Thermo-Tactile Feedback Patch for Preventing Thermal Injury in Patients with Diabetic Peripheral Neuropathy

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Group 1:Phase A (Sham): The thermo‐tactile feedback patch is applied without electrical activation. This is followed by a 10? to 15?minute washout period. Phase B (Active): The patch is applied and activated (providing thermo‐tactile feedback).;Group 2:Phase B (Active): The patch is applied and powered on to provide thermo‐tactile feedback. This is followed by a 10? to 15?minute washout period. Phase A (Sham): The thermo‐tactile feedback patch is applied without electrical activation.; CONDITION: Diabetic Peripheral Neuropathy (DPN) with impaired thermal sensation PRIMARY OUTCOME: Hazard Avoidance Accuracy; SECONDARY OUTCOME: Subjective Experience Score;Reaction Time;Incidence of Adverse Events;Heat Source Localization and Trajectory Recognition Accuracy;Temperature Gradient Recognition Accuracy; INCLUSION CRITERIA: 1. Aged 18‐75 years, male or female; 1. Diagnosed with type 2 diabetes mellitus (T2DM) for >=1 year. 2. Met the diagnostic criteria for diabetic peripheral neuropathy (DPN) (Neuropathy Disability Score [NDS] =3 or Michigan Neuropathy Screening Instrument [MNSI] positive) and had clinically confirmed impaired thermal sensation. 3. Able to understand the study procedures, voluntarily participate in the study, and provide written informed consent.
Epistemonikos ID: 9af109e51499f0e78d355db6cf4a54fe3a550c4b
First added on: Oct 08, 2026