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Bone injection may beat IV for preventing amputation infections in diabetics

NCT ID NCT07338773

Disease control Sponsor: Başakşehir Çam & Sakura City Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 5 times

Summary

This study tests whether giving the antibiotic vancomycin directly into the bone (intraosseous) during diabetic foot amputation works better than the standard IV method to prevent surgical site infections. It includes 40 adults with diabetes who need a below-knee amputation. Researchers will measure antibiotic levels at the wound and track infections, kidney function, and need for repeat surgeries over 90 days.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

40 people

The number who actually took part.

Started

Aug 2025

Finished

Jun 2026

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Age 18 years or older * Diagnosis of diabetes mellitus * Diabetic foot infection with distal ischemia * Scheduled to undergo below-knee amputation * Absence of a feasible further revascularization option, as determined by the cardiovascular surgery and interventional radiology teams * Adequate circulation at and proximal to the planned below-knee amputation level for stump healing * Ability to provide written informed consent Exclusion Criteria: * Documented allergy or hypersensitivity to vancomycin or cephalosporins * Dialysis dependence * Systemic vancomycin use within 48 hours before surgery * Previous Syme amputation or more proximal amputation * Planned amputation at a level other than below the knee * Incomplete perioperative pharmacokinetic sampling

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Diabetic Foot

As listed by the trial registrant

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

Diabetic amputation foot wound Diabetic foot disease Diabetic foot infection

Contacts and locations

Locations

  • Basaksehir Cam ve Sakura City Hospital

    Istanbul, Istanbul, 34010, Turkey (Türkiye)

More trials for these conditions

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