Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2025-12-24 @ 2:48 PM
NCT ID:
NCT07042659
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.
Study:
NCT07042659
Study Brief:
Protocol Section:
NCT07042659