Effect of Ozonated Gel Phonophoresis on Chronic Venous Ulcer Healing

NCT07803445 | Completed

• 1 other identifier: P.T.REC/012/006081
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ozone Therapy; Ozonated Gel; Phonophoresis; Ultrasound Therapy; Wound Healing; Venous Leg Ulcer; Chronic Wound

Outcome Measures

Primary Outcomes (1)

• Change in Wound Surface Area

  Wound length, width, and surface area assessed using the ImitoMeasure smartphone-based digital planimetry application, with an adhesive calibration marker placed adjacent to the wound.

  Baseline and 6 weeks post-treatment

Secondary Outcomes (2)

• Change in Wound Volume

  Baseline (pre-treatment) and 6 weeks (post-treatment)

• Change in Wound-Related Quality of Life

  Baseline (pre-treatment) and 6 weeks (post-treatment)

Study Arms (4)

Ozonated Gel Phonophoresis

EXPERIMENTAL

Participants received ozonated gel phonophoresis (ultrasound at 0.5 W/cm², 1 MHz frequency, pulsed mode with 20% duty cycle, applied for 5-10 minutes depending on ulcer size, using ozonated gel as the coupling medium), three sessions per week for six weeks, in addition to conventional medical treatment and traditional wound care (cleansing, dressing, compression, repositioning, use of support surfaces, exercise, and medication).

Combination Product: Ozonated Gel Phonophoresis

Ultrasound Followed by Topical Ozonated Gel

ACTIVE COMPARATOR

Participants received ultrasound therapy followed by separate topical application of ozonated gel, three sessions per week for six weeks, in addition to conventional medical treatment and traditional wound care.

Device: Ultrasound Therapy; Other: Ozonated Gel

Ultrasound Alone

ACTIVE COMPARATOR

Participants received ultrasound therapy alone (0.5 W/cm², 1 MHz, pulsed pattern), in addition to conventional medical treatment and traditional wound care.

Device: Ultrasound Therapy; Other: Conventional Wound Care

Topical Ozonated Gel Alone

ACTIVE COMPARATOR

Participants received topical ozonated gel treatment only.

Combination Product: Ozonated Gel Phonophoresis; Device: Ultrasound Therapy; Other: Ozonated Gel

Interventions

Ozonated Gel Phonophoresis COMBINATION_PRODUCT

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)

Ozonated Gel Phonophoresis; Topical Ozonated Gel Alone

Ultrasound Therapy DEVICE

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)

Topical Ozonated Gel Alone; Ultrasound Alone; Ultrasound Followed by Topical Ozonated Gel

Ozonated Gel OTHER

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)

Topical Ozonated Gel Alone; Ultrasound Followed by Topical Ozonated Gel

Conventional Wound Care OTHER

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

Ultrasound Alone

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age range between 40 and 65 years
• Male and female patients
• Diagnosed with venous ulceration based on clinical investigation
• Venous ulcer presenting for more than 6 weeks
• Willing and able to provide informed consent
• Available for pre-treatment and post-treatment assessment

You may not qualify if:

• \- Ulcer caused by conditions such as arterial disease
• Diabetes mellitus
• Active malignancy
• Psychological instability
• Skin diseases such as eczema
• Life-threatening disorders, including renal failure, myocardial infarction, and autoimmune diseases

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Giza Governorate, Egypt

Location

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Assistant at October university for modern arts and sciencs

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: October 1, 2025
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-08

Locations

EG (1)