Diabetic Peripheral Neuropathic Pain (DPN)NCT07557641
NDS and NSS for Screening Diabetic Neuropathy
An observational study of Diabetic Peripheral Neuropathic Pain (DPN), run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Diabetic sensorimotor polyneuropathy is a common complication of diabetes mellitus that can lead to pain, sensory loss, foot ulcers, and disability. Early detection is important, but standard diagnostic tests such as nerve conduction studies are not always easily accessible in routine clinical practice. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain (DPN)
- How many people
- 228 participants
- Where
- 1 siteThailand
- Study dates
- 14 Mar 2024to 13 Mar 2026
- Phase
- Observational
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with diabetes mellitus (type 1 and type 2) receiving care at King Chulalongkorn Memorial Hospital, Bangkok, Thailand. Participants will be recruited from neurology and endocrinology clinics and are representative of patients undergoing evaluation for diabetic peripheral neuropathy in a tertiary care setting.
Who may be able to join
- Adults aged 30 to 65 years
- Diagnosed with diabetes mellitus (type 1 or type 2) by a physician
- Able and willing to provide informed consent
- Willing to undergo clinical evaluation and neurophysiological testing, including nerve conduction studies
Who cannot join
- History of other causes of peripheral neuropathy (e.g., nutritional deficiency, alcohol-related neuropathy, chronic kidney disease)
- Known neuromuscular or neurological disorders (e.g., myopathy, hereditary neuropathy, Guillain-Barré syndrome, chronic inflammatory neuropathy)
- Exposure to neurotoxic agents (e.g., drugs, heavy metals)
- Presence of lower limb conditions interfering with assessment (e.g., amputation, chronic wounds, significant edema)
- Inability to communicate or complete study procedures
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Chulaneuroscience Center, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society
Bangkok, 10330
About this study
Official title: Utilizing the Neuropathy Disability Score and Neuropathy Symptom Score for Screening Diabetic Sensorimotor Polyneuropathy
Diabetic sensorimotor polyneuropathy is a common complication of diabetes mellitus that can lead to pain, sensory loss, foot ulcers, and disability. Early detection is important, but standard diagnostic tests such as nerve conduction studies are not always easily accessible in routine clinical practice.
This study aims to evaluate the accuracy and reliability of two simple clinical tools, the Neuropathy Disability Score (NDS) and the Neuropathy Symptom Score (NSS), for screening diabetic peripheral neuropathy. These tools are based on patient-reported symptoms and bedside neurological examination and may provide a practical alternative for early detection.
Read more
In this cross-sectional diagnostic accuracy study, adult patients with diabetes will be recruited from King Chulalongkorn Memorial Hospital. Participants will undergo clinical assessments, questionnaires, laboratory investigations, and neurophysiological testing, including nerve conduction studies, which will serve as the reference standard. The performance of NDS and NSS will be analyzed to determine their sensitivity, specificity, and overall diagnostic value.
The results of this study may support the use of simple, accessible screening tools for early identification of diabetic neuropathy, potentially improving patient care and reducing complications.
Read the detailed description
This study is an analytic cross-sectional diagnostic accuracy study designed to evaluate the performance of the Neuropathy Disability Score (NDS) and Neuropathy Symptom Score (NSS) in screening for diabetic sensorimotor polyneuropathy.
Adult patients with diabetes mellitus (type 1 and type 2) will be recruited from King Chulalongkorn Memorial Hospital. Eligible participants will undergo a standardized assessment protocol, including demographic and clinical data collection, physical examination, and laboratory investigations. Patient-reported outcomes will be assessed using validated questionnaires, including the Neuropathy Symptom Score (NSS), Neuropathy Disability Score (NDS), DN4 questionnaire, Michigan Neuropathy Screening Instrument (MNSI), and other relevant clinical tools.
All participants will undergo nerve conduction studies (NCS), which will serve as the reference standard for the diagnosis of diabetic peripheral neuropathy. Additional assessments may include quantitative sensory testing (QST), monofilament testing, hand grip strength measurement, ankle-brachial index (ABI), and body composition analysis, depending on clinical indication.
The primary objective is to determine the diagnostic accuracy of NDS and NSS compared with the reference standard, including sensitivity, specificity, and optimal cutoff values. Secondary objectives include evaluating the prevalence of neuropathy among patients with diabetes, identifying associated risk factors, and comparing clinical characteristics between type 1 and type 2 diabetes.
Statistical analysis will include descriptive statistics, group comparisons using appropriate parametric or non-parametric tests, and receiver operating characteristic (ROC) curve analysis to determine diagnostic performance. Correlation analyses will also be performed to assess associations between clinical variables and neuropathy outcomes.
The findings from this study are expected to support the use of simple, cost-effective screening tools for early detection of diabetic peripheral neuropathy in clinical practice, particularly in resource-limited settings.
- Keywords
- Diabetic Peripheral Neuropathy, Diabetic Sensorimotor Polyneuropathy, Neuropathy Disability Score, Neuropathy Symptom Score, Diabetes Mellitus, Diagnostic Accuracy, Screening, Nerve Conduction Study, Peripheral Neuropathy
- Medical subject headings
- Diabetes Mellitus, Peripheral Nervous System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of NDS and NSS for Diabetic Neuropathy
To evaluate the diagnostic performance of the Neuropathy Disability Score (NDS) and Neuropathy Symptom Score (NSS) compared with nerve conduction studies (NCS) as the reference standard, including sensitivity, specificity, and area under the ROC curve (AUC).
Measured: Single visit (cross-sectional assessment)
Secondary outcomes (2)
Prevalence of Diabetic Peripheral Neuropathy
To determine the prevalence of diabetic peripheral neuropathy based on nerve conduction study results.
Measured: Single visit
Clinical Factors Associated With Neuropathy
To assess associations between clinical variables (e.g., duration of diabetes, glycemic control) and neuropathy.
Measured: Single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start14 Mar 2024
- Primary completion13 Mar 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral Neuropathic Pain (DPN)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakkrit Amornvit, MD, Study director, King Chulalongkorn Memorial HospitalTharadon Deepracha, MSc, Principal investigator, Chulaneuroscience Center, King Chulalongkorn Memorial hospital, The Thai Red Cross Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557641
- Sponsor's protocol ID
- COA No. 0318/2025
- Other IDs
- 214605
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared with qualified researchers upon reasonable request, subject to approval by the principal investigator, institutional review board/ethics committee requirements, and a data use agreement to protect participant confidentiality.
Publications
Perkins BA, Orszag A, Ngo M, Ng E, New P, Bril V. Prediction of incident diabetic neuropathy using the monofilament examination: a 4-year prospective study. Diabetes Care. 2010 Jul;33(7):1549-54. doi: 10.2337/dc09-1835. Epub 2010 Mar 31.
PubMed 20357373Young MJ, Boulton AJ, MacLeod AF, Williams DR, Sonksen PH. A multicentre study of the prevalence of diabetic peripheral neuropathy in the United Kingdom hospital clinic population. Diabetologia. 1993 Feb;36(2):150-4. doi: 10.1007/BF00400697.
PubMed 8458529Dyck PJ, Kratz KM, Karnes JL, Litchy WJ, Klein R, Pach JM, Wilson DM, O'Brien PC, Melton LJ 3rd, Service FJ. The prevalence by staged severity of various types of diabetic neuropathy, retinopathy, and nephropathy in a population-based cohort: the Rochester Diabetic Neuropathy Study. Neurology. 1993 Apr;43(4):817-24. doi: 10.1212/wnl.43.4.817.
PubMed 8469345Shewasinad Yehualashet S, Asefa KK, Mekonnen AG, Gemeda BN, Shiferaw WS, Aynalem YA, Bilchut AH, Derseh BT, Mekuria AD, Mekonnen WN, Meseret WA, Tegegnework SS, Abosetegn AE. Predictors of adherence to COVID-19 prevention measure among communities in North Shoa Zone, Ethiopia based on health belief model: A cross-sectional study. PLoS One. 2021 Jan 22;16(1):e0246006. doi: 10.1371/journal.pone.0246006. eCollection 2021.
PubMed 33481962Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.
PubMed 27999003
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing the Neuropathy Disability Score and Neuropathy Symptom Score for Screening Diabetic Sensorimotor Polyneuropathy
- ClinicalTrials.gov ID
- NCT07557641
- Acronym / sponsor ID
- COA No. 0318/2025
- Keywords
- Diabetic Peripheral Neuropathy, Diabetic Sensorimotor Polyneuropathy, Neuropathy Disability Score, Neuropathy Symptom Score, Diabetes Mellitus, Diagnostic Accuracy, Screening, Nerve Conduction Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 29 Apr 2026 (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.
Diabetic sensorimotor polyneuropathy is a common complication of diabetes mellitus that can lead to pain, sensory loss, foot ulcers, and disability. Early detection is important, but standard diagnostic tests such as nerve conduction studies are not always easily accessible in routine clinical practice.
This study aims to evaluate the accuracy and reliability of two simple clinical tools, the Neuropathy Disability Score (NDS) and the Neuropathy Symptom Score (NSS), for screening diabetic peripheral neuropathy. These tools are based on patient-reported symptoms and bedside neurological examination and may provide a practical alternative for early detection.
In this cross-sectional diagnostic accuracy study, adult patients with diabetes will be recruited from King Chulalongkorn Memorial Hospital. Participants will undergo clinical assessments, questionnaires, laboratory investigations, and neurophysiological testing, including nerve conduction studies, which will serve as the reference standard. The performance of NDS and NSS will be analyzed to determine their sensitivity, specificity, and overall diagnostic value.
The results of this study may support the use of simple, accessible screening tools for early identification of diabetic neuropathy, potentially improving patient care and reducing complications.
Detailed description
This study is an analytic cross-sectional diagnostic accuracy study designed to evaluate the performance of the Neuropathy Disability Score (NDS) and Neuropathy Symptom Score (NSS) in screening for diabetic sensorimotor polyneuropathy.
Adult patients with diabetes mellitus (type 1 and type 2) will be recruited from King Chulalongkorn Memorial Hospital. Eligible participants will undergo a standardized assessment protocol, including demographic and clinical data collection, physical examination, and laboratory investigations. Patient-reported outcomes will be assessed using validated questionnaires, including the Neuropathy Symptom Score (NSS), Neuropathy Disability Score (NDS), DN4 questionnaire, Michigan Neuropathy Screening Instrument (MNSI), and other relevant clinical tools.
All participants will undergo nerve conduction studies (NCS), which will serve as the reference standard for the diagnosis of diabetic peripheral neuropathy. Additional assessments may include quantitative sensory testing (QST), monofilament testing, hand grip strength measurement, ankle-brachial index (ABI), and body composition analysis, depending on clinical indication.
The primary objective is to determine the diagnostic accuracy of NDS and NSS compared with the reference standard, including sensitivity, specificity, and optimal cutoff values. Secondary objectives include evaluating the prevalence of neuropathy among patients with diabetes, identifying associated risk factors, and comparing clinical characteristics between type 1 and type 2 diabetes.
Statistical analysis will include descriptive statistics, group comparisons using appropriate parametric or non-parametric tests, and receiver operating characteristic (ROC) curve analysis to determine diagnostic performance. Correlation analyses will also be performed to assess associations between clinical variables and neuropathy outcomes.
The findings from this study are expected to support the use of simple, cost-effective screening tools for early detection of diabetic peripheral neuropathy in clinical practice, particularly in resource-limited settings.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with diabetes mellitus (type 1 and type 2) receiving care at King Chulalongkorn Memorial Hospital, Bangkok, Thailand. Participants will be recruited from neurology and endocrinology clinics and are representative of patients undergoing evaluation for diabetic peripheral neuropathy in a tertiary care setting.
Key inclusion criteria (4 listed)
- Adults aged 30 to 65 years
- Diagnosed with diabetes mellitus (type 1 or type 2) by a physician
- Able and willing to provide informed consent
- Willing to undergo clinical evaluation and neurophysiological testing, including nerve conduction studies
Key exclusion criteria (5 listed)
- History of other causes of peripheral neuropathy (e.g., nutritional deficiency, alcohol-related neuropathy, chronic kidney disease)
- Known neuromuscular or neurological disorders (e.g., myopathy, hereditary neuropathy, Guillain-Barré syndrome, chronic inflammatory neuropathy)
- Exposure to neurotoxic agents (e.g., drugs, heavy metals)
- Presence of lower limb conditions interfering with assessment (e.g., amputation, chronic wounds, significant edema)
- Inability to communicate or complete study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of NDS and NSS for Diabetic Neuropathy
Time frame: Single visit (cross-sectional assessment)
To evaluate the diagnostic performance of the Neuropathy Disability Score (NDS) and Neuropathy Symptom Score (NSS) compared with nerve conduction studies (NCS) as the reference standard, including sensitivity, specificity, and area under the ROC curve (AUC).
2 secondary outcomes
Prevalence of Diabetic Peripheral Neuropathy
Time frame: Single visit
Clinical Factors Associated With Neuropathy
Time frame: Single visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 20357373Perkins BA, Orszag A, Ngo M, Ng E, New P, Bril V. Prediction of incident diabetic neuropathy using the monofilament examination: a 4-year prospective study. Diabetes Care. 2010 Jul;33(7):1549-54. doi: 10.2337/dc09-1835. Epub 2010 Mar 31.
- Background: PubMed 8458529Young MJ, Boulton AJ, MacLeod AF, Williams DR, Sonksen PH. A multicentre study of the prevalence of diabetic peripheral neuropathy in the United Kingdom hospital clinic population. Diabetologia. 1993 Feb;36(2):150-4. doi: 10.1007/BF00400697.
- Background: PubMed 8469345Dyck PJ, Kratz KM, Karnes JL, Litchy WJ, Klein R, Pach JM, Wilson DM, O'Brien PC, Melton LJ 3rd, Service FJ. The prevalence by staged severity of various types of diabetic neuropathy, retinopathy, and nephropathy in a population-based cohort: the Rochester Diabetic Neuropathy Study. Neurology. 1993 Apr;43(4):817-24. doi: 10.1212/wnl.43.4.817.
- Background: PubMed 33481962Shewasinad Yehualashet S, Asefa KK, Mekonnen AG, Gemeda BN, Shiferaw WS, Aynalem YA, Bilchut AH, Derseh BT, Mekuria AD, Mekonnen WN, Meseret WA, Tegegnework SS, Abosetegn AE. Predictors of adherence to COVID-19 prevention measure among communities in North Shoa Zone, Ethiopia based on health belief model: A cross-sectional study. PLoS One. 2021 Jan 22;16(1):e0246006. doi: 10.1371/journal.pone.0246006. eCollection 2021.
- Background: PubMed 27999003Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared with qualified researchers upon reasonable request, subject to approval by the principal investigator, institutional review board/ethics committee requirements, and a data use agreement to protect participant confidentiality.
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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.
Jakkrit Amornvit, MD study director
King Chulalongkorn Memorial Hospital
Tharadon Deepracha, MSc principal investigator
Chulaneuroscience Center, King Chulalongkorn Memorial hospital, The Thai Red Cross Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Peripheral Neuropathic Pain (DPN), run by Chulalongkorn University at 1 site in Thailand.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 29 Apr 2026. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of NDS and NSS for Diabetic Neuropathy (time frame: Single visit (cross-sectional assessment)). 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 NCT07557641, which also lists 5 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 29 Apr 2026.