Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 96 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.
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 96 participants with venous ulcers in the lower limbs will be randomized into two groups: the Experimental Group (n=48), 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=48), 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photobiomodulation plus Compression Therapy | Experimental | 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. |
|
| Compression Therapy plus Sham Photobiomodulation | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photobiomodulation plus Compression Therapy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete healing or reduction in venous ulcer size | 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. | From enrollment to the end of the 16-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 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. | From the first treatment session to the end of the 16-week treatment period |
| Wound quality assessment using the Bates-Jensen Wound Assessment Tool |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rayana G Moreira, MD | Contact | +5514981051703 | rayanamoreira@hotmail.com | |
| Anna C Ratto Tempestini Horliana, PhD | Contact | +5511948002288 | annacrth@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Anna C Ratto Tempestini Horliana, PhD | University of Nove de Julho | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Estratégia da Saúde da Família Monte Azul - "Antonio Benedetti". | Lençóis Paulista | São Paulo | 18682768 | Brazil |
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.
When we have published the data
Not provided
Not provided
Not provided
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.
Not provided
Not provided
In this double-blind study, both the participants and the outcome assessors are blinded to the treatment assignments. However, the nurse administering the photobiomodulation therapy is not blinded and knows the group allocation in order to correctly perform the intervention.
|
|
| Compression Therapy plus Sham Photobiomodulation | 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. |
|
|
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. |
| At baseline, week 4, week 8, and week 16 |
| Pain intensity measured by Visual Analog Scale | Pain intensity will be measured using the Visual Analog Scale (VAS). The VAS is a 10-centimeter line anchored by two extremes: 0 = "no pain" and 10 = "worst imaginable pain." Higher scores indicate greater pain intensity (worse outcome). Measurements will be recorded before and after each laser or sham session. In addition, the frequency and total dosage of paracetamol (acetaminophen) use will be documented throughout the study period to evaluate analgesic consumption related to pain control. | Twice per week, over 16 weeks |
| Quality of life assessment using SF-36 questionnaire | Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36), which evaluates eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, vitality, emotional well-being, social functioning, pain, and general health perceptions. Each domain score ranges from 0 to 100, with higher scores indicating better health status and quality of life. | At baseline and after 16 weeks |
| Venous Clinical Severity Score (VCSS) | Venous disease severity will be assessed using the Venous Clinical Severity Score (VCSS). The VCSS includes 10 clinical domains: pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulcers, size of active ulcers, and use of compression therapy. Each domain is scored from 0 (absent/normal) to 3 (severe), resulting in a total score ranging from 0 to 30. Higher scores indicate greater venous disease severity (worse outcome). | At baseline, week 4, week 8, and week 16 |
| 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. | At baseline, week 4, week 8, and week 16 |
| Total treatment cost | 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. | Cumulative from the start of treatment to the end of the 16-week treatment period |
| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014648 | Varicose Veins |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
Not provided
Not provided