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

Diabetic Peripheral Neuropathy Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

• NCT number: NCT06074913
• Study type: Interventional
• Source: Zhejiang Chinese Medical University
• Contact: Jianqiao Fang
• Phone: +8613606707532
• Email: fangjianqiao7532@163.com
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2023
• Completion date: December 2025