Effect of Photobiomodulation on Healing of Venous Leg Ulcers

NCT ID: NCT07123285

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-02-01

Brief Summary

This randomized, controlled, double-blind clinical trial will evaluate the efficacy of photobiomodulation (PBM) combined with compression therapy in the healing of venous ulcers (VUs) in the lower limbs. A total of 104 participants will be allocated into two groups: Experimental Group (PBM + compression) and Control Group (sham PBM + compression). Treatments will be administered twice weekly for 16 weeks (32 sessions). The primary outcome will be complete wound healing. Secondary outcomes include changes in ulcer area and volume, pain (VAS), quality of life (SF-36), clinical severity (VCSS), wound quality (Bates-Jensen Scale), infrared thermography, and treatment costs. Data will be analyzed using ANOVA or Kruskal-Wallis, chi-square or Fisher's exact test, and Kaplan-Meier survival analysis, with a significance level of p < 0.05.

Detailed Description

Venous ulcers (VUs) represent a significant public health problem, characterized by prolonged duration, high recurrence rates, and economic, social, and quality-of-life impacts on affected patients. Currently, the most commonly used conventional treatment for VUs includes topical agents, pharmacotherapy, and compression therapy. Photobiomodulation (PBM) has been widely utilized in wound healing techniques, accelerating the healing process and improving patients' quality of life. This study aims to evaluate the efficacy of PBM combined with compression therapy (gold standard) in the healing time of VUs in the lower limbs. This will be a prospective, randomized, controlled, double-blind clinical trial. A total of 104 participants with venous ulcers in the lower limbs will be randomized into two groups: the Experimental Group (n=52), which will receive compression therapy combined with PBM (6 J per emitter, 4 emitters at 660 nm and 808 nm, total power of 400 mW, 100 mW per emitter, twice a week), and the Control Group (n=52), which will receive compression therapy and sham PBM. Patients will be treated twice a week (Monday and Wednesday) as per the routine of the wound care room at the Lençóis Paulista Health Unit. The researcher will conduct the treatment in collaboration with a trained and calibrated nurse. Each patient will receive 32 PBM or sham PBM sessions. Outcomes will be assessed weekly by the same researcher over 16 weeks. If positive results are observed, participants will be invited to undergo the experimental group treatment. At the end of the study, the primary outcome will be complete healing, defined as total re-epithelialization of the skin without drainage or the need for dressings (16 weeks). Secondary outcomes will include changes in wound size (area and volume), the rate of ulcer size reduction, adverse effects, and additional evaluations such as wound quality assessed by the Bates-Jensen Scale, pain intensity measured by the Visual Analog Scale (VAS), and quality of life assessed using the SF-36 questionnaire. Additional analyses will include wound temperature measurement using infrared thermography, clinical changes assessed by the Venous Clinical Severity Score (VCSS), and treatment costs. For objective wound size analysis, the Tissue Analytics® application will be used, enabling automatic measurements through digital images captured via smartphones. Data will be analyzed after assessing normality using either a two-way ANOVA or the Kruskal-Wallis test. Categorical variables will be compared using the chi-square test or Fisher's exact test. Survival analysis for the primary outcome will be conducted using the Kaplan-Meier method and the log-rank test. A significance level of p < 0.05 will be considered.

Conditions

Venous Disease; Venous Insufficiency (Chronic)(Peripheral); Venous Insufficiency of Leg; Venous Leg Ulcer (VLU); Venous Leg Ulcer; Venous Hypertension Ulcers; Varicose Ulcers; Varicose Ulcer of Lower Limb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Photobiomodulation plus Compression Therapy

Participants in this arm will receive photobiomodulation therapy using a low-level laser device with 4 emitters operating at 660 nm and 808 nm wavelengths. Each emitter delivers 6 Joules of energy at 100 mW power. Treatment sessions are conducted twice weekly (Monday and Wednesday) for 16 weeks, totaling 32 sessions. In addition, standard compression therapy will be applied as per clinical guidelines for venous leg ulcers.

Group Type: EXPERIMENTAL

Photobiomodulation plus Compression Therapy

Intervention Type: DEVICE

This intervention uses a low-level laser device with 8 emitters, including 4 red emitters at 660 nm and 4 infrared emitters at 808 nm. Each emitter delivers 6 Joules of energy at 100 mW power, with a total power output of 800 mW. Treatment is administered twice weekly over 16 weeks, totaling 32 sessions per participant. The device is used in combination with standard compression therapy for venous leg ulcer management.

Compression Therapy plus Sham Photobiomodulation

Participants in this arm will receive sham photobiomodulation therapy using the same laser device but without active laser emission (placebo). Treatment sessions are also conducted twice weekly for 16 weeks, totaling 32 sessions. They will also receive standard compression therapy as per clinical guidelines for venous leg ulcers.

Group Type: SHAM_COMPARATOR

Compression Therapy plus Sham Photobiomodulation

Intervention Type: DEVICE

This intervention uses a sham photobiomodulation therapy with the same laser device used in the active group but without emission of 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 venous leg ulcer management. This sham procedure is designed to mimic the active treatment without delivering any laser energy, serving as a placebo control.

Interventions

Photobiomodulation plus Compression Therapy

This intervention uses a low-level laser device with 8 emitters, including 4 red emitters at 660 nm and 4 infrared emitters at 808 nm. Each emitter delivers 6 Joules of energy at 100 mW power, with a total power output of 800 mW. Treatment is administered twice weekly over 16 weeks, totaling 32 sessions per participant. The device is used in combination with standard compression therapy for venous leg ulcer management.

Intervention Type: DEVICE

Compression Therapy plus Sham Photobiomodulation

This intervention uses a sham photobiomodulation therapy with the same laser device used in the active group but without emission of 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 venous leg ulcer management. This sham procedure is designed to mimic the active treatment without delivering any laser energy, serving as a placebo control.

Intervention Type: DEVICE

Other Intervention Names

Low-Level Laser Therapy; Photobiomodulation; LLLT; Photobiomodulation Therapy with Low-Level Laser; Placebo Photobiomodulation; Laser Simulation; Placebo Laser Treatment; Inactive Laser Therapy

Eligibility Criteria

Inclusion Criteria

• Patients of both sexes;
• Individuals with venous ulcers in the lower limbs for at least three weeks that have not healed;
• Age between 18 and 85 years;
• Residents of Lençóis Paulista or nearby regions.

Exclusion Criteria

• Patients with ulcers of non-venous etiology;
• Pregnant women;
• Presence of severe arterial disease in the lower limbs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Anna Carolina Ratto Tempestini Horliana

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna C Ratto Tempestini Horliana, PhD

Role: STUDY_DIRECTOR

University of Nove de Julho

Locations

Estratégia da Saúde da Família Monte Azul - "Antonio Benedetti".

Lençóis Paulista, São Paulo, Brazil

Countries

Brazil

Central Contacts

Rayana G Moreira, MD

Role: CONTACT

rayanamoreira@hotmail.com

+5514981051703

Anna C Ratto Tempestini Horliana, PhD

Role: CONTACT

annacrth@gmail.com

+5511948002288

Facility Contacts

Ivana O Segura Constanço

Role: primary

ivanaottoboni@hotmail.com

+551432644042 ext. +5514998212434

Other Identifiers

CAAE88980225

Identifier Type: -

Identifier Source: org_study_id