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

NCT07177274 | Active Not Recruiting DMC

• 1 other identifier: NSTC 114-2923-E-468-001-MY3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Stiffness; Wound; Skin; Low-Level Laser Therapy

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (1)

• To compare wound skin stiffness with contralateral normal skin.

  1 year

Study Arms (2)

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.

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.

Radiation: Low Level Laser Therapy

Interventions

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.

Also known as: 660 nm LLLT

Skin location (upper limb, lower limb); Skin status (normal, wound, after treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Asia University: lead

Study Sites (1)

Asia University

Taichung, Wufeng, 41354, Taiwan

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 16, 2025
• Study Start: September 19, 2024
• Primary Completion: July 24, 2025
• Study Completion: September 20, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)