Evaluating Skin Changes Using Optical Coherence Tomography on Plantar Layers

NCT06746597 | Active Not Recruiting

• 1 other identifier: CRREC-112-130
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Thickness; Skin Stiffness

Keywords

OCT; skin thickness; skin stiffness; walking intervention

Outcome Measures

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.

  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 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.

  Through study completion, an average of 1 year

Study Arms (2)

Three different air-insole presures (80 mmHg, 160 mmHg, and 240 mmHg)

ACTIVE COMPARATOR

Other: Walking intervention on plantar skin thickness and stiffness

Two different durations (10 and 20 minutes)

ACTIVE COMPARATOR

Other: Walking intervention on plantar skin thickness and stiffness

Interventions

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).

Three different air-insole presures (80 mmHg, 160 mmHg, and 240 mmHg); Two different durations (10 and 20 minutes)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Right leg dominant
• Can walk without help

You may not qualify if:

• Active ulcers

Sponsors & Collaborators

• Asia University: lead

Study Sites (1)

Asia University

Taichung, Wufeng, 41354, Taiwan

Location

Related Links

• Related Info
• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 24, 2024
• Study Start: January 23, 2024
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)