Effect of Ozonated Gel Phonophoresis on Chronic Venous Ulcer Healing

Summary

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.

Conditions

• Chronic Venous Leg Ulcer
• Venous Ulcer

Interventions

COMBINATION_PRODUCT

Ozonated Gel Phonophoresis

Ultrasound-mediated delivery of ozonated gel (medical-grade ozone/oxygen mixture in olive oil base) at 0.5 W/cm², 1 MHz, pulsed 20% duty cycle. Assigned to Ozonated Gel Phonophoresis (Arm 1)

DEVICE

Ultrasound Therapy

Therapeutic ultrasound at 0.5 W/cm², 1 MHz, pulsed mode. assigned to: Ultrasound Followed by Topical Ozonated Gel (Arm 2), Ultrasound Alone (Arm 3)

OTHER

Ozonated Gel

Topical gel composed of medical-grade ozone (0.25% ozone / 99.75% oxygen mixture) in an olive oil base. assigned to: Ultrasound Followed by Topical Ozonated Gel (Arm 2), Topical Ozonated Gel Alone (Arm 4)

OTHER

Conventional Wound Care

Standard care including ulcer cleansing, dressing, compression, repositioning, use of support surfaces, exercise, and medication. it's assigned to: All four arms

Sponsors & Collaborators

• Cairo University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2026-08-01

Completion

2026-08-01

Countries

• Egypt

Study Locations