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Thai PainPREDICT Validation Study

NCT07195045 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2025-10-03

No results posted yet for this study

Summary

Painful diabetic neuropathy (PDN) is one of the most common and disabling complications of diabetes mellitus, substantially affecting quality of life, daily functioning, and health system burden. Early identification of PDN is crucial for timely treatment, prevention of complications such as foot ulcers and amputations, and for reducing healthcare costs. However, in Thailand there are limited culturally adapted and validated tools for screening PDN. PainPREDICT is an internationally validated questionnaire designed to characterize neuropathic pain profiles, but its adaptation for Thai patients has not yet been undertaken. In parallel, the use of mobile health technologies (mHealth) has the potential to expand access to screening and monitoring of chronic conditions, particularly in resource-limited settings.

Conditions

  • Painful Diabetic Neuropathy (PDN)
  • Diabetic Neuropathy, Distal Symmetric Polyneuropathy (Manifestation)
  • Type 1 Diabetes Mellitus (T1DM)
  • Type 2 Diabetes Mellitus (T2DM)
  • Neuropathic Pain
  • Diabetes Complications

Interventions

DIAGNOSTIC_TEST

Thai PainPREDICT Questionnaire and Mobile Application

The Thai PainPREDICT Questionnaire is a culturally adapted and validated version of an internationally recognized neuropathic pain assessment tool. In this study, it is administered via both paper form and a secure mobile application designed for Thai patients with diabetes. The app automates scoring, provides real-time feedback, and securely stores data in REDCap in compliance with Thai Personal Data Protection Act (PDPA). The intervention is used to screen for painful diabetic neuropathy and compare results against clinical diagnosis and neurophysiological testing, including DN4, nerve conduction studies, and quantitative sensory testing.

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Jakkrit Amornvit, MD · King Chulalongkorn Memorial Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-28
Primary Completion
2027-08-27
Completion
2027-12-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07195045 on ClinicalTrials.gov