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Could CO2 be the key to healing stubborn diabetic wounds?

NCT ID NCT04561609

Disease control Sponsor: University Medical Centre Ljubljana 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new way to help heal chronic wounds on the legs or feet of people with diabetes. The treatment involves applying carbon dioxide gas directly to the wound to improve blood flow and oxygen release. 120 adults with diabetes and non-healing ulcers took part to see if this approach speeds up healing and reduces wound size.

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

120 people

The number who actually took part.

Started

May 2023

Finished

Sep 2025

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 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 Criteria: * confirmed diagnosis of DM Type 1 or Type 2, * confirmed diagnosis of a non-healing DFU without clinical signs of infection, * being able to provide informed consent for the participation, and Exclusion Criteria: * patients with severe comorbidities: deep vein thrombosis, chronic kidney diseases grade III and IV, chronic heart diseases NYHA (New York Heart Association) III and IV, patients with known malignant diseases, patients with progressive infection, signs of systemic infection with elevated inflammatory markers or osteomyelitis

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Conditions

The condition(s) this trial relates to.

Foot Ulcer Leg Ulcer ulcer of lower limbs

As listed by the trial registrant

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

Chronic wound of the lower limb (leg ulcer or foot ulcer)

Contacts and locations

Locations

  • Clinical Hospital Merkur, University Clinic for Diabetes, Endocrinology, and Metabolic Diseases Vuk Vrhovac, Dugi dol 4a, 10000 Zagreb

    Zagreb, Croatia, 10000, Croatia

  • General hospital Novo mesto

    Novo Mesto, Slovenia, 8000, Slovenia

  • UMCLjubljana

    Ljubljana, Ljubljana, 1000, Slovenia

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