Evaluating Skin Changes Using Optical Coherence Tomography on Plantar Layers

NCT ID: NCT06746597

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-23

Study Completion Date

2025-12-22

Brief Summary

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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

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Conditions

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Skin Thickness Skin Stiffness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

Group Type ACTIVE_COMPARATOR

Walking intervention on plantar skin thickness and stiffness

Intervention Type OTHER

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

Two different durations (10 and 20 minutes)

Group Type ACTIVE_COMPARATOR

Walking intervention on plantar skin thickness and stiffness

Intervention Type OTHER

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

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Right leg dominant
* Can walk without help

Exclusion Criteria

* Active ulcers
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Asia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Asia University

Taichung, Wufeng, Taiwan

Site Status

Countries

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Taiwan

Related Links

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Other Identifiers

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CRREC-112-130

Identifier Type: -

Identifier Source: org_study_id

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