Diabetic Peripheral NeuropathyNCT06074913
Early Warning of Diabetic Peripheral Neuropathy by Using Infrared Thermography and the Effectiveness of Electroacupuncture in Its Prevention
A study testing infrared thermography (IRT), Basal therapy+EA and Basal therapy in people with Diabetic Peripheral Neuropathy, run by Zhejiang Chinese Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- infrared thermography (IRT), Basal therapy+EA and Basal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
- Persons with severe mental illness, depression, alcohol dependence, or a history of substance abuse;
Show all 18Show fewer
- 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;
- Part Ⅱ：
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Third affiliated hospital of Zhejiang Chinese Medical university
Hanzhou, Zhejiang
Ning Luo, 921941696@qq.com
About this study
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.
Read the 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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- infrared thermography (IRT), Basal therapy+EA, Basal therapy
- Keywords
- Diabetic Peripheral Neuropathy, Diabetes, Electroacupuncture
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Basal therapy+EAProcedure or surgery
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.
Basal therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Basal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 weeks
Secondary outcomes (8)
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.
Measured: Baseline, 6 weeks
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.
Measured: Baseline, 6 weeks
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.
Measured: Baseline, 6 weeks
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.
Measured: Baseline, 6 weeks
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.
Measured: Baseline, 6 weeks
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.
Measured: Baseline, 6 weeks
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.
Measured: Baseline, 6 weeks
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.
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start7 Jul 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Chinese Medical University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jianqiao Fang, Zhejiang Chinese Medical University
- Investigators
- Jianqiao Fang, Principal investigator, The Third Clinical Medical College of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074913
- Sponsor's protocol ID
- GZY-ZJ-KJ-23021-02
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31518657Li 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.
PubMed 32345662Iqbal 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.
PubMed 29709457Bagavathiappan 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.
PubMed 20126565Lahiri 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.
PubMed 32288544Zhou 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.
PubMed 33307598Selvarajah 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.
PubMed 31624024Yu 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.
PubMed 33511675Zhang 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.
PubMed 24322588
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Warning of Diabetic Peripheral Neuropathy by Using Infrared Thermography and the Effectiveness of Electroacupuncture in Its Prevention
- ClinicalTrials.gov ID
- NCT06074913
- Acronym / sponsor ID
- GZY-ZJ-KJ-23021-02
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Diabetic Peripheral Neuropathy, Diabetes, Electroacupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhejiang Chinese Medical UniversityOther government
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy group | Other | Other: infrared thermography (IRT)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. |
| Diabetic group | Other | Other: infrared thermography (IRT)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. |
| Diabetic peripheral neuropathy group | Other | Other: infrared thermography (IRT)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. |
| EA group | Experimental | Procedure: Basal therapy+EASubjects 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. |
| Waiting list group | Other | Other: Basal therapyThe subjects in this group will receive only basal treatment with no additional therapies during the study period. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (18 listed)
- Part Ⅰ： Exclusion criteria for healthy subjects
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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, Diabetic peripheral neuropathy group, Healthy group |
| Basal therapy+EAAfter 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. | Procedure or surgery | EA group |
| Basal therapyAfter 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. | Other | Waiting list group |
Primary outcome
Temperature of the soles of the feet
Time frame: 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.
Temperature of the instep
Time frame: 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.
Temperature of the palm
Time frame: 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.
Temperature of the back of the hand
Time frame: 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.
8 secondary outcomes
Electromyogram examination-Sensory conduction velocity of superficial peroneal nerve
Time frame: Baseline, 6 weeks
Electromyogram examination-Sensory conduction velocity of sural nerve
Time frame: Baseline, 6 weeks
Electromyogram examination-Motor conduction velocity of Peroneal nerve
Time frame: Baseline, 6 weeks
Electromyogram examination-Motor conduction velocity of tibial nerve
Time frame: Baseline, 6 weeks
Toronto clinical scoring system
Time frame: Baseline, 6 weeks
Glycated haemoglobin (HbA1c)
Time frame: Baseline, 6 weeks
Fasting blood glucose (FPG)
Time frame: Baseline, 6 weeks
2-hour postprandial blood glucose (2hPG)
Time frame: Baseline, 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Background: PubMed 31518657Saeedi 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.
- Background: PubMed 32345662Li 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.
- Background: PubMed 29709457Iqbal 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.
- Background: PubMed 20126565Bagavathiappan 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.
- Background: PubMed 32288544Lahiri 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.
- Background: PubMed 33307598Zhou 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.
- Background: PubMed 31624024Selvarajah 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.
- Background: PubMed 33511675Yu 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.
- Background: PubMed 24322588Zhang 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.
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Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianqiao Fang principal investigator
The Third Clinical Medical College of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infrared thermography (IRT), Basal therapy+EA and Basal therapy in people with Diabetic Peripheral Neuropathy, run by Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianqiao Fang (+8613606707532, fangjianqiao7532@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature of the soles of the feet (time frame: Baseline, 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06074913, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.