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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wufeng
-
Taichung, Wufeng, Taiwan, 41354
- Asia University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Three different air-insole presures (80 mmHg, 160 mmHg, and 240 mmHg)
|
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)
|
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.
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. |
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.
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. |
Through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CRREC-112-130
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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