Effectiveness of Blue Light for Hard-to-heal Wounds

NCT07042659 | Completed

• 1 other identifier: Blue_light_chronic_wounds
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Hard-to-heal wounds-those that fail to heal despite appropriate treatment-are a growing clinical challenge, often leading to significant discomfort, reduced quality of life, and high healthcare costs. These wounds are common among older adults and individuals with chronic conditions such as venous disease, diabetes, and lymphatic disorders. Photobiomodulation, a non-invasive therapy that uses specific wavelengths of light to stimulate biological processes, has shown promise in promoting wound healing. However, its effectiveness for long-standing, treatment-resistant wounds is not yet well established. This pilot study aims to evaluate the effects of an accelerated photobiomodulation protocol using blue light in patients with hard-to-heal wounds. The study takes place in nurse-led outpatient wound care clinics within the local health authority of Turin (ASL Città di Torino, Italy), which serves a diverse urban population. Eligible patients are adults with venous, diabetic, lymphatic, or mixed etiology wounds that have remained unhealed for at least two years. Participants receive blue light photobiomodulation treatment twice weekly for four weeks, in addition to standard wound care. Each session includes direct application of blue light to the wound area, following appropriate wound bed preparation and dressing changes. The primary outcome is the reduction in wound size, measured at baseline, at the end of treatment (week 4), and at a follow-up visit (week 12). Secondary outcomes include changes in pain levels, wound exudate characteristics, and the condition of surrounding skin. Adverse events are monitored throughout the study. By testing a standardized and replicable treatment protocol, this study seeks to generate preliminary evidence on whether blue light photobiomodulation can safely and effectively enhance healing in this complex patient population. Results may inform future clinical guidelines and support the integration of photobiomodulation into routine wound care pathways.

Conditions

Hard-to-heal Wounds; Chronic Wounds; Wound Healing Delayed; Photobiomodulation Therapy

Outcome Measures

Primary Outcomes (1)

• Wound Area Change

  The primary outcome is the change in wound area (cm²) from baseline to week 12. Wound area is measured using CutiMed® Wound Navigator, a validated digital tool for wound assessment. The wound is photographed and measured at three timepoints: baseline, week 4 (end of photobiomodulation treatment), and week 12 (follow-up). The change in area is calculated as both absolute change (in cm²) and percentage change from the baseline. The outcome will assess the effectiveness of the accelerated photobiomodulation protocol in promoting long-term wound healing in patients with hard-to-heal wounds.

  Baseline, Week 4 (end of treatment), Week 12 (follow-up)

Secondary Outcomes (4)

• Pain Change

  Baseline, Week 4 (end of treatment), Week 12 (follow-up)

• Change in Wound Exudate Quantity

  Baseline, Week 4 (end of treatment), Week 12 (follow-up)

• Change in Wound Exudate Quality

  Baseline, Week 4 (end of treatment), Week 12 (follow-up)

• Change in Surrounding Skin Condition

  Baseline, Week 4 (end of treatment), Week 12 (follow-up)

Study Arms (1)

Photobiomodulation group

EXPERIMENTAL

Participants in the intervention group will receive an accelerated photobiomodulation protocol using a portable blue LED device (EmoLED™, 415 nm, 120 mW/cm², 7.2 J/cm²), applied twice weekly for 4 weeks in a nurse-led outpatient clinic. Each treatment is administered after wound bed preparation and in combination with standard wound care (cleansing, appropriate dressings, and compression therapy when indicated). Wound area, pain, exudate, and surrounding skin condition are assessed at baseline, at week 4, and at week 12 follow-up. No control arm is included.

Device: Photobiomodulation

Interventions

Photobiomodulation DEVICE

Accelerated photobiomodulation therapy using EmoLED™, a portable blue LED device (415 nm, 120 mW/cm², 7.2 J/cm²). The device delivers continuous blue light at 4 cm from the wound surface, 60 seconds per 25 cm² sub-area (120 seconds for diabetic wounds), administered twice weekly for 4 consecutive weeks. The protocol is combined with standard wound care (cleansing, dressings, compression as indicated). The intervention is designed to promote wound healing in hard-to-heal wounds by modulating inflammation, enhancing angiogenesis, fibroblast activation, and re-epithelialization. This accelerated protocol (twice weekly vs. standard weekly regimens) aims to optimize clinical outcomes in a nurse-led outpatient setting and distinguishes this intervention from lower-frequency or red/infrared-based photobiomodulation approaches.

Photobiomodulation group

Eligibility Criteria

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

You may qualify if:

• Adults aged ≥ 18 years;
• Presence of at least one hard-to-heal wound (defined as a wound unhealed despite treatment for ≥ 2 years);
• Wound etiology of venous, lymphatic, diabetic, or mixed origin (venous/lymphatic/arterial documented);
• Wound suitable for photobiomodulation treatment according to clinical evaluation;
• Ability to provide written informed consent;
• Willingness and ability to comply with the study protocol and attend scheduled visits.

You may not qualify if:

• Age \< 18 years;
• Active oncological disease;
• Wound of exclusively arterial etiology;
• Wound with active infection at the time of enrollment;
• Participation in another interventional clinical trial within the past 3 months;
• Any medical or psychological condition that, in the investigator's judgment, would interfere with study participation or pose an unacceptable risk.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

ASL Citta di Torino

Torino, 10100, Italy

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Alessio Conti, PhD

  ASL Citta di Torino

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 29, 2025
• Study Start: November 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: February 28, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)