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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
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• Part Ⅰ:

⁃ 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.

⁃ 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.

⁃ 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.

Locations
Other Locations
China
the Third affiliated hospital of Zhejiang Chinese Medical university
RECRUITING
Hanzhou
Contact Information
Primary
Jianqiao Fang
fangjianqiao7532@163.com
+8613606707532
Backup
Jing Sun
sunjing0268@163.com
+8613429610268
Time Frame
Start Date: 2023-07-07
Estimated Completion Date: 2025-12
Participants
Target number of participants: 200
Treatments
Other: Healthy group
After the healthy volunteers met the requirements through screening (i.e., demographic data recording,medical history taking, physical examination report review and recording on the day of enrollment), IRT was performed on the extremities, with 1 image automatically taken every 10 s for 1 min, and 6 images for each site.
Other: Diabetic group
After screening to meet the inclusion criteria for this study, IRT was performed on the extremities, with 1 image automatically taken every 10s for 1 min, and 6 images for each site.
Other: Diabetic peripheral neuropathy group
After screening to meet the inclusion criteria for this study, IRT was performed on the extremities, with 1 image automatically taken every 10s for 1 min, and 6 images for each site.
Experimental: EA group
Subjects in this group received electroacupuncture along with the basic treatment at a frequency of 2 treatments per week for 6 weeks for a total of 12 interventions.
Other: Waiting list group
The subjects in this group will receive only basal treatment with no additional therapies during the study period.
Sponsors
Leads: Zhejiang Chinese Medical University

This content was sourced from clinicaltrials.gov