Clincosm LogoSign in Get a demo

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

Sponsor
Zhejiang Chinese Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06074913
Collaborator
(none)
200
Enrollment
1
Location
5
Arms
28.8
Anticipated Duration (Months)
6.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: infrared thermography (IRT)
  • Procedure: Basal therapy+EA
  • Other: Basal therapy
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Early Warning of Diabetic Peripheral Neuropathy by Using Infrared Thermography and the Effectiveness of Electroacupuncture in Its Prevention
Actual Study Start Date :
Jul 7, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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: infrared thermography (IRT)
Temperatures and infrared thermograms were recorded in the region of the extremities of three groups of subjects by using an infrared thermographic camera.
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: infrared thermography (IRT)
Temperatures and infrared thermograms were recorded in the region of the extremities of three groups of subjects by using an infrared thermographic camera.
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.

Other: infrared thermography (IRT)
Temperatures and infrared thermograms were recorded in the region of the extremities of three groups of subjects by using an infrared thermographic camera.
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.

Procedure: Basal therapy+EA
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.
Other: Waiting list group

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

Other: Basal therapy
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.

Outcome Measures

Primary Outcome Measures

  1. Temperature of the soles of the feet [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.

  2. Temperature of the instep [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.

  3. Temperature of the palm [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.

  4. Temperature of the back of the hand [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 Outcome Measures

  1. Electromyogram examination-Sensory conduction velocity of superficial peroneal nerve [Baseline, 6 weeks]

    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. Electromyogram examination-Sensory conduction velocity of sural nerve [Baseline, 6 weeks]

    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.

  3. Electromyogram examination-Motor conduction velocity of Peroneal nerve [Baseline, 6 weeks]

    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.

  4. Electromyogram examination-Motor conduction velocity of tibial nerve [Baseline, 6 weeks]

    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.

  5. Toronto clinical scoring system [Baseline, 6 weeks]

    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.

  6. Glycated haemoglobin (HbA1c) [Baseline, 6 weeks]

    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.

  7. Fasting blood glucose (FPG) [Baseline, 6 weeks]

    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.

  8. 2-hour postprandial blood glucose (2hPG) [Baseline, 6 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Part Ⅰ：
Inclusion criteria for healthy subjects:

  1. 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;

  2. 18 years old ≤ age ≤ 85 years old, gender is not limited;

  3. Have normal communication ability;

  4. 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

  1. 18 ≤ age ≤ 85 years old, with any disease duration and any gender;

  2. Lower limb nerve electromyography shows no slowing of conduction velocity;

  3. Normal communication ability;

  4. No serious heart, brain, liver, kidney and other internal diseases, no serious mental illness and cognitive impairment;

  5. 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

  1. 18 years ≤ age ≤ 85 years with any disease duration and any gender;

  2. Clear history of diabetes mellitus;

  3. 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;

  4. TCSS score of 6-8;

  5. Have normal communication skills;

  6. No serious heart, brain, liver, kidney and other medical disorders, no serious mental illness and cognitive impairment;

  7. 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:

  1. 18 years ≤ age ≤ 85 years with any disease duration and any gender;

  2. 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

  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. Volunteers who are participating in other interventional clinical trials;

  4. 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

  1. Persons 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, peripheral neuropathy, lactic acidosis, and severe infections;

  4. Volunteers who are participating in other interventional clinical trials;

  5. 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

  1. TCSS score > 8;

  2. 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;

  3. Women who are in preparation for pregnancy, during pregnancy, or breastfeeding;

  4. Those with acute complications such as combined lactic acidosis and severe infections;

  5. Those who suffer from serious liver or kidney damage or serious cardiovascular diseases and cannot take care of themselves;

  6. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 the Third affiliated hospital of Zhejiang Chinese Medical university Hanzhou Zhejiang China

Sponsors and Collaborators

  • Zhejiang Chinese Medical University

Investigators

  • Principal Investigator: Jianqiao Fang, The Third Clinical Medical College of Zhejiang Chinese Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jianqiao Fang, professor, Zhejiang Chinese Medical University
ClinicalTrials.gov Identifier:
NCT06074913
Other Study ID Numbers:
  • GZY-ZJ-KJ-23021-02
First Posted:
Oct 10, 2023
Last Update Posted:
Oct 10, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jianqiao Fang, professor, Zhejiang Chinese Medical University
Diabetic Peripheral Neuropathy
Diabetes
Electroacupuncture
Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies

Study Results

No Results Posted as of Oct 10, 2023