CompletedNot Applicable

NDS and NSS for Screening Diabetic Neuropathy

Thailand228 participantsStarted 2024-03-14

Plain-language 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.

Who can participate

Age range

30 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diagnostic Accuracy of NDS and NSS for Diabetic Neuropathy

Timeframe: Single visit (cross-sectional assessment)

Trial details

NCT IDNCT07557641

SponsorChulalongkorn University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-03-13

View on ClinicalTrials.gov More Diabetic Peripheral Neuropathic Pain (DPN) trials