Chronic Venous Leg UlcerNCT07803445
Effect of Ozonated Gel Phonophoresis on Chronic Venous Ulcer Healing
A study testing Ozonated Gel Phonophoresis, Ultrasound Therapy and Ozonated Gel in people with Chronic Venous Leg Ulcer and Venous Ulcer, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Chronic Venous Leg Ulcer, Venous Ulcer
- What is being tested?
- Ozonated Gel Phonophoresis, Ultrasound Therapy and Ozonated Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT OF OZONATED GEL PHONOPHORESIS ON HEALING OF CHRONIC VENOUS ULCERS
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Chronic Venous Leg Ulcer, Venous Ulcer
- Being tested
- Ozonated Gel Phonophoresis, Ultrasound Therapy, Ozonated Gel, Conventional Wound Care
- Keywords
- Ozone Therapy, Ozonated Gel, Phonophoresis, Ultrasound Therapy, Wound Healing, Venous Leg Ulcer, Chronic Wound
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozonated Gel PhonophoresisCombination 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)
Ultrasound TherapyDevice
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)
Ozonated GelOther
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)
Conventional Wound CareOther
Standard care including ulcer cleansing, dressing, compression, repositioning, use of support surfaces, exercise, and medication.
it's assigned to: All four arms
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Device: Ultrasound Therapy; Other: Conventional Wound Care |
| Topical Ozonated Gel Alone | Active comparator | Participants received topical ozonated gel treatment only. Receives: Combination Product: Ozonated Gel Phonophoresis; Device: Ultrasound Therapy; Other: Ozonated Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks post-treatment
Secondary outcomes (2)
Change in Wound Volume
Wound volume assessed using a sterile syringe technique, in which saline solution is injected into the wound bed until filled, with the injected volume recorded in cubic centimeters (cc).
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
Change in Wound-Related Quality of Life
Quality of life assessed using the Arabic version of the Wound Quality of Life (Wound-QoL) questionnaire, a 17-item tool scored on a 5-point Likert scale (0 = not at all, 4 = very much) across three subscales (body, psychology, everyday life), plus one standalone financial-burden item. Higher scores indicate greater quality-of-life degradation.
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Oct 2025
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous Leg UlcerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pakinam Hisham Mohamed Younis, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803445
- Sponsor's protocol ID
- P.T.REC/012/006081
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF OZONATED GEL PHONOPHORESIS ON HEALING OF CHRONIC VENOUS ULCERS
- ClinicalTrials.gov ID
- NCT07803445
- Acronym / sponsor ID
- P.T.REC/012/006081
- Conditions
- Chronic Venous Leg Ulcer, Venous Ulcer
- Keywords
- Ozone Therapy, Ozonated Gel, Phonophoresis, Ultrasound Therapy, Wound Healing, Venous Leg Ulcer, Chronic Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ozonated Gel Phonophoresis | Experimental | Combination Product: Ozonated Gel PhonophoresisParticipants 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). |
| Ultrasound Followed by Topical Ozonated Gel | Active comparator | Device: Ultrasound Therapy, Other: Ozonated GelParticipants 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. |
| Ultrasound Alone | Active comparator | Device: Ultrasound Therapy, Other: Conventional Wound CareParticipants received ultrasound therapy alone (0.5 W/cm², 1 MHz, pulsed pattern), in addition to conventional medical treatment and traditional wound care. |
| Topical Ozonated Gel Alone | Active comparator | Combination Product: Ozonated Gel Phonophoresis, Device: Ultrasound Therapy, Other: Ozonated GelParticipants received topical ozonated gel treatment only. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- - Ulcer caused by conditions such as arterial disease
- Diabetes mellitus
- Active malignancy
- Psychological instability
- Skin diseases such as eczema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ozonated Gel PhonophoresisUltrasound-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) | Combination product | Ozonated Gel Phonophoresis, Topical Ozonated Gel Alone |
| Ultrasound TherapyTherapeutic ultrasound at 0.5 W/cm², 1 MHz, pulsed mode. assigned to: Ultrasound Followed by Topical Ozonated Gel (Arm 2), Ultrasound Alone (Arm 3) | Device | Topical Ozonated Gel Alone, Ultrasound Alone, Ultrasound Followed by Topical Ozonated Gel |
| Ozonated GelTopical 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 | Topical Ozonated Gel Alone, Ultrasound Followed by Topical Ozonated Gel |
| Conventional Wound CareStandard care including ulcer cleansing, dressing, compression, repositioning, use of support surfaces, exercise, and medication. it's assigned to: All four arms | Other | Ultrasound Alone |
Primary outcome
Change in Wound Surface Area
Time frame: Baseline and 6 weeks post-treatment
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.
2 secondary outcomes
Change in Wound Volume
Time frame: Baseline (pre-treatment) and 6 weeks (post-treatment)
Change in Wound-Related Quality of Life
Time frame: Baseline (pre-treatment) and 6 weeks (post-treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozonated Gel Phonophoresis, Ultrasound Therapy and Ozonated Gel in people with Chronic Venous Leg Ulcer and Venous Ulcer, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Wound Surface Area (time frame: Baseline and 6 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.