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

NCT06074913 | Unknown DMC

• 1 other identifier: GZY-ZJ-KJ-23021-02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Diabetic Peripheral Neuropathy; Diabetes; Electroacupuncture

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline, 6 weeks

• 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.

  Baseline, 6 weeks

• 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.

  Baseline, 6 weeks

• 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.

  Baseline, 6 weeks

Secondary Outcomes (8)

• Electromyogram examination-Sensory conduction velocity of superficial peroneal nerve

  Baseline, 6 weeks

• Electromyogram examination-Sensory conduction velocity of sural nerve

  Baseline, 6 weeks

• Electromyogram examination-Motor conduction velocity of Peroneal nerve

  Baseline, 6 weeks

• Electromyogram examination-Motor conduction velocity of tibial nerve

  Baseline, 6 weeks

• Toronto clinical scoring system

  Baseline, 6 weeks

Study Arms (5)

Healthy group

OTHER

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)

Diabetic group

OTHER

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)

Diabetic peripheral neuropathy group

OTHER

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)

EA group

EXPERIMENTAL

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

Waiting list group

OTHER

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

Other: Basal therapy

Interventions

infrared thermography (IRT) OTHER

Temperatures and infrared thermograms were recorded in the region of the extremities of three groups of subjects by using an infrared thermographic camera.

Diabetic group; Diabetic peripheral neuropathy group; Healthy group

Basal therapy+EA PROCEDURE

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.

EA group

Basal therapy OTHER

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.

Waiting list group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.
• ≤ 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.
• 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;

You may not qualify if:

• 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.
• 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.
• 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;

Sponsors & Collaborators

• Zhejiang Chinese Medical University: lead

Study Sites (1)

the Third affiliated hospital of Zhejiang Chinese Medical university

Hanzhou, Zhejiang, China

RECRUITING

Related Publications (9)

• Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.

  PMID: 31518657 BACKGROUND

• Li Y, Teng D, Shi X, Qin G, Qin Y, Quan H, Shi B, Sun H, Ba J, Chen B, Du J, He L, Lai X, Li Y, Chi H, Liao E, Liu C, Liu L, Tang X, Tong N, Wang G, Zhang JA, Wang Y, Xue Y, Yan L, Yang J, Yang L, Yao Y, Ye Z, Zhang Q, Zhang L, Zhu J, Zhu M, Ning G, Mu Y, Zhao J, Teng W, Shan Z. Prevalence of diabetes recorded in mainland China using 2018 diagnostic criteria from the American Diabetes Association: national cross sectional study. BMJ. 2020 Apr 28;369:m997. doi: 10.1136/bmj.m997.

  PMID: 32345662 BACKGROUND

• Iqbal Z, Azmi S, Yadav R, Ferdousi M, Kumar M, Cuthbertson DJ, Lim J, Malik RA, Alam U. Diabetic Peripheral Neuropathy: Epidemiology, Diagnosis, and Pharmacotherapy. Clin Ther. 2018 Jun;40(6):828-849. doi: 10.1016/j.clinthera.2018.04.001. Epub 2018 Apr 30.

  PMID: 29709457 BACKGROUND

• Bagavathiappan S, Saravanan T, Philip J, Jayakumar T, Raj B, Karunanithi R, Panicker TM, Korath MP, Jagadeesan K. Infrared thermal imaging for detection of peripheral vascular disorders. J Med Phys. 2009 Jan;34(1):43-7. doi: 10.4103/0971-6203.48720.

  PMID: 20126565 BACKGROUND

• Lahiri BB, Bagavathiappan S, Jayakumar T, Philip J. Medical applications of infrared thermography: A review. Infrared Phys Technol. 2012 Jul;55(4):221-235. doi: 10.1016/j.infrared.2012.03.007. Epub 2012 Apr 13.

  PMID: 32288544 BACKGROUND

• Zhou Q, Qian Z, Wu J, Liu J, Ren L, Ren L. Early diagnosis of diabetic peripheral neuropathy based on infrared thermal imaging technology. Diabetes Metab Res Rev. 2021 Oct;37(7):e3429. doi: 10.1002/dmrr.3429. Epub 2021 Feb 4.

  PMID: 33307598 BACKGROUND

• Selvarajah D, Kar D, Khunti K, Davies MJ, Scott AR, Walker J, Tesfaye S. Diabetic peripheral neuropathy: advances in diagnosis and strategies for screening and early intervention. Lancet Diabetes Endocrinol. 2019 Dec;7(12):938-948. doi: 10.1016/S2213-8587(19)30081-6. Epub 2019 Oct 14.

  PMID: 31624024 BACKGROUND

• Yu B, Li M, Huang H, Ma S, Huang K, Zhong Z, Yu S, Zhang L. Acupuncture treatment of diabetic peripheral neuropathy: An overview of systematic reviews. J Clin Pharm Ther. 2021 Jun;46(3):585-598. doi: 10.1111/jcpt.13351. Epub 2021 Jan 28.

  PMID: 33511675 BACKGROUND

• Zhang R, Lao L, Ren K, Berman BM. Mechanisms of acupuncture-electroacupuncture on persistent pain. Anesthesiology. 2014 Feb;120(2):482-503. doi: 10.1097/ALN.0000000000000101.

  PMID: 24322588 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jianqiao Fang

  The Third Clinical Medical College of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianqiao Fang

CONTACT

+8613606707532; fangjianqiao7532@163.com

Jing Sun

CONTACT

+8613429610268; sunjing0268@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 10, 2023
• Study Start: July 7, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

CN (1)