Effect of Photobiomodulation on Healing of Venous Leg Ulcers

NCT07123285 | Not Yet Recruiting

• 1 other identifier: CAAE88980225
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Venous Hypertension Ulcers; Venous Leg Ulcer (VLU); Chronic Venous Insufficiency; Chronic Venous Disease

Keywords

venous ulcers; photobiomodulation; Low-Level Laser Therapy; Compression Therapy; Venous Ulcer; Venous Leg Ulcer; Wound Healing

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Month 1, Month 2, and Month 4

Secondary Outcomes (8)

• Adverse events

  From the first treatment session through Week 16

• Bates-Jensen Wound Assessment Tool Score

  Baseline, Month 1, Month 2, and Month 4

• Pain intensity

  Before and after each treatment session, twice weekly for 16 weeks

• Health-Related Quality of Life

  Baseline and Month 4

• Venous Clinical Severity Score (VCSS)

  Baseline, Month 1, Month 2, and Month 4

Study Arms (2)

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.

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.

Device: Sham Photobiomodulation; Procedure: Compression Therapy

Interventions

Photobiomodulation Therapy DEVICE

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

Photobiomodulation

Compression Therapy PROCEDURE

All study participants received standardized wound care and compression therapy using 30-mmHg compression stockings.

Photobiomodulation; Sham Photobiomodulation

Sham Photobiomodulation DEVICE

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

Sham Photobiomodulation

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Estratégia Saúde da Família Vereador Carlos Alberto Baptistela - Maria Cristina

Lençóis Paulista, São Paulo, 18681-160, Brazil

Location

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Anna C Ratto Tempestini Horliana, PhD

  University of Nove de Julho

  STUDY DIRECTOR

Central Study Contacts

Rayana G Moreira, MD

CONTACT

+5514981051703; rayanamoreira@hotmail.com

Anna C Ratto Tempestini Horliana, PhD

CONTACT

+5511948002288; annacrth@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and the examiner responsible for pre- and post-procedure assessments will be blinded to allocation. The nurse administering active or sham photobiomodulation will be the only team member aware of the assigned intervention. The sham procedure will reproduce device positioning and application time; the device will remain switched off, participants will wear an eye covering, and a recorded operating sound will be played.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: August 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: When we have published the data

Locations

BR (1)