Hard-to-heal WoundsNCT07042659
Effectiveness of Blue Light for Hard-to-heal Wounds
A study testing Photobiomodulation in people with Hard-to-heal Wounds and Chronic Wounds, run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hard-to-heal Wounds, Chronic Wounds, Wound Healing Delayed
- What is being tested?
- Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Accelerated Photobiomodulation Protocol With Blue Light in Patients With Hard-to-heal Wounds: a Single-arm Clinical Trial
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.
Read more
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.
- Being tested
- Photobiomodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4 (end of treatment), Week 12 (follow-up)
Secondary outcomes (4)
Pain Change
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.
Measured: Baseline, Week 4 (end of treatment), Week 12 (follow-up)
Change in Wound Exudate Quantity
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.
Measured: Baseline, Week 4 (end of treatment), Week 12 (follow-up)
Change in Wound Exudate Quality
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.
Measured: Baseline, Week 4 (end of treatment), Week 12 (follow-up)
Change in Surrounding Skin Condition
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.
Measured: Baseline, Week 4 (end of treatment), Week 12 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Nov 2024
- Primary completion31 Jan 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hard-to-heal WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessio Conti, PhD, Principal investigator, ASL Citta di Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042659
- Sponsor's protocol ID
- Blue_light_chronic_wounds
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given the small sample size and potential identifiability of individual cases, individual participant data will not be publicly shared. Aggregate data may be made available upon reasonable request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Accelerated Photobiomodulation Protocol With Blue Light in Patients With Hard-to-heal Wounds: a Single-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT07042659
- Acronym / sponsor ID
- Blue_light_chronic_wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation group | Experimental | Device: PhotobiomodulationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationAccelerated 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. | Device | Photobiomodulation group |
Primary outcome
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.
4 secondary outcomes
Pain Change
Time frame: Baseline, Week 4 (end of treatment), Week 12 (follow-up)
Change in Wound Exudate Quantity
Time frame: Baseline, Week 4 (end of treatment), Week 12 (follow-up)
Change in Wound Exudate Quality
Time frame: Baseline, Week 4 (end of treatment), Week 12 (follow-up)
Change in Surrounding Skin Condition
Time frame: Baseline, Week 4 (end of treatment), Week 12 (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No. Given the small sample size and potential identifiability of individual cases, individual participant data will not be publicly shared. Aggregate data may be made available upon reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessio Conti, PhD principal investigator
ASL Citta di Torino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Hard-to-heal Wounds and Chronic Wounds, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Area Change (time frame: Baseline, Week 4 (end of treatment), Week 12 (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.