Status:
UNKNOWN
Early Warning of Diabetic Peripheral Neuropathy by Using Infrared Thermography and the Effectiveness of Electroacupuncture in Its Prevention
Lead Sponsor:
Zhejiang Chinese Medical University
Conditions:
Diabetic Peripheral Neuropathy
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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...
Detailed Description
Part Ⅰ: We analyse and compare the change rules of average temperature in each area of the three groups of patients, explore the correlation between the temperature in each area of mild DPN patients a...
Eligibility Criteria
Inclusion
- Part Ⅰ：
- Inclusion criteria for healthy subjects:
- 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;
- 18 years old ≤ age ≤ 85 years old, gender is not limited;
- Have normal communication ability;
- 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
- 18 ≤ age ≤ 85 years old, with any disease duration and any gender;
- Lower limb nerve electromyography shows no slowing of conduction velocity;
- Normal communication ability;
- No serious heart, brain, liver, kidney and other internal diseases, no serious mental illness and cognitive impairment;
- 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
- 18 years ≤ age ≤ 85 years with any disease duration and any gender;
- Clear history of diabetes mellitus;
- 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;
- TCSS score of 6-8;
- Have normal communication skills;
- No serious heart, brain, liver, kidney and other medical disorders, no serious mental illness and cognitive impairment;
- Those who have a sense of autonomy and independence, voluntarily submit to the study protocol, and sign the informed consent form.
- Part Ⅱ：
- 18 years ≤ age ≤ 85 years with any disease duration and any gender;
- 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
- Part Ⅰ： Exclusion criteria for healthy subjects
- Those with severe mental illness, depression, alcohol dependence, or a history of substance abuse;
- Volunteers who are in preparation for pregnancy, pregnant or breastfeeding;
- Volunteers who are participating in other interventional clinical trials;
- 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
- Persons with severe mental illness, depression, alcohol dependence, or a history of substance abuse;
- Volunteers who are in preparation for pregnancy, pregnant or breastfeeding;
- Those with acute complications such as combined diabetic ketoacidosis, peripheral neuropathy, lactic acidosis, and severe infections;
- Volunteers who are participating in other interventional clinical trials;
- 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
- TCSS score \> 8;
- 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;
- Women who are in preparation for pregnancy, during pregnancy, or breastfeeding;
- Those with acute complications such as combined lactic acidosis and severe infections;
- Those who suffer from serious liver or kidney damage or serious cardiovascular diseases and cannot take care of themselves;
- Those who have scars or pigmentation on the skin at the testing site, which affects the accuracy of the test;
- Part Ⅱ：
Key Trial Info
Start Date :
July 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06074913
Start Date
July 7 2023
End Date
December 1 2025
Last Update
October 10 2023
Active Locations (1)
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1
the Third affiliated hospital of Zhejiang Chinese Medical university
Hanzhou, Zhejiang, China