Effect of Photobiomodulation on Healing of Venous Leg Ulcers: A Double-Blind Randomized Study

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07123285
• Lead Sponsor: University of Nove de Julho

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Study Start: 2025-09-01
• Primary Completion: 2026-10-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complete healing or reduction in venous ulcer size	From enrollment to the end of the 16-week treatment period	Defined as total re-epithelialization of the wound with no drainage and no need for dressings, or a significant reduction in wound size by the end of the treatment period.

Secondary Outcome Measures

Name	Time	Method
Wound quality assessment using the Bates-Jensen Wound Assessment Tool	At baseline, week 4, week 8, and week 16	Wound quality will be assessed using the Bates-Jensen Wound Assessment Tool, which evaluates parameters such as wound size, depth, edges, exudate, and tissue type. Assessments will be conducted at four time points to monitor healing progression.
Quality of life assessment using SF-36 questionnaire	At baseline and after 16 weeks	Quality of life will be assessed using the 36-Item Short Form Survey (SF-36), covering eight health domains including physical functioning, pain, and emotional well-being.
Venous Clinical Severity Score (VCSS)	At baseline, week 4, week 8, and week 16	Assess changes in venous disease severity, including pigmentation, inflammation, skin induration, and ulcer characteristics.
Wound area measurement using ImitoWound®	At baseline, week 4, week 8, and week 16	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.
Thermography (lesion and periwound temperature)	Before and after each treatment session, twice weekly for 16 weeks	Temperature will be measured with an infrared thermographic camera at the center of the wound and at a standardized point 2 cm from the margin, before and after each session, to assess vascular response.
Total treatment cost	Cumulative from the start of treatment to the end of the 16-week treatment period	Direct treatment costs will be calculated by totaling the resources used per patient, including laser equipment use, compression therapy, dressings, debridement, and clinical supplies. Cost-effectiveness analysis will be performed between groups.
Adverse events	From the first treatment session to the end of the 16-week treatment period	Adverse events will be recorded and classified according to severity (mild, moderate, severe) and relationship to the intervention. Frequency and type of events will be analyzed for both groups.
Pain intensity measured by Visual Analog Scale (VAS)	Twice per week, over 16 weeks	Pain intensity will be measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from "no pain" to "worst pain," recorded before and after each laser or sham session. Additionally, the frequency and dosage of paracetamol (acetaminophen) use will be documented throughout the study period to assess analgesic consumption related to pain control.

Trial Locations

Locations (1)

Estratégia da Saúde da Família Monte Azul - "Antonio Benedetti".; 🇧🇷 Lençóis Paulista, São Paulo, Brazil