Evaluating Skin Changes Using Optical Coherence Tomography on Plantar Layers

Not Applicable

Recruiting

• Conditions: Skin Thickness; Skin Stiffness

• Registration Number: NCT06746597
• Lead Sponsor: Asia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-23
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-01-22
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Right leg dominant
• Can walk without help

Exclusion Criteria

• Active ulcers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measurements of the Stratum Corneum and Deeper Epidermis are recorded in micrometers (for thickness) by comparing baseline values before walking to those obtained after the intervention.	Through study completion, an average of 1 year	The study involves six walking conditions, each combining one of three air-insole pressures (80 mmHg, 160 mmHg, and 240 mmHg) with either a 10- or 20-minute duration. Each participant completes two conditions daily with a mandatory rest of at least 20 minutes between sessions. Participants can complete all conditions for at least three days by doing two sessions daily or six days with one session per day. This structured approach ensures consistent data collection while minimizing participant fatigue.; The stratum corneum thickness is measured from the top layer of the stratum corneum to the lower border of the stratum corneum. The deeper epidermis is measured from the lower border of the stratum corneum until the lower border between the epidermis and dermis.

Secondary Outcome Measures

Name	Time	Method
Measurements of the Stratum Corneum and Deeper Epidermis are recorded in megapascal (MPa) or kilopascal (kPa) units (for stiffness) by comparing baseline values before walking to those obtained after the intervention.	Through study completion, an average of 1 year	The study involves six walking conditions, each combining one of three air-insole pressures (80 mmHg, 160 mmHg, and 240 mmHg) with either a 10- or 20-minute duration. Each participant completes two conditions daily with a mandatory rest of at least 20 minutes between sessions. Participants can complete all conditions for at least three days by doing two sessions daily or six days with one session per day. This structured approach ensures consistent data collection while minimizing participant fatigue.; The epidermis stiffness is measured by analyzing the changes on the skin after receiving negative pressure suction in 30 kPa from the OCT device.

Trial Locations

Locations (1)

Asia University; 🇨🇳 Taichung, Wufeng, Taiwan