Can antibiotic paste heal bone infections without IV drips?

NCT ID NCT06628115

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study looks at whether placing an antibiotic paste directly into the infected bone during surgery can cure foot bone infections. Adults with foot osteomyelitis will receive the paste instead of six weeks of intravenous antibiotics, followed by a short course of oral antibiotics. Researchers will track healing through clinic visits, x-rays, and questionnaires over a year to see if the infection clears.

What this could mean

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

Active substance
Cerament V or G, an antibiotic paste implanted into the bone during surgery
What this could lead to
If successful, this approach could offer a less burdensome treatment for foot bone infections, potentially reducing the need for prolonged intravenous antibiotics and lowering amputation risk.
What could go wrong
This is a small, post-market study, so results may not be definitive. The infection could persist or recur, and there are risks of allergic reactions to the antibiotics or surgical complications.

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

25 people

The number who actually took part.

Started

Oct 2024

Finished

Aug 2026

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: * 18 years + * Informed consent * Operated on for foot sepsis with limb salvage intent. * Positive bone biopsy from forefoot or midfoot or positive pus culture from exposed bone * Adequate vascularity (1+ palpable pedal pulse, biphasic or triphasic ankle waveforms, or successful revascularisation procedure same admission) * Compliant with offloading footwear and diabetic medication Exclusion Criteria: * Allergy or contraindication to gentamicin/vancomycin * Life expectancy \&amp \<1 year * Unable to make follow up appointments at study centre. * Patients with necrotizing infections * Gentamicin or vancomycin resistant organism * Untreated peripheral arterial disease in angiosome of wound. * Buerger's disease * Vasculitides * Systemic immunosuppressive therapy * Pregnancy * Breastfeeding * Untreated thyrotoxicosis * Mysathenia gravis * Calcium metabolism disorder * Patients taking metformin with estimated glomerular filtration rate (eGFR) \> 30ml/min/1.72m2

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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

  • Mid and South Essex NHS Foundation Trust

    Basildon, Essex, SS16 5NL, United Kingdom

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