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Oxygen dressing shows promise for healing diabetic foot wounds

NCT ID NCT07368816

Symptom relief Sponsor: Ospedale San Donato 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 special oxygen-enriched oil-based dressing on diabetic foot ulcers that form after surgery. Forty adults with diabetes took part and were randomly assigned to get either the new dressing or standard wound care. The main goal was to see if the ulcer healed completely within 16 weeks. The study was small and designed to gather early information for future larger trials.

What this could mean

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

Active substance
oxygen-enriched oil-based wound dressing
What this could lead to
If it works, this could offer a new, simple way to help heal diabetic foot ulcers after surgery.
What could go wrong
This is a very small pilot study with only 40 people. The results are preliminary and need to be confirmed in much larger trials. It may not work better than standard care.

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

40 people

The number who actually took part.

Started

Mar 2024

Finished

Apr 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 years and older

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: * Adults (≥18 years) with diabetes mellitus * Presence of a post-surgical diabetic foot ulcer * Eligibility for topical wound treatment * Ability to provide written informed consent Exclusion Criteria: * Active malignancy * Severe systemic infection or sepsis * Known hypersensitivity to components of the wound dressing * Inability to comply with study procedures or follow-up * Participation in another interventional clinical study during the same period

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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 Postoperative wound healing

Contacts and locations

Locations

  • Diabetology and Metabolism Unit, San Donato Hospital Arezzo, Local Health Authority South-East Tuscany, iTaly

    Arezzo, AR, 52100, Italy

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