Early Warning of Diabetic Peripheral Neuropathy by Using Infrared Thermography and the Effectiveness of Electroacupuncture in Its Prevention
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetic Peripheral Neuropathy
- Sponsor
- Zhejiang Chinese Medical University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Temperature of the palm
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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 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.
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 and the duration of the disease, age, BMI, etc., and explore the optimal prediction threshold for the occurrence of DPN, as well as its sensitivity and specificity. Part Ⅱ: A total of 50 diabetic subjects meeting the inclusion criteria will be enrolled in the study and randomised into the EA group and the waiting list group using envelope randomisation. The indexes of main outcome evaluation are: change in regional temperature. The indexes of secondary outcome evaluation are: 1) sensory nerve amplitude and conduction velocity (SNCV) of the tibial and peroneal nerves of the lower extremities, and motor nerve amplitude and conduction velocity (MNCV). 2) change in TCSS score, and 3) laboratory tests (glycated haemoglobin, fasting blood glucose, and postprandial 2h blood glucose). This study will evaluate the effectiveness of EA in preventing DPN.
Investigators
Jianqiao Fang
professor
Zhejiang Chinese Medical University
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Temperature of the palm
Time Frame: Baseline, 6 weeks
Participants in part 1 and part 2 were tested, but participants in part 1 were tested only once at enrolment and patients in part 2 were tested once before and once after treatment.
Temperature of the back of the hand
Time Frame: Baseline, 6 weeks
Participants in part 1 and part 2 were tested, but participants in part 1 were tested only once at enrolment and patients in part 2 were tested once before and once after treatment.
Temperature of the soles of the feet
Time Frame: Baseline, 6 weeks
Participants in part 1 and part 2 were tested, but participants in part 1 were tested only once at enrolment and patients in part 2 were tested once before and once after treatment.
Temperature of the instep
Time Frame: Baseline, 6 weeks
Participants in part 1 and part 2 were tested, but participants in part 1 were tested only once at enrolment and patients in part 2 were tested once before and once after treatment.
Secondary Outcomes
- Electromyogram examination-Sensory conduction velocity of sural nerve(Baseline, 6 weeks)
- Fasting blood glucose (FPG)(Baseline, 6 weeks)
- Electromyogram examination-Sensory conduction velocity of superficial peroneal nerve(Baseline, 6 weeks)
- Electromyogram examination-Motor conduction velocity of tibial nerve(Baseline, 6 weeks)
- Toronto clinical scoring system(Baseline, 6 weeks)
- Electromyogram examination-Motor conduction velocity of Peroneal nerve(Baseline, 6 weeks)
- Glycated haemoglobin (HbA1c)(Baseline, 6 weeks)
- 2-hour postprandial blood glucose (2hPG)(Baseline, 6 weeks)