Skin ThicknessNCT07863843
Effects of Vibration Therapy on Plantar Skin Properties
A study testing Local vibration 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 in the first metatarsal head (M1) after getting local vibration treatments. The main questions it aims to answer are: How far does vibration affect the changes in epidermis layers in the M1? 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, Microcirculation
- What is being tested?
- Local vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- healthy foot plantar
Who cannot join
- active foot ulcers
- diabetes mellitus,
- peripheral vascular disease,
- hypertension, or any musculoskeletal condition affecting the lower extremity
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn if there are changes in plantar skin surface in the first metatarsal head (M1) after getting local vibration treatments.
The main questions it aims to answer are:
Read more
How far does vibration affect the changes in epidermis layers in the M1? What conditions affect the most in the plantar surface, the different vibrations or the different time assessment?
Researchers will compare the three different time assessment (immediate, 20 mins delay and 30 mins delay) in two different vibrations (50 Hz and 100 Hz) to see how far the plantar skin surface changes in thickness, stiffness, and micro circulation.
- Participants will get their M1 checked and measured by Optical coherence tomography (OCT) in thickness and stiffness before the local vibration intervention and also by Laser Doppler Flowmetry (LDF).
- Participants will lay supine throughout the experiment.
- Conditions
- Skin Thickness, Skin Stiffness, Microcirculation
- Being tested
- Local vibration
- Keywords
- OCT, Laser Doppler Flowmetry, Local vibration, Skin stiffness, Skin thickness, Microcirculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local vibrationDevice
Local vibration will be applied to the M1 region of the plantar foot at two frequencies (50 Hz and 100 Hz). Each participant will undergo assessments immediately after vibration and at 20 and 30 minutes post-intervention. Tissue thickness and stiffness will be assessed using optical coherence tomography (OCT), while microcirculation will be evaluated using laser Doppler flowmetry (LDF).
| Study group | Role | What they receive |
|---|---|---|
| Different vibration frequencies (50 Hz and 100 Hz) | Active comparator | Not described Receives: Device: Local vibration |
| Different time assessment (immediately, at 20 min, and at 30 min) | Active comparator | Not described Receives: Device: Local vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in M1 tissue thickness
Changes in M1 tissue thickness measured by OCT and analysed from OCT image calibrated in micrometer and millimeter;
All M1 changes are measured at different time frames: immediately, 20 minutes, and 30 minutes after vibration.
Measured: Through study completion, about 1 year 3 months
Changes in M1 apparent tissue stiffness
Apparent stiffness based on calculation of stratum corneum layer difference before and after local negative pressure applied using the OCT device in N/mm; All M1 changes are measured at different time frames: immediately, 20 minutes, and 30 minutes after vibration.
Measured: Through study completion, about 1 year 3 months
Changes in M1 microcirculation
Microcirculation (in Perfusion Unit (PU)) measured by Laser Doppler Flowmetry. All M1 changes are measured at different time frames: immediately, 20 minutes, and 30 minutes after vibration.
Measured: Through study completion, about 1 year 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Apr 2025
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863843
- Sponsor's protocol ID
- GIL-EL-001
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vibration Therapy on Plantar Skin Properties
- ClinicalTrials.gov ID
- NCT07863843
- Acronym / sponsor ID
- GIL-EL-001
- Conditions
- Skin Thickness, Skin Stiffness, Microcirculation
- Keywords
- OCT, Laser Doppler Flowmetry, Local vibration, Skin stiffness, Skin thickness, Microcirculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Asia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 7 Oct 2026 (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 in the first metatarsal head (M1) after getting local vibration treatments.
The main questions it aims to answer are:
How far does vibration affect the changes in epidermis layers in the M1? What conditions affect the most in the plantar surface, the different vibrations or the different time assessment?
Researchers will compare the three different time assessment (immediate, 20 mins delay and 30 mins delay) in two different vibrations (50 Hz and 100 Hz) to see how far the plantar skin surface changes in thickness, stiffness, and micro circulation.
- Participants will get their M1 checked and measured by Optical coherence tomography (OCT) in thickness and stiffness before the local vibration intervention and also by Laser Doppler Flowmetry (LDF).
- Participants will lay supine throughout the experiment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Different vibration frequencies (50 Hz and 100 Hz) | Active comparator | Device: Local vibration |
| Different time assessment (immediately, at 20 min, and at 30 min) | Active comparator | Device: Local vibration |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy foot plantar
Key exclusion criteria (4 listed)
- active foot ulcers
- diabetes mellitus,
- peripheral vascular disease,
- hypertension, or any musculoskeletal condition affecting the lower extremity
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 |
|---|---|---|
| Local vibrationLocal vibration will be applied to the M1 region of the plantar foot at two frequencies (50 Hz and 100 Hz). Each participant will undergo assessments immediately after vibration and at 20 and 30 minutes post-intervention. Tissue thickness and stiffness will be assessed using optical coherence tomography (OCT), while microcirculation will be evaluated using laser Doppler flowmetry (LDF). | Device | Different time assessment (immediately, at 20 min, and at 30 min), Different vibration frequencies (50 Hz and 100 Hz) |
Primary outcome
Changes in M1 tissue thickness
Time frame: Through study completion, about 1 year 3 months
Changes in M1 tissue thickness measured by OCT and analysed from OCT image calibrated in micrometer and millimeter; All M1 changes are measured at different time frames: immediately, 20 minutes, and 30 minutes after vibration.
Changes in M1 apparent tissue stiffness
Time frame: Through study completion, about 1 year 3 months
Apparent stiffness based on calculation of stratum corneum layer difference before and after local negative pressure applied using the OCT device in N/mm; All M1 changes are measured at different time frames: immediately, 20 minutes, and 30 minutes after vibration.
Changes in M1 microcirculation
Time frame: Through study completion, about 1 year 3 months
Microcirculation (in Perfusion Unit (PU)) measured by Laser Doppler Flowmetry. All M1 changes are measured at different time frames: immediately, 20 minutes, and 30 minutes after vibration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- 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 Local vibration 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 7 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in M1 tissue thickness (time frame: Through study completion, about 1 year 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.