Overview

Part Ⅰ:Infrared thermograms of four parts of the soles of the feet, dorsum of the feet, palms of the hands, and dorsum of the hands of healthy volunteers, diabetic patients, and patients with diabetic peripheral neuropathy were collected by using infrared thermography, and the patterns of change in the average temperatures of the parts of the participants in the three groups were analysed and compared by using the accompanying software.

Part Ⅱ: Diabetic Peripheral Neuropathy (DPN) mainly presents with symmetrical pain,numbness, and ankylosing sensation, but reversal after diagnosis is particularly difficult. Electroacupuncture can significantly improve the function of peripheral nerves, regulate local blood flow, and reduce the inflammatory response to promote nerve regeneration, but no study has shown that electroacupuncture can effectively prevent the occurrence of DPN. Therefore, it is of great research significance to determine whether electroacupuncture has the possibility in preventing the occurrence of DPN.

Eligibility

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.