Can ozone and ultrasound team up to heal stubborn leg ulcers?
NCT ID NCT07803445
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This trial asks whether adding ozone gel to ultrasound treatment helps chronic venous leg ulcers heal better than either treatment alone. Venous leg ulcers are open sores that occur when leg veins fail to return blood to the heart, and they can be slow to heal. Researchers will compare four approaches in 80 adults aged 40 to 65 with ulcers lasting over six weeks: ultrasound plus ozone gel together, ultrasound followed by ozone gel, ultrasound alone, or ozone gel alone. All participants receive standard wound care, and the team measures wound size, depth, and quality of life before and after six weeks of treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ozonated gel (medical-grade ozone in olive oil) delivered via ultrasound phonophoresis, compared with ultrasound alone, ozone gel alone, or ultrasound followed by ozone gel.
- What this could lead to
- If it works, this could point toward a faster, non-invasive way to heal chronic venous leg ulcers and improve quality of life.
- What could go wrong
- This is a small, early-stage trial with no phase designation, so results may not hold up in larger studies. The treatment may not speed healing, and ultrasound or ozone gel could cause skin irritation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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80 people
The number who actually took part.
- Started
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Oct 2025
- Finished
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Aug 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * \- 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cairo University
Giza, Giza Governorate, Egypt
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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