Skin ThicknessNCT06746597
Evaluating Skin Changes Using Optical Coherence Tomography on Plantar Layers
A study testing Walking intervention on plantar skin thickness and stiffness in people with Skin Thickness and Skin Stiffness, run by Asia University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Thickness, Skin Stiffness
- What is being tested?
- Walking intervention on plantar skin thickness and stiffness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Jan 2024to 22 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right leg dominant
- Can walk without help
Who cannot join
- Active ulcers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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
- Being tested
- Walking intervention on plantar skin thickness and stiffness
- Keywords
- OCT, skin thickness, skin stiffness, walking intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking intervention on plantar skin thickness and stiffnessOther
Walking intervention in three different air-insole pressures (80 mmHg, 160 mmHg, 240 mmHg) in two different walking durations (10 and 20 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Three different air-insole presures (80 mmHg, 160 mmHg, and 240 mmHg) | Active comparator | Not described Receives: Other: Walking intervention on plantar skin thickness and stiffness |
| Two different durations (10 and 20 minutes) | Active comparator | Not described Receives: Other: Walking intervention on plantar skin thickness and stiffness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start23 Jan 2024
- Primary completion22 Dec 2025 (estimated)
- Study completion22 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skin ThicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746597
- Sponsor's protocol ID
- CRREC-112-130
- Status last verified
- Sep 2025
- First submitted
- 9 Dec 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prisilla AA, Jan YK, Liau BY, Tai CC, Ramadhan GT, Pravin SC, Venkataramani K, Lee WC, Ching CTS, Lung CW. Assessing Plantar Skin Epidermal Layer in Response to Various Insole Hardness via Deep Learning Enabled Optical Coherence Tomography Analysis. J Biophotonics. 2026 Aug;19(8):e70330. doi: 10.1002/jbio.70330.
PubMed 42549579Prisilla AA, Haris F, Jan YK, Liau BY, Shen WC, Hsieh CW, Chao WH, Lien CM, Lung CW. Investigating plantar soft tissue elasticity modulation using air insoles during walking. BMC Musculoskelet Disord. 2026 Jan 8;27(1):102. doi: 10.1186/s12891-025-09427-9.
PubMed 41507900
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Mechanical Properties Change Using Optical Coherence Tomography on Plantar Skin Layers
- ClinicalTrials.gov ID
- NCT06746597
- Acronym / sponsor ID
- CRREC-112-130
- Conditions
- Skin Thickness, Skin Stiffness
- Keywords
- OCT, skin thickness, skin stiffness, walking intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Asia UniversityUniversity, hospital or other
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 22 Dec 2025 (estimated)
- Study completion
- 22 Dec 2025 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Right leg dominant
- Can walk without help
Key exclusion criteria (1 listed)
- Active ulcers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking intervention on plantar skin thickness and stiffnessWalking intervention in three different air-insole pressures (80 mmHg, 160 mmHg, 240 mmHg) in two different walking durations (10 and 20 minutes). | Other | Three different air-insole presures (80 mmHg, 160 mmHg, and 240 mmHg), Two different durations (10 and 20 minutes) |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Derived from this study: PubMed 42549579Prisilla AA, Jan YK, Liau BY, Tai CC, Ramadhan GT, Pravin SC, Venkataramani K, Lee WC, Ching CTS, Lung CW. Assessing Plantar Skin Epidermal Layer in Response to Various Insole Hardness via Deep Learning Enabled Optical Coherence Tomography Analysis. J Biophotonics. 2026 Aug;19(8):e70330. doi: 10.1002/jbio.70330.
- Derived from this study: PubMed 41507900Prisilla AA, Haris F, Jan YK, Liau BY, Shen WC, Hsieh CW, Chao WH, Lien CM, Lung CW. Investigating plantar soft tissue elasticity modulation using air insoles during walking. BMC Musculoskelet Disord. 2026 Jan 8;27(1):102. doi: 10.1186/s12891-025-09427-9.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking intervention on plantar skin thickness and stiffness in people with Skin Thickness and Skin Stiffness, run by Asia University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06746597, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.