NCT07042659

Effectiveness of Blue Light for Hard-to-heal Wounds

Completed NA Last updated 29 June 2025

What this trial tests

NA trial testing Photobiomodulation in Hard-to-heal Wounds in 11 participants. Completed in 28 February 2025.

Timeline

1 November 2024

Primary endpoint
31 January 2025

28 February 2025

Quick facts

Lead sponsor	University of Turin, Italy
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	1 November 2024
Primary completion	31 January 2025
Estimated completion	28 February 2025
Sites	1 location across Italy

Drugs / interventions tested

• Photobiomodulation

Conditions studied

• Hard-to-heal Wounds — all drugs for Hard-to-heal Wounds →
• Chronic Wounds — all drugs for Chronic Wounds →
• Wound Healing Delayed — all drugs for Wound Healing Delayed →
• Photobiomodulation Therapy — all drugs for Photobiomodulation Therapy →

Sponsor

University of Turin, Italy

Who can join

18 and older, any sex, with Hard-to-heal Wounds or Chronic Wounds. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Treatment of Wounds That Are Difficult to Heal with Photobiomodulation: A Pilot Study.
   De Angelis S, Conti A, Di Nunzio A, Stoppa P, et al · · 2025 · PMID 40724677 · DOI 10.3390/healthcare13141652