunteers who are participating in other interventional clinical trials; (7) Those who have scars, hyperpigmentation, redness, swelling and heat pain on the skin at the testing site, thus affecting the accuracy of the test.

Where this trial is running

Hanzhou, Zhejiang

• the Third affiliated hospital of Zhejiang Chinese Medical university — Hanzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Jianqiao Fang — The Third Clinical Medical College of Zhejiang Chinese Medical University
• Study coordinator: Jianqiao Fang

Conditions Diabetic Peripheral Neuropathy; Diabetes; Electroacupuncture