Thai Version of PainPREDICT: Translation, Validation, and Mobile Application Development for Screening Painful Diabetic Neuropathy in Diabetes Patients

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults aged 18 years or older.

• Diagnosed with type 1 diabetes mellitus or type 2 diabetes mellitus.

• Able to communicate in Thai.

• Willing and able to provide written informed consent.

Locations
Other Locations
Thailand
King Chulalongkorn Memorial hospital, The Thai Red Cross Society
RECRUITING
Pathum Wan
Contact Information
Primary
Jakkrit Amornvit, MD
jakkrit.a@chula.ac.th
+66622169338
Backup
Tharadon Deepracha, MSc
tharadon.d@chulahospital.org
+66622169338
Time Frame
Start Date: 2025-08-28
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 277
Treatments
Experimental: Arm 1: Painful Diabetic Neuropathy (PDN) Group
Adults with type 1 or type 2 diabetes who have painful diabetic neuropathy, confirmed by clinical assessment. Participants will complete the Thai PainPREDICT questionnaire via the mobile application and/or paper version. Results will be compared against clinical diagnosis and neurophysiological tests.
Active_comparator: Arm 2: Non-PDN Diabetic Control Group
Adults with type 1 or type 2 diabetes without painful neuropathy, matched by age, sex, and diabetes type. Participants will complete the Thai PainPREDICT questionnaire via the mobile application and/or paper version, with results compared against clinical assessment and neurophysiological testing.
Sponsors
Leads: Chulalongkorn University

This content was sourced from clinicaltrials.gov