Effectiveness of Blue Light for Hard-to-heal Wounds

NCT07042659 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-06-29

No results posted yet for this study

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

Interventions

DEVICE

Photobiomodulation

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.

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Alessio Conti, PhD · ASL Citta di Torino

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-01-31
Completion
2025-02-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07042659 on ClinicalTrials.gov