Evaluating Skin Changes Using Optical Coherence Tomography on Plantar Layers

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

Study Overview

• Status: Active, not recruiting
• Conditions: Skin Thickness; Skin Stiffness
• Intervention / Treatment: Other: Walking intervention on plantar skin thickness and stiffness

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Wufeng
    • Taichung, Wufeng, Taiwan, 41354
      • Asia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Right leg dominant
• Can walk without help

Exclusion Criteria:

• Active ulcers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Three different air-insole presures (80 mmHg, 160 mmHg, and 240 mmHg)	Other: Walking intervention on plantar skin thickness and stiffness; Walking intervention in three different air-insole pressures (80 mmHg, 160 mmHg, 240 mmHg) in two different walking durations (10 and 20 minutes).
Active Comparator: Two different durations (10 and 20 minutes)	Other: Walking intervention on plantar skin thickness and stiffness; Walking intervention in three different air-insole pressures (80 mmHg, 160 mmHg, 240 mmHg) in two different walking durations (10 and 20 minutes).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Asia University

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Estimated): December 22, 2025
• Study Completion (Estimated): December 22, 2025

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: OCT; walking intervention; skin thickness; skin stiffness
• Other Study ID Numbers: CRREC-112-130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No