Evaluating Skin Changes Using Optical Coherence Tomography on Plantar Layers

Asia University

Status: Active, not recruiting

Conditions: Skin Thickness; Skin Stiffness

Treatments: Other: Walking intervention on plantar skin thickness and stiffness

Study type: Interventional

Funder types: Other

Identifiers

NCT06746597

CRREC-112-130

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Right leg dominant
• Can walk without help

Exclusion criteria

• Active ulcers

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

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

Active Comparator group

Treatment:

Other: Walking intervention on plantar skin thickness and stiffness

Two different durations (10 and 20 minutes)

Active Comparator group

Treatment:

Other: Walking intervention on plantar skin thickness and stiffness