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NCT Number: NCT06746597

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Skin Thickness Skin Stiffness

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asia University

Taichung, Wufeng, 41354, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Right leg dominant
  • Can walk without help

Exclusion criteria

  • Active ulcers

Treatment and study plan

Walking intervention on plantar skin thickness and stiffness

Other

Walking intervention in three different air-insole pressures (80 mmHg, 160 mmHg, 240 mmHg) in two different walking durations (10 and 20 minutes).

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Asia University

Other

Registry information

Official study title

Evaluating Mechanical Properties Change Using Optical Coherence Tomography on Plantar Skin Layers

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 24, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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