Evaluation of Skin Stiffness Changes in Wounds Before and After Low-Level Laser Therapy

September 10, 2025 updated by: Asia University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Wufeng
      • Taichung, Wufeng, Taiwan, 41354
        • Asia university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • presented chronic and burn wounds lasting more than four weeks.
  • had partial-thickness burn wounds.

Exclusion Criteria:

  • current smokers.
  • wounds that were fresh and still bleeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Skin status (normal, wound, after treatment)
Using 660 nm LLLT efficacy on the wound, separated categories into the upper limb and lower limb.
Radiation: Low Level Laser Therapy
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.
Other Names:
  • 660 nm LLLT
Active Comparator: Skin location (upper limb, lower limb)
Using 660 nm LLLT efficacy on the wound, separated categories into the upper limb and lower limb.
Radiation: Low Level Laser Therapy
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.
Other Names:
  • 660 nm LLLT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate changes in skin stiffness of wound tissue before and after LLLT using OCT and MyotonPRO.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare wound skin stiffness with contralateral normal skin.
Time Frame: 1 year

To assess differences in stiffness response between upper-body and lower-body wound sites.

To determine the correlation between OCT and MyotonPRO stiffness measurements.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2024

Primary Completion (Actual)

July 24, 2025

Study Completion (Estimated)

September 20, 2025

Study Registration Dates

First Submitted

September 10, 2025

First Submitted That Met QC Criteria

September 10, 2025

First Posted (Estimated)

September 16, 2025

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSTC 114-2923-E-468-001-MY3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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