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NCT Number: NCT07177274

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Wound - in Medical Care Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asia University

Taichung, Wufeng, 41354, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low level laser therapy

Radiation

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

Primary outcomes

  1. To evaluate changes in skin stiffness of wound tissue before and after LLLT using OCT and MyotonPRO.

    Time frame: 1 year

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Asia University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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