NDS and NSS for Screening Diabetic Neuropathy

NCT07557641 | Completed

• 2 other identifiers: COA No. 0318/2025214605
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetic Peripheral Neuropathic Pain (DPN)

Keywords

Diabetic Peripheral Neuropathy; Diabetic Sensorimotor Polyneuropathy; Neuropathy Disability Score; Neuropathy Symptom Score; Diabetes Mellitus; Diagnostic Accuracy; Screening; Nerve Conduction Study; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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).

  Single visit (cross-sectional assessment)

Secondary Outcomes (2)

• Prevalence of Diabetic Peripheral Neuropathy

  Single visit

• Clinical Factors Associated With Neuropathy

  Single visit

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulaneuroscience Center, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society

Bangkok, 10330, Thailand

Location

Related Publications (5)

• 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.

  PMID: 20357373 BACKGROUND

• Young 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.

  PMID: 8458529 BACKGROUND

• Dyck 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.

  PMID: 8469345 BACKGROUND

• Shewasinad 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.

  PMID: 33481962 BACKGROUND

• Pop-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.

  PMID: 27999003 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Jakkrit Amornvit, MD

  King Chulalongkorn Memorial Hospital

  STUDY DIRECTOR

• Tharadon Deepracha, MSc

  Chulaneuroscience Center, King Chulalongkorn Memorial hospital, The Thai Red Cross Society

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: March 14, 2024
• Primary Completion: March 13, 2026
• Study Completion: March 13, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De-identified individual participant data and supporting documents will be available beginning 6 months after publication of the primary results and ending 5 years after publication.
• Access Criteria: Access to de-identified individual participant data and supporting documents will be provided to qualified researchers who submit a methodologically sound proposal for analyses consistent with the study objectives and approved by the principal investigator and relevant institutional and ethics requirements. The materials available will include the de-identified participant-level dataset underlying the published results, together with the study protocol, statistical analysis plan, and data dictionary, where applicable. Requests should be submitted in writing to the principal investigator, and access will be granted after review and execution of a data use agreement through a secure data-sharing mechanism.

Locations

TH (1)