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Can ozone gas help heal diabetic foot wounds?

NCT ID NCT05977309

Disease control Sponsor: Asmat Burhan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether applying ozone gas to diabetic foot ulcers helps them heal faster. 430 people with diabetic foot ulcers received either standard wound care plus ozone therapy or standard care alone. The treatment was given every three days for a total of eight sessions. The study measured wound size, skin oxygen levels, and infection to see if ozone made a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
topical ozone therapy (device)
What this could lead to
If it works, this could offer a simple, low-cost addition to standard wound care for diabetic foot ulcers.
What could go wrong
This is a single completed trial with mixed evidence. Ozone therapy may not speed healing and could cause skin irritation or other side effects.

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

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

430 people

The number who actually took part.

Started

Aug 2023

Finished

Dec 2023

Lead sponsor

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

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion standarts: * Patients with diabetic foot ulcers, both male and female, include both sexes. * Size wound 4-80cm * Value toe brachial index between 4-7 mmHg * Value transcutaneous oxygen (TcPO2) levels range 1-45 mmHg * Infection, area of cellulitis 1-2cm Exclusion standarts: * Immunodeficiency conditions * Concurent ilness * Size wound \>80cm * Value toe brachial index (TBI) \<4 mmHg * Value crititcal for transcutaneous oxygen (TcPO2) is 0 mmHg * Systemic infection and sepsis

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Conditions

The condition(s) this trial relates to.

Diabetic Foot

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic foot ulcer OZONE Wound heal

Contacts and locations

Locations

  • Griya Husada Clinic

    Kediri, Indonesia, 64118, Indonesia

More trials for these conditions

Other studies related to the condition(s) this trial covers.