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NCT Number: NCT07042659

Effectiveness of Blue Light for Hard-to-heal Wounds

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASL Citta di Torino

Torino, 10100, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Wound Area Change

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

    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.

Secondary outcomes

  1. Pain Change

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

    Pain intensity reported by participants using a 0-10 Numeric Rating Scale (NRS). Pain is assessed at each treatment session, at the end of photobiomodulation treatment (week 4), and at week 12 follow-up. Change in pain score over time will be analyzed.

  2. Change in Wound Exudate Quantity

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

    Wound exudate quantity is assessed by nurses using a 4-point Likert scale (0 = absent; 1 = scarce; 2 = moderate; 3 = abundant). Assessed at each treatment session, at week 4, and at week 12 follow-up to monitor wound response to treatment.

  3. Change in Wound Exudate Quality

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

    Wound exudate quality is assessed by nurses using a 4-point Likert scale (0 = clear; 1 = slightly bloody; 2 = bloody; 3 = purulent). Assessed at each treatment session, at week 4, and at week 12 follow-up to evaluate wound progression and infection status.

  4. Change in Surrounding Skin Condition

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

    Condition of skin surrounding the wound is assessed by nurses using a 4-point Likert scale (0 = healthy pink; 1 = slightly reddened; 2 = reddened; 3 = inflamed). Assessed at each treatment session, at week 4, and at week 12 to monitor local inflammation and skin integrity.

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Effectiveness of an Accelerated Photobiomodulation Protocol With Blue Light in Patients With Hard-to-heal Wounds: a Single-arm Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2025
Registry last updated
Jun 29, 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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