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

Launched by ZHEJIANG CHINESE MEDICAL UNIVERSITY · Oct 5, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring two main things related to a condition called Diabetic Peripheral Neuropathy (DPN), which can cause pain, numbness, and discomfort in the feet and hands of people with diabetes. First, the researchers are using a special technique called infrared thermography to look at temperature changes in the feet and hands of healthy individuals, those with diabetes, and those already experiencing DPN. This may help in identifying early signs of DPN. Second, the trial is investigating whether a treatment called electroacupuncture can help prevent DPN from developing in people who are at risk.

To participate in the trial, individuals must be between 18 and 85 years old and have no serious health issues that could interfere with the study. Healthy volunteers, diabetic patients, and patients with mild DPN may all be eligible. Participants can expect to undergo assessments, including temperature scans and possibly electroacupuncture treatments, while contributing to important research that could lead to better prevention and management of DPN. It's important to note that certain individuals, such as those with severe mental health issues or other serious medical conditions, may not be eligible to join the study.

Gender

ALL

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.