Wound - in Medical CareNCT07177274
Evaluation of Skin Stiffness Changes in Wounds Before and After Low-Level Laser Therapy
A study testing Low Level Laser Therapy in people with Wound - in Medical Care, run by Asia University at 1 site in Taiwan.
Trial summary
Chronic wounds and impaired healing remain a major clinical challenge, particularly in patients with diabetes, vascular disease, or age-related skin fragility. Low-level laser therapy (LLLT) at 660 nm has been reported to enhance tissue repair, reduce inflammation, and promote angiogenesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound - in Medical Care
- What is being tested?
- Low Level Laser Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Sep 2024to 20 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presented chronic and burn wounds lasting more than four weeks.
- had partial-thickness burn wounds.
Who cannot join
- current smokers.
- wounds that were fresh and still bleeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Skin Stiffness Changes in Wounds Before and After Low-Level Laser Therapy Using 660 nm Laser: A Comparative Analysis With OCT and MyotonPRO
Chronic wounds and impaired healing remain a major clinical challenge, particularly in patients with diabetes, vascular disease, or age-related skin fragility. Low-level laser therapy (LLLT) at 660 nm has been reported to enhance tissue repair, reduce inflammation, and promote angiogenesis. However, the biomechanical properties of wound tissue following LLLT remain poorly understood.
Optical Coherence Tomography (OCT) provides a non-invasive, high-resolution method to assess skin microstructure and elasticity, while the MyotonPRO offers quantitative stiffness measurements at the tissue surface. Combining these two complementary modalities may provide a more comprehensive assessment of wound healing progression and treatment response.
This study aims to evaluate changes in wound stiffness before and after 660 nm LLLT and to compare them against contralateral normal skin, thereby providing objective insight into the biomechanical efficacy of laser treatment.
- Conditions
- Wound - in Medical Care
- Being tested
- Low Level Laser Therapy
- Keywords
- Stiffness, Wound, Skin, Low-Level Laser Therapy
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyRadiation
Also called 660 nm LLLT
Collecting wound stiffness data using the OCT-air-jet and Myoton Pro before and after the LLLT treatment using the device's indentation system. Then the intervention is applying LLLT to the wound for 3 min. The LLLT utilized the Red Dot Laser Diode Module Class IIIA.
| Study group | Role | What they receive |
|---|---|---|
| Skin status (normal, wound, after treatment) | Active comparator | Using 660 nm LLLT efficacy on the wound, separated categories into the upper limb and lower limb. Receives: Radiation: Low Level Laser Therapy |
| Skin location (upper limb, lower limb) | Active comparator | Using 660 nm LLLT efficacy on the wound, separated categories into the upper limb and lower limb. Receives: Radiation: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate changes in skin stiffness of wound tissue before and after LLLT using OCT and MyotonPRO.
Measured: 1 year
Secondary outcomes (1)
To compare wound skin stiffness with contralateral normal skin.
To assess differences in stiffness response between upper-body and lower-body wound sites.
To determine the correlation between OCT and MyotonPRO stiffness measurements.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start19 Sep 2024
- Primary completion24 Jul 2025
- Study completion20 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound - in Medical CareStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- NCT07177274
- Sponsor's protocol ID
- NSTC 114-2923-E-468-001-MY3
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramadhan GT, Jan YK, Liau BY, Cheng HT, Shen WC, Tai CC, Pravin SC, Venkataramani K, Lee WC, Ching CTS, Lung CW. Deep Learning-Based OCT Segmentation for Stiffness Quantification in Evaluating Low-Level Laser Therapy for Wound Healing. J Biophotonics. 2026 Jun;19(6):e70291. doi: 10.1002/jbio.70291.
PubMed 42252133
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Skin Stiffness Changes in Wounds Before and After Low-Level Laser Therapy Using 660 nm Laser: A Comparative Analysis With OCT and MyotonPRO
- ClinicalTrials.gov ID
- NCT07177274
- Acronym / sponsor ID
- NSTC 114-2923-E-468-001-MY3
- Conditions
- Wound - in Medical Care
- Keywords
- Stiffness, Wound, Skin, Low-Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Asia UniversityUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 16 Sep 2025 (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.
Chronic wounds and impaired healing remain a major clinical challenge, particularly in patients with diabetes, vascular disease, or age-related skin fragility. Low-level laser therapy (LLLT) at 660 nm has been reported to enhance tissue repair, reduce inflammation, and promote angiogenesis. However, the biomechanical properties of wound tissue following LLLT remain poorly understood.
Optical Coherence Tomography (OCT) provides a non-invasive, high-resolution method to assess skin microstructure and elasticity, while the MyotonPRO offers quantitative stiffness measurements at the tissue surface. Combining these two complementary modalities may provide a more comprehensive assessment of wound healing progression and treatment response.
This study aims to evaluate changes in wound stiffness before and after 660 nm LLLT and to compare them against contralateral normal skin, thereby providing objective insight into the biomechanical efficacy of laser treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin status (normal, wound, after treatment) | Active comparator | Radiation: Low Level Laser TherapyUsing 660 nm LLLT efficacy on the wound, separated categories into the upper limb and lower limb. |
| Skin location (upper limb, lower limb) | Active comparator | Radiation: Low Level Laser TherapyUsing 660 nm LLLT efficacy on the wound, separated categories into the upper limb and lower limb. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- presented chronic and burn wounds lasting more than four weeks.
- had partial-thickness burn wounds.
Key exclusion criteria (2 listed)
- current smokers.
- wounds that were fresh and still bleeding.
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 |
|---|---|---|
| Low Level Laser TherapyAlso: 660 nm LLLTCollecting wound stiffness data using the OCT-air-jet and Myoton Pro before and after the LLLT treatment using the device's indentation system. Then the intervention is applying LLLT to the wound for 3 min. The LLLT utilized the Red Dot Laser Diode Module Class IIIA. | Radiation | Skin location (upper limb, lower limb), Skin status (normal, wound, after treatment) |
Primary outcome
To evaluate changes in skin stiffness of wound tissue before and after LLLT using OCT and MyotonPRO.
Time frame: 1 year
1 secondary outcome
To compare wound skin stiffness with contralateral normal skin.
Time frame: 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 16 Sep 2025.
- Derived from this study: PubMed 42252133Ramadhan GT, Jan YK, Liau BY, Cheng HT, Shen WC, Tai CC, Pravin SC, Venkataramani K, Lee WC, Ching CTS, Lung CW. Deep Learning-Based OCT Segmentation for Stiffness Quantification in Evaluating Low-Level Laser Therapy for Wound Healing. J Biophotonics. 2026 Jun;19(6):e70291. doi: 10.1002/jbio.70291.
- 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 Low Level Laser Therapy in people with Wound - in Medical Care, 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 2 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 16 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?
To evaluate changes in skin stiffness of wound tissue before and after LLLT using OCT and MyotonPRO. (time frame: 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 NCT07177274, which also lists 1 linked publication.
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 16 Sep 2025.