An interventional study of Photobiomodulation Therapy and Sham Photobiomodulation in Venous Leg Ulcer (VLU), Venous Hypertension Ulcers and Chronic Venous Insufficiency, sponsored by University of Nove de Julho. Recruiting at 1 site in Brazil. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment
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.
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.
369 studies on the registry are indexed under Varicose Ulcer; 77 are open to participants now.
This study's planned enrollment of 102 is above the median of 60 across 309 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →University of Nove de Julho is the lead sponsor of 246 studies on the registry; 52 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Operational confirmation before enrollment:
Exclusion Criteria
Protocol Discontinuation Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Photobiomodulation Therapy · Procedure: Compression Therapy
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.
Device: Sham Photobiomodulation · Procedure: Compression Therapy
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.
Also known as: Low-Level Laser Therapy, Photobiomodulation, LLLT, Photobiomodulation Therapy with Low-Level Laser
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.
Also known as: Placebo Photobiomodulation, Laser Simulation, Placebo Laser Treatment, Inactive Laser Therapy
All study participants received standardized wound care and compression therapy using 30-mmHg compression stockings.
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.
Time frame: Baseline, Month 1, Month 2, and Month 4
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of the treatment period - Month 4
Plan to share: 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.
Supporting information: Study protocol
Time frame: When we have published the data
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Nov 2027, 15 months after the start.
Of 67 non-industry interventional studies with no phase under Varicose Ulcer, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 65. This study's planned 15 months is below that.
Counting every sponsor, half of 133 studies reached it within 28 months; a quarter within 13 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.