Thai PainPREDICT Validation Study

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.

NCT Number	NCT07195045
Lead Sponsor	Chulalongkorn University
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
Enrollment	277 participants
Start Date	2025-08-28
Primary Completion	2027-08-27 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-10-03