Effect of Ozonated Gel Phonophoresis on Chronic Venous Ulcer Healing

Overview

This study looks at whether adding ozone gel to ultrasound treatment (a method called phonophoresis) helps chronic leg wounds caused by poor vein function heal better than ultrasound or ozone gel used alone. Chronic venous leg ulcers are open sores on the lower leg that happen when the veins cannot properly return blood to the heart. They are slow to heal and can affect a person's daily life, comfort, and sleep. Ultrasound therapy is sometimes used to help push medicated gels deeper into the skin, a technique called phonophoresis. Ozone gel is a topical product that may help fight infection and support tissue repair. This study will compare four approaches to see which combination works best alongside standard wound care. Eighty men and women between 40 and 65 years old with a venous leg ulcer that has lasted more than 6 weeks will be randomly placed into one of four groups. All participants will continue to receive standard wound care (cleaning, dressing, and compression) throughout the study. Depending on their group, participants will also receive: ultrasound combined with ozone gel applied together, ultrasound followed by ozone gel applied separately, ultrasound alone, or ozone gel alone. Treatment will be given three times a week for six weeks. Researchers will measure wound size, wound depth, and quality of life before treatment and again after six weeks to see which approach helps the wounds heal best.

Background and Rationale Venous leg ulcers are the most common type of chronic lower-limb wound, accounting for approximately 70% of all leg ulcers, and they arise from venous hypertension caused by valve dysfunction, venous obstruction, or impaired calf muscle pump function. Their prevalence increases with age, reaching up to 5% in individuals over 65. These ulcers are frequently recurrent and are associated with pain, reduced mobility, sleep disturbance, and diminished quality of life. Phonophoresis uses ultrasound to enhance the transdermal delivery of topically applied agents into deeper tissue layers. Ozone, applied topically in gel form, has documented antibacterial, anti-inflammatory, antioxidant, and tissue-regenerative properties, and has shown benefit in other chronic wound applications. This study is designed to address a gap in the literature regarding the specific effect of ozonated gel delivered via phonophoresis on venous ulcer healing. Design This is a randomized controlled trial with four parallel groups (20 participants each): Group A: Ozonated gel phonophoresis (ultrasound at 0.5 W/cm², 1 MHz, pulsed mode with 20% duty cycle, applied for 5-10 minutes depending on ulcer size, with ozonated gel as the coupling medium) plus conventional wound care Group B: Ultrasound therapy followed by separate topical application of ozonated gel, plus conventional wound care Group C: Ultrasound therapy alone (0.5 W/cm², 1 MHz, pulsed mode), plus conventional wound care Group D: Topical ozonated gel alone All participants receive treatment three sessions per week for six weeks, alongside conventional medical wound care (cleansing, dressing, compression, repositioning, use of support surfaces, exercise, and medication) as applicable to their group. Outcome Assessments Measurements are taken at baseline (pre-treatment) and after six weeks (post-treatment): Wound surface area and dimensions, assessed using the ImitoMeasure smartphone-based digital planimetry application Wound volume, assessed using a sterile saline-injection technique Quality of life, assessed using the Arabic version of the Wound Quality of Life (Wound-QoL) questionnaire, a 17-item tool covering body, psychological, and everyday-life subscales Statistical Analysis Sample size (N = 80) was calculated using G\*Power (version 3.1.9.2) based on wound surface area data from prior published work, to achieve 80% power at α = 0.05 with an effect size of 0.4. Descriptive statistics and one-way MANOVA will be used to compare baseline characteristics (age, weight, height, BMI) and outcome measures across groups; chi-squared testing will compare sex distribution; paired t-tests will compare pre- and post-treatment values within each group. Significance is set at p \< 0.05.