Venous Leg Ulcer (VLU)NCT07123285
Effect of Photobiomodulation on Healing of Venous Leg Ulcers
A study testing Photobiomodulation Therapy and Compression Therapy in people with Venous Leg Ulcer (VLU) and Venous Hypertension Ulcers, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Venous leg ulcers are a significant public health problem because of their prolonged duration, high recurrence rates, and economic, social, and quality-of-life effects. Compression therapy is the standard treatment; however, healing may remain slow. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Venous Leg Ulcer (VLU), Venous Hypertension Ulcers, Chronic Venous Insufficiency
- What is being tested?
- Photobiomodulation Therapy and Compression Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Aug 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants of either sex.
- Age 19 to 85 years.
- Lower-limb venous ulcer present for at least 6 weeks and not healed.
- Ulcer without infection at enrollment.
- Operational confirmation before enrollment:
- Venous etiology confirmed by Doppler ultrasonography demonstrating venous reflux.
- Ankle-Brachial Index ≥0.8 to exclude concomitant arterial disease.
- Written informed consent.
Who cannot join
- Ulcer of non-venous etiology.
- Pregnancy.
- Severe lower-limb arterial disease.
- Current use or initiation of another venous-ulcer treatment different from the study treatment.
- Protocol Discontinuation Criteria
- Wound worsening with onset of infection.
- Any complication during the procedure requiring discontinuation for participant safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Estratégia Saúde da Família Vereador Carlos Alberto Baptistela - Maria Cristina
Lençóis Paulista, São Paulo, 18681-160
Rayana O G. Moreira, MD, +55 14 98105-1703, rayanamoreira@hotmail.com
Rayana G Moreira, MD
About this study
Official title: Effect of Photobiomodulation on the Healing of Lower-Limb Venous Ulcers: A Randomized, Double-Blind, Controlled Clinical Trial
Venous leg ulcers are a significant public health problem because of their prolonged duration, high recurrence rates, and economic, social, and quality-of-life effects. Compression therapy is the standard treatment; however, healing may remain slow. Photobiomodulation is being investigated as an adjunctive treatment to promote tissue repair and wound healing.
This prospective, randomized, controlled, double-blind clinical trial will evaluate the efficacy of photobiomodulation combined with compression therapy in the healing of lower-limb venous leg ulcers. A total of 102 participants will be randomly allocated in a 1:1 ratio to an Experimental Group (n=51), receiving active photobiomodulation plus compression therapy, or a Control Group (n=51), receiving sham photobiomodulation plus compression therapy. Treatment will be administered twice weekly on Mondays and Thursdays for 16 weeks, totaling 32 sessions.
The primary outcome will be the percentage reduction in wound volume over 16 weeks, estimated from wound area and depth. Secondary outcomes will include percentage reduction in wound area, change in wound depth, complete wound healing, adverse events, wound quality assessed using the Bates-Jensen Wound Assessment Tool, pain intensity and rescue analgesic use, health-related quality of life assessed using the SF-36, clinical severity assessed using the Venous Clinical Severity Score, and direct treatment costs. Wound area will be measured using the ImitoWound® application.
Read the detailed description
Venous leg ulcers are chronic wounds associated with chronic venous disease, characterized by prolonged healing, frequent recurrence, pain, functional limitations, reduced quality of life, and substantial treatment costs. Compression therapy is the standard treatment for venous leg ulcers. Photobiomodulation may enhance tissue repair and is being investigated as an adjunct to standard wound care and compression therapy.
This is a prospective, randomized, controlled, double-blind, parallel-group clinical trial. A total of 102 participants with lower-limb venous ulcers will be randomly allocated in a 1:1 ratio to two groups. The Experimental Group (n=51) will receive active photobiomodulation combined with standard wound care and compression therapy. The Control Group (n=51) will receive sham photobiomodulation combined with the same standard wound care and compression therapy.
All ulcers will be cleansed with 0.9% saline solution at room temperature using the study site's standardized wound-care procedure. Devitalized tissue will be debrided when indicated. Hydrogel and alginate will be used as standard primary dressings, followed by sterile gauze, bandage, and adhesive tape as the secondary dressing. Participants will receive supplies and instructions to replace the primary and secondary dressings at home once daily. Compression therapy will consist of 30-mmHg compression stockings worn daily on the affected limb, removed only for bathing and sleeping. Participants will be instructed to maintain their usual nutritional intake, alternate isometric exercises with rest periods, elevate the lower limbs, and adopt healthy lifestyle habits.
Active photobiomodulation will be delivered with the e-Light IRL cluster device (DMC Equipamentos, Brazil; ANVISA registration No. 80030810174). The cluster contains eight emitters: four red emitters at 660 nm and four infrared emitters at 808 nm. Each emitter has an output power of 100 mW and delivers 6 J during a 60-second application, resulting in a total device output power of 800 mW. The applicator will be positioned perpendicular to the wound bed and applied by direct contact through a disposable transparent PVC film. The participant and treatment team will use appropriate protective eyewear.
Sham photobiomodulation will use the same device positioning and application duration, but the device will remain switched off without therapeutic light emission. Participants will wear an eye covering, and a recorded sound similar to the operating device will be reproduced to maintain participant blinding.
Participants will be treated twice weekly on Mondays and Thursdays for 16 weeks, totaling 32 active or sham sessions. Assessments will be performed at baseline and after 1, 2, and 4 months. Standardized wound photographs will be obtained before the protocol begins and after each treatment visit.
The primary outcome will be the percentage reduction in wound volume over 16 weeks. Wound volume will be estimated as wound area multiplied by wound depth. Wound area will be estimated using the modified ellipse formula (length × width × 0.785), and wound depth will be measured at the deepest point with a sterile graduated probe. Wounds with depth ≤0.1 cm will be methodologically classified as having a depth of 0 cm for volumetric analysis; for these flat wounds, the healing response will be evaluated using the percentage reduction in wound area.
Secondary outcomes will include percentage reduction in wound area, change in wound depth, complete wound healing, adverse events, wound quality assessed using the Bates-Jensen Wound Assessment Tool, pain intensity, rescue analgesic use, health-related quality of life assessed using the SF-36, clinical severity assessed using the Venous Clinical Severity Score, and direct treatment costs. Complete healing will be defined as total re-epithelialization without exudate, bleeding, or need for dressings for a continuous period of 2 weeks.
Data normality will be assessed using the Shapiro-Wilk test. Repeated continuous outcomes will be analyzed using repeated-measures analysis of variance with adjusted multiple comparisons when normally distributed, or the Friedman test with Dunn multiple comparisons and the Mann-Whitney test for between-group comparisons when non-normally distributed. Categorical outcomes will be analyzed using the chi-square test or Fisher's exact test. Time to complete healing will be analyzed using Kaplan-Meier survival curves and the log-rank test. An intention-to-treat analysis will be conducted for the main outcomes. Statistical significance will be set at p<0.05, with 95% confidence intervals. Analyses will be performed using SPSS version 29.
- Conditions
- Venous Leg Ulcer (VLU), Venous Hypertension Ulcers, Chronic Venous Insufficiency, Chronic Venous Disease
- Being tested
- Photobiomodulation Therapy, Sham Photobiomodulation, Compression Therapy
- Keywords
- venous ulcers, photobiomodulation, Low-Level Laser Therapy, Compression Therapy, Venous Ulcer, Venous Leg Ulcer, Wound Healing
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation TherapyDevice
Also called Low-Level Laser Therapy, Photobiomodulation, LLLT, Photobiomodulation Therapy with Low-Level Laser
The e-Light IRL cluster device (DMC Equipamentos, Brazil; ANVISA No. 80030810174) contains eight emitters: four at 660 nm and four at 808 nm. Each emitter has an output power of 100 mW and delivers 6 J over 60 seconds. Total output power is 800 mW. The applicator will be positioned perpendicular to the wound bed and applied by direct contact through disposable transparent PVC film. Appropriate protective eyewear will be used. Participants will receive active photobiomodulation twice weekly on Mondays and Thursdays for 16 weeks, totaling 32 sessions.
Sham PhotobiomodulationDevice
Also called Placebo Photobiomodulation, Laser Simulation, Placebo Laser Treatment, Inactive Laser Therapy
This intervention uses sham photobiomodulation therapy with the same laser device as in the active group, but without emitting therapeutic laser light (inactive device). The device appears identical, and the treatment sessions are conducted twice weekly over 16 weeks, totaling 32 sessions per participant. Participants also receive standard compression therapy for the management of venous leg ulcers. This sham procedure is designed to mimic the active treatment without delivering any laser energy, serving as a placebo control.
Compression TherapyProcedure or surgery
All study participants received standardized wound care and compression therapy using 30-mmHg compression stockings.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation | Experimental | The e-Light IRL cluster device (DMC Equipamentos, Brazil; ANVISA No. 80030810174) contains eight emitters: four at 660 nm and four at 808 nm. Each emitter has an output power of 100 mW and delivers 6 J over 60 seconds. Total output power is 800 mW. The applicator will be positioned perpendicular to the wound bed and applied by direct contact through disposable transparent PVC film. Appropriate protective eyewear will be used. Receives: Device: Photobiomodulation Therapy; Procedure: Compression Therapy |
| Sham Photobiomodulation | Sham comparator | The same device positioning and application duration will be used, but the device will remain switched off and will not emit therapeutic light. Participants will wear an eye covering, and a recorded sound similar to the operating device will be reproduced to maintain blinding. Receives: Device: Sham Photobiomodulation; Procedure: Compression Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Reduction in Wound Volume
Percentage reduction in wound volume over 16 weeks. Volume will be calculated as wound area (cm²) multiplied by wound depth (cm). Area will be estimated using the modified ellipse formula: length × width × 0.785. Depth will be measured at the deepest point with a sterile graduated probe. Percentage reduction will be calculated as [(baseline volume - follow-up volume) / baseline volume] × 100. For wounds with depth ≤0.1 cm, depth will be classified as zero for volumetric analysis, and healing response will be evaluated using percentage reduction in wound area.
Measured: Baseline, Month 1, Month 2, and Month 4
Secondary outcomes (8)
Adverse events
Any undesirable event related or potentially related to treatment or study procedures will be recorded and classified according to severity (mild, moderate, or severe), type, causal relationship to treatment, and frequency.
Measured: From the first treatment session through Week 16
Bates-Jensen Wound Assessment Tool Score
Wound condition will be assessed using the Bates-Jensen Wound Assessment Tool. Thirteen wound characteristics are scored from 1 to 5, resulting in a total score from 13 to 65. Higher scores indicate worse wound condition.
Measured: Baseline, Month 1, Month 2, and Month 4
Pain intensity
Local pain intensity will be measured using a 10-cm Visual Analog Scale immediately before and after each active or sham intervention. The scale ranges from 0 (no pain) to 10 (worst imaginable pain).
Measured: Before and after each treatment session, twice weekly for 16 weeks
Health-Related Quality of Life
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Eight domain scores and the Physical and Mental Component Summary scores will be calculated. Domain scores range from 0 to 100, with higher scores indicating better health status.
Measured: Baseline and Month 4
Venous Clinical Severity Score (VCSS)
Clinical severity of venous disease will be assessed using the Venous Clinical Severity Score. Ten clinical variables are scored from 0 to 3, resulting in a total score from 0 to 30. Higher scores indicate more severe venous disease.
Measured: Baseline, Month 1, Month 2, and Month 4
Wound area measurement using ImitoWound®
Ulcer area will be measured via digital photographs analyzed with the Tissue ImitoWound® mobile application, which automatically calculates wound area through image recognition and calibration.
Measured: At baseline, week 4, week 8, and week 16
Direct Treatment Cost
Direct treatment costs will include photobiomodulation, compression stockings, debridement, dressings, primary and secondary coverings, medications, and materials used. Outcomes will include total cost until complete healing, total cost through 16 weeks, mean cost per participant, and cost per unit of clinical effectiveness.
Measured: Cumulative from treatment initiation through Week 16
Complete healing
Defined as total re-epithelialization of the wound with no drainage and no need for dressings, by the end of the treatment period.
Measured: From enrollment to the end of the treatment period - Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start3 Aug 2026
- Primary completion30 Nov 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg Ulcer (VLU)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, controlled, parallel-group clinical trial with two arms: an Experimental Group receiving photobiomodulation therapy (PBM) plus compression therapy, and a Control Group receiving sham PBM plus compression therapy. Participants are allocated in a 1:1 ratio and will not cross over between groups. Each group receives 32 treatment sessions over a 16-week period.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho
- Investigators
- Anna C Ratto Tempestini Horliana, PhD, Study director, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123285
- Sponsor's protocol ID
- CAAE88980225
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I will analyze any request for access to individual participant data and will decide later whether to share it, following ethical guidelines and data privacy regulations.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Photobiomodulation on the Healing of Lower-Limb Venous Ulcers: A Randomized, Double-Blind, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07123285
- Acronym / sponsor ID
- CAAE88980225
- Conditions
- Venous Leg Ulcer (VLU), Venous Hypertension Ulcers, Chronic Venous Insufficiency, Chronic Venous Disease
- Keywords
- venous ulcers, photobiomodulation, Low-Level Laser Therapy, Compression Therapy, Venous Ulcer, Venous Leg Ulcer, Wound Healing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 14 Aug 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.
Venous leg ulcers are a significant public health problem because of their prolonged duration, high recurrence rates, and economic, social, and quality-of-life effects. Compression therapy is the standard treatment; however, healing may remain slow. Photobiomodulation is being investigated as an adjunctive treatment to promote tissue repair and wound healing.
This prospective, randomized, controlled, double-blind clinical trial will evaluate the efficacy of photobiomodulation combined with compression therapy in the healing of lower-limb venous leg ulcers. A total of 102 participants will be randomly allocated in a 1:1 ratio to an Experimental Group (n=51), receiving active photobiomodulation plus compression therapy, or a Control Group (n=51), receiving sham photobiomodulation plus compression therapy. Treatment will be administered twice weekly on Mondays and Thursdays for 16 weeks, totaling 32 sessions.
The primary outcome will be the percentage reduction in wound volume over 16 weeks, estimated from wound area and depth. Secondary outcomes will include percentage reduction in wound area, change in wound depth, complete wound healing, adverse events, wound quality assessed using the Bates-Jensen Wound Assessment Tool, pain intensity and rescue analgesic use, health-related quality of life assessed using the SF-36, clinical severity assessed using the Venous Clinical Severity Score, and direct treatment costs. Wound area will be measured using the ImitoWound® application.
Detailed description
Venous leg ulcers are chronic wounds associated with chronic venous disease, characterized by prolonged healing, frequent recurrence, pain, functional limitations, reduced quality of life, and substantial treatment costs. Compression therapy is the standard treatment for venous leg ulcers. Photobiomodulation may enhance tissue repair and is being investigated as an adjunct to standard wound care and compression therapy.
This is a prospective, randomized, controlled, double-blind, parallel-group clinical trial. A total of 102 participants with lower-limb venous ulcers will be randomly allocated in a 1:1 ratio to two groups. The Experimental Group (n=51) will receive active photobiomodulation combined with standard wound care and compression therapy. The Control Group (n=51) will receive sham photobiomodulation combined with the same standard wound care and compression therapy.
All ulcers will be cleansed with 0.9% saline solution at room temperature using the study site's standardized wound-care procedure. Devitalized tissue will be debrided when indicated. Hydrogel and alginate will be used as standard primary dressings, followed by sterile gauze, bandage, and adhesive tape as the secondary dressing. Participants will receive supplies and instructions to replace the primary and secondary dressings at home once daily. Compression therapy will consist of 30-mmHg compression stockings worn daily on the affected limb, removed only for bathing and sleeping. Participants will be instructed to maintain their usual nutritional intake, alternate isometric exercises with rest periods, elevate the lower limbs, and adopt healthy lifestyle habits.
Active photobiomodulation will be delivered with the e-Light IRL cluster device (DMC Equipamentos, Brazil; ANVISA registration No. 80030810174). The cluster contains eight emitters: four red emitters at 660 nm and four infrared emitters at 808 nm. Each emitter has an output power of 100 mW and delivers 6 J during a 60-second application, resulting in a total device output power of 800 mW. The applicator will be positioned perpendicular to the wound bed and applied by direct contact through a disposable transparent PVC film. The participant and treatment team will use appropriate protective eyewear.
Sham photobiomodulation will use the same device positioning and application duration, but the device will remain switched off without therapeutic light emission. Participants will wear an eye covering, and a recorded sound similar to the operating device will be reproduced to maintain participant blinding.
Participants will be treated twice weekly on Mondays and Thursdays for 16 weeks, totaling 32 active or sham sessions. Assessments will be performed at baseline and after 1, 2, and 4 months. Standardized wound photographs will be obtained before the protocol begins and after each treatment visit.
The primary outcome will be the percentage reduction in wound volume over 16 weeks. Wound volume will be estimated as wound area multiplied by wound depth. Wound area will be estimated using the modified ellipse formula (length × width × 0.785), and wound depth will be measured at the deepest point with a sterile graduated probe. Wounds with depth ≤0.1 cm will be methodologically classified as having a depth of 0 cm for volumetric analysis; for these flat wounds, the healing response will be evaluated using the percentage reduction in wound area.
Secondary outcomes will include percentage reduction in wound area, change in wound depth, complete wound healing, adverse events, wound quality assessed using the Bates-Jensen Wound Assessment Tool, pain intensity, rescue analgesic use, health-related quality of life assessed using the SF-36, clinical severity assessed using the Venous Clinical Severity Score, and direct treatment costs. Complete healing will be defined as total re-epithelialization without exudate, bleeding, or need for dressings for a continuous period of 2 weeks.
Data normality will be assessed using the Shapiro-Wilk test. Repeated continuous outcomes will be analyzed using repeated-measures analysis of variance with adjusted multiple comparisons when normally distributed, or the Friedman test with Dunn multiple comparisons and the Mann-Whitney test for between-group comparisons when non-normally distributed. Categorical outcomes will be analyzed using the chi-square test or Fisher's exact test. Time to complete healing will be analyzed using Kaplan-Meier survival curves and the log-rank test. An intention-to-treat analysis will be conducted for the main outcomes. Statistical significance will be set at p<0.05, with 95% confidence intervals. Analyses will be performed using SPSS version 29.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, controlled, parallel-group clinical trial with two arms: an Experimental Group receiving photobiomodulation therapy (PBM) plus compression therapy, and a Control Group receiving sham PBM plus compression therapy. Participants are allocated in a 1:1 ratio and will not cross over between groups. Each group receives 32 treatment sessions over a 16-week period.
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation | Experimental | Device: Photobiomodulation Therapy, Procedure: Compression TherapyThe e-Light IRL cluster device (DMC Equipamentos, Brazil; ANVISA No. 80030810174) contains eight emitters: four at 660 nm and four at 808 nm. Each emitter has an output power of 100 mW and delivers 6 J over 60 seconds. Total output power is 800 mW. The applicator will be positioned perpendicular to the wound bed and applied by direct contact through disposable transparent PVC film. Appropriate protective eyewear will be used. |
| Sham Photobiomodulation | Sham comparator | Device: Sham Photobiomodulation, Procedure: Compression TherapyThe same device positioning and application duration will be used, but the device will remain switched off and will not emit therapeutic light. Participants will wear an eye covering, and a recorded sound similar to the operating device will be reproduced to maintain blinding. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants of either sex.
- Age 19 to 85 years.
- Lower-limb venous ulcer present for at least 6 weeks and not healed.
- Ulcer without infection at enrollment.
- Venous etiology confirmed by Doppler ultrasonography demonstrating venous reflux.
Key exclusion criteria (7 listed)
- Ulcer of non-venous etiology.
- Pregnancy.
- Severe lower-limb arterial disease.
- Current use or initiation of another venous-ulcer treatment different from the study treatment.
- Protocol Discontinuation Criteria
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 |
|---|---|---|
| Photobiomodulation TherapyAlso: Low-Level Laser Therapy, Photobiomodulation, LLLT, Photobiomodulation Therapy with Low-Level LaserThe e-Light IRL cluster device (DMC Equipamentos, Brazil; ANVISA No. 80030810174) contains eight emitters: four at 660 nm and four at 808 nm. Each emitter has an output power of 100 mW and delivers 6 J over 60 seconds. Total output power is 800 mW. The applicator will be positioned perpendicular to the wound bed and applied by direct contact through disposable transparent PVC film. Appropriate protective eyewear will be used. Participants will receive active photobiomodulation twice weekly on Mondays and Thursdays for 16 weeks, totaling 32 sessions. | Device | Photobiomodulation |
| Sham PhotobiomodulationAlso: Placebo Photobiomodulation, Laser Simulation, Placebo Laser Treatment, Inactive Laser TherapyThis intervention uses sham photobiomodulation therapy with the same laser device as in the active group, but without emitting therapeutic laser light (inactive device). The device appears identical, and the treatment sessions are conducted twice weekly over 16 weeks, totaling 32 sessions per participant. Participants also receive standard compression therapy for the management of venous leg ulcers. This sham procedure is designed to mimic the active treatment without delivering any laser energy, serving as a placebo control. | Device | Sham Photobiomodulation |
| Compression TherapyAll study participants received standardized wound care and compression therapy using 30-mmHg compression stockings. | Procedure or surgery | Photobiomodulation, Sham Photobiomodulation |
Primary outcome
Percentage Reduction in Wound Volume
Time frame: Baseline, Month 1, Month 2, and Month 4
Percentage reduction in wound volume over 16 weeks. Volume will be calculated as wound area (cm²) multiplied by wound depth (cm). Area will be estimated using the modified ellipse formula: length × width × 0.785. Depth will be measured at the deepest point with a sterile graduated probe. Percentage reduction will be calculated as [(baseline volume - follow-up volume) / baseline volume] × 100. For wounds with depth ≤0.1 cm, depth will be classified as zero for volumetric analysis, and healing response will be evaluated using percentage reduction in wound area.
8 secondary outcomes
Adverse events
Time frame: From the first treatment session through Week 16
Bates-Jensen Wound Assessment Tool Score
Time frame: Baseline, Month 1, Month 2, and Month 4
Pain intensity
Time frame: Before and after each treatment session, twice weekly for 16 weeks
Health-Related Quality of Life
Time frame: Baseline and Month 4
Venous Clinical Severity Score (VCSS)
Time frame: Baseline, Month 1, Month 2, and Month 4
Wound area measurement using ImitoWound®
Time frame: At baseline, week 4, week 8, and week 16
Direct Treatment Cost
Time frame: Cumulative from treatment initiation through Week 16
Complete healing
Time frame: From enrollment to the end of the treatment period - Month 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. I will analyze any request for access to individual participant data and will decide later whether to share it, following ethical guidelines and data privacy regulations.
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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.
Anna C Ratto Tempestini Horliana, PhD study director
University of Nove de Julho
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 Therapy and Compression Therapy in people with Venous Leg Ulcer (VLU) and Venous Hypertension Ulcers, run by University of Nove de Julho at 1 site in Brazil.
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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rayana G Moreira, MD (+5514981051703, rayanamoreira@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Reduction in Wound Volume (time frame: Baseline, Month 1, Month 2, and Month 4). 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 9 Sep 2026.