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

Primary Purpose

Diabetic Peripheral Neuropathy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
infrared thermography (IRT)
Basal therapy+EA
Basal therapy
Sponsored by
Zhejiang Chinese Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Peripheral Neuropathy focused on measuring Diabetic Peripheral Neuropathy, Diabetes, Electroacupuncture

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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: Inclusion Criteria: 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 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; 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: 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.

Sites / Locations

  • the Third affiliated hospital of Zhejiang Chinese Medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Experimental

Other

Arm Label

Healthy group

Diabetic group

Diabetic peripheral neuropathy group

EA group

Waiting list group

Arm Description

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.

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.

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.

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.

The subjects in this group will receive only basal treatment with no additional therapies during the study period.

Outcomes

Primary Outcome Measures

Temperature of the soles of the feet
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
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 palm
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
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 Outcome Measures

Electromyogram examination-Sensory conduction velocity of superficial peroneal nerve
Participants in part 1 (except Health Volunteers)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.
Electromyogram examination-Sensory conduction velocity of sural nerve
Participants in part 1 (except Health Volunteers)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.
Electromyogram examination-Motor conduction velocity of Peroneal nerve
Participants in part 1 (except Health Volunteers)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.
Electromyogram examination-Motor conduction velocity of tibial nerve
Participants in part 1 (except Health Volunteers)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.
Toronto clinical scoring system
Participants in part 1 (except Health Volunteers)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. The scale is an assessment of foot sensation and has a total score of 19, divided into three sections: symptom score of 6, reflex score of 8 and sensory score of 5. Symptom score: 0 = absent, 1 = present; reflex score: 0 = normal, 1 = diminished, 2 = absent; sensory score: 0 = normal, 1 = abnormal.
Glycated haemoglobin (HbA1c)
Participants in part 1 (except Health Volunteers)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.
Fasting blood glucose (FPG)
Participants in part 1 (except Health Volunteers)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.
2-hour postprandial blood glucose (2hPG)
Participants in part 1 (except Health Volunteers)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.

Full Information

First Posted
September 21, 2023
Last Updated
October 5, 2023
Sponsor
Zhejiang Chinese Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06074913
Brief Title
Early Warning of Diabetic Peripheral Neuropathy by Using Infrared Thermography and the Effectiveness of Electroacupuncture in Its Prevention
Official Title
Early Warning of Diabetic Peripheral Neuropathy by Using Infrared Thermography and the Effectiveness of Electroacupuncture in Its Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy
Keywords
Diabetic Peripheral Neuropathy, Diabetes, Electroacupuncture

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy group
Arm Type
Other
Arm Description
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.
Arm Title
Diabetic group
Arm Type
Other
Arm Description
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.
Arm Title
Diabetic peripheral neuropathy group
Arm Type
Other
Arm Description
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.
Arm Title
EA group
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting list group
Arm Type
Other
Arm Description
The subjects in this group will receive only basal treatment with no additional therapies during the study period.
Intervention Type
Other
Intervention Name(s)
infrared thermography (IRT)
Intervention Description
Temperatures and infrared thermograms were recorded in the region of the extremities of three groups of subjects by using an infrared thermographic camera.
Intervention Type
Procedure
Intervention Name(s)
Basal therapy+EA
Intervention Description
After specialist treatment, blood glucose is managed through hypoglycemic medications or insulin. Patients with both hypertension and hyperlipidemia are prescribed antihypertensive and lipid-lowering drugs. Additional medications are determined based on the patient's current medication regimen. 2. Acupoints: Qihai (RN6), Guanyuan (RN4), Xuehai (SP10), Yanglingquan (GB34), Zusanli (T36), Yinlingquan (SP9), Sanyinjiao (SP6), Xuanzhong (GB39), Jiexi (ST41), Zulinqi (GB41), Taichong (SP41). The electrode will be connected Yanglingquan (GB34) and Sanyinjiao (SP6), electrode wire will be connected to the electro-acupuncture apparatus using continuous wave with a frequency of 2Hz at an intensity suitable for the comfort of the subject.
Intervention Type
Other
Intervention Name(s)
Basal therapy
Intervention Description
After specialist treatment, blood glucose is managed through hypoglycemic medications or insulin. Patients with both hypertension and hyperlipidemia are prescribed antihypertensive and lipid-lowering drugs. Additional medications are determined based on the patient's current medication regimen.
Primary Outcome Measure Information:
Title
Temperature of the soles of the feet
Description
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.
Time Frame
Baseline, 6 weeks
Title
Temperature of the instep
Description
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.
Time Frame
Baseline, 6 weeks
Title
Temperature of the palm
Description
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.
Time Frame
Baseline, 6 weeks
Title
Temperature of the back of the hand
Description
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.
Time Frame
Baseline, 6 weeks
Secondary Outcome Measure Information:
Title
Electromyogram examination-Sensory conduction velocity of superficial peroneal nerve
Description
Participants in part 1 (except Health Volunteers)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.
Time Frame
Baseline, 6 weeks
Title
Electromyogram examination-Sensory conduction velocity of sural nerve
Description
Participants in part 1 (except Health Volunteers)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.
Time Frame
Baseline, 6 weeks
Title
Electromyogram examination-Motor conduction velocity of Peroneal nerve
Description
Participants in part 1 (except Health Volunteers)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.
Time Frame
Baseline, 6 weeks
Title
Electromyogram examination-Motor conduction velocity of tibial nerve
Description
Participants in part 1 (except Health Volunteers)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.
Time Frame
Baseline, 6 weeks
Title
Toronto clinical scoring system
Description
Participants in part 1 (except Health Volunteers)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. The scale is an assessment of foot sensation and has a total score of 19, divided into three sections: symptom score of 6, reflex score of 8 and sensory score of 5. Symptom score: 0 = absent, 1 = present; reflex score: 0 = normal, 1 = diminished, 2 = absent; sensory score: 0 = normal, 1 = abnormal.
Time Frame
Baseline, 6 weeks
Title
Glycated haemoglobin (HbA1c)
Description
Participants in part 1 (except Health Volunteers)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.
Time Frame
Baseline, 6 weeks
Title
Fasting blood glucose (FPG)
Description
Participants in part 1 (except Health Volunteers)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.
Time Frame
Baseline, 6 weeks
Title
2-hour postprandial blood glucose (2hPG)
Description
Participants in part 1 (except Health Volunteers)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.
Time Frame
Baseline, 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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: Inclusion Criteria: 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 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; 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianqiao Fang
Phone
+8613606707532
Email
fangjianqiao7532@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Sun
Phone
+8613429610268
Email
sunjing0268@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianqiao Fang
Organizational Affiliation
The Third Clinical Medical College of Zhejiang Chinese Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Third affiliated hospital of Zhejiang Chinese Medical university
City
Hanzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Luo
Email
921941696@qq.com

12. IPD Sharing Statement

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

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