Evaluating Skin Changes Using Optical Coherence Tomography on Plantar Layers

The goal of this clinical trial is to learn if there are changes in plantar skin surface walking intervention in different air-insole pressures and durations. The main questions it aims to answer are: How far does walking intervention affect the changes in epidermis layers? What conditions affect the most in the plantar surface, the different air-insole pressures or the different durations? Researchers will compare the use of three different air-insole pressures (80 mmHg, 160 mmHg, and 240 mmHg) in two different durations (10 and 20 minutes) to see how far the plantar skin surface changes in thickness and stiffness. Participants will: Get their plantar region checked and measured by Optical coherence tomography in thickness and stiffness before the walking intervention. Walk with a custom-made shoe using adjusted air-insole pressures (80 mmHg, 160 mmHg, and 240 mmHg) in two different durations (10 and 20 minutes) Get their plantar region checked and measured by Optical coherence tomography in thickness and stiffness after the walking intervention.

NCT Number	NCT06746597
Lead Sponsor	Asia University
Conditions	Skin Thickness, Skin Stiffness
Enrollment	20 participants
Start Date	2024-01-23
Primary Completion	2025-12-22 (estimated)
Study Completion	2025-12-22 (estimated)
Updated on ClinicalTrials.gov	2025-09-10