Effect of Ozonated Gel Phonophoresis on Chronic Venous Ulcer Healing

Background and Rationale Venous leg ulcers are the most common type of chronic lower‐limbwound, accounting for approximately 70% of all leg ulcers, and they arise from venoushypertension caused by valve dysfunction, venous obstruction, or impaired calf musclepump function. Their prevalence increases with age, reaching up to 5% in individuals over65. 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 appliedagents into deeper tissue layers. Ozone, applied topically in gel form, has documentedantibacterial, anti‐inflammatory, antioxidant, and tissue‐regenerative properties, andhas shown benefit in other chronic wound applications. This study is designed to addressa gap in the literature regarding the specific effect of ozonated gel delivered viaphonophoresis on venous ulcer healing.DesignThis 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 thecoupling medium) plus conventional wound care Group B: Ultrasound therapy followed byseparate 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 careGroup D: Topical ozonated gel aloneAll participants receive treatment three sessions per week for six weeks, alongsideconventional medical wound care (cleansing, dressing, compression, repositioning, use ofsupport surfaces, exercise, and medication) as applicable to their group.Outcome AssessmentsMeasurements are taken at baseline (pre‐treatment) and after six weeks (post‐treatment):Wound surface area and dimensions, assessed using the ImitoMeasure smartphone‐baseddigital planimetry application Wound volume, assessed using a sterile saline‐injectiontechnique 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‐lifesubscalesStatistical 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 usedto compare baseline characteristics (age, weight, height, BMI) and outcome measuresacross groups; chi‐squared testing will compare sex distribution; paired t‐tests willcompare pre‐ and post‐treatment values within each group. Significance is set at p <0.05.