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

NCT ID: NCT07177274

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-19

Study Completion Date

2025-09-20

Brief Summary

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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.

Detailed Description

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Conditions

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Wound - in Medical Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Skin status (normal, wound, after treatment)

Using 660 nm LLLT efficacy on the wound, separated categories into the upper limb and lower limb.

Group Type ACTIVE_COMPARATOR

Low Level Laser Therapy

Intervention Type 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.

Skin location (upper limb, lower limb)

Using 660 nm LLLT efficacy on the wound, separated categories into the upper limb and lower limb.

Group Type ACTIVE_COMPARATOR

Low Level Laser Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type RADIATION

Other Intervention Names

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660 nm LLLT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Asia University

Taichung, Wufeng, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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NSTC 114-2923-E-468-001-MY3

Identifier Type: -

Identifier Source: org_study_id

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