Osteomyelitis - FootCerament 2NCT06628115
Post Market Study of Cerament V/G in Pedal Osteomyelitis
A study testing cerament V or G in people with Osteomyelitis - Foot, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to look at the outcomes of patients who have had bone infection of their feet treated with a licensed antibiotic paste. The main question it aims to answer is: How does the bone infection heal in response to the antibiotic paste? Participants will: Undergo standard surgery to remove… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis - Foot
- What is being tested?
- cerament V or G
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2024to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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) \&gt; 30ml/min/1.72m2
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Mid and South Essex NHS Foundation Trust
Basildon, Essex, SS16 5NL
About this study
Official title: Post-market Study of Cerament V/G in Foot Osteomyelitis
The goal of this clinical trial is to look at the outcomes of patients who have had bone infection of their feet treated with a licensed antibiotic paste. The main question it aims to answer is:
- How does the bone infection heal in response to the antibiotic paste?
Read more
Participants will:
- Undergo standard surgery to remove dead bone and drain any pus.
- Antibiotic paste is injected directly into the middle of the bone at surgery. This is instead of receiving antibiotics directly into their bloodstream for 6 weeks.
- Recieve one week of tablet antibiotics.
- Visit clinic 1 month after surgery for a normal clinical appointment. After, a research team member will ask the participant a few questions. The participant will also have a foot x-ray, wound photograph and fill out a short questionnaire.
- Visit clinic 6 months and 12 months following the surgery. A research team member will ask the participant a few questions. The participant will also have a foot x-ray, wound photograph and fill out a short questionnaire.
- Conditions
- Osteomyelitis - Foot
- Being tested
- cerament V or G
- Keywords
- osteomyelitis, antimicrobial, bone void filler, cerament
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerament V or GDevice
Cerament V or G implantation into forefoot or mid foot bone, and 7-10 days of oral antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Cerament | Experimental | Cerament V/G implantation to forefoot or mid foot. Receives: Device: cerament V or G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from clinical or radiological osteomyelitis in the same or adjacent bone (recorded as yes or no)
Clinical osteomyelitis:
positive bone biopsy in the setting of bone necrosis or purulent fluid containing pathogenic organisms emanating from exposed bone end.
Radiological osteomyelitis:
osteolysis or periosteal reaction on radiograph in affected or adjacent bone(s).
This is checked at each follow up visit, at 1, 6 and 12 months post-implantation.
Measured: 12 months post-implantion
Secondary outcomes (7)
Surgical site infection requiring further course of antibiotics (recorded as yes or no)
If there is infection at the surgical site, requiring a further course of antibiotics, this will be recorded.
Measured: 12 months post-implantion
Major or minor amputation of study limb (recorded as yes or no with amputation details)
If major or minor amputation of study limb occurs, this will be recorded.
Measured: 12 months post-implantion
Serious adverse events related to Cerament V/G (number and type of event are recorded)
A serious adverse event (SAE) refers to any expected or unexpected adverse event, related to ceramist, that results in any of the following outcomes: death, a life-threatening adverse event, requires inpatient hospitalisation (not required as part of the treatment) or prolongation of existing hospitalisation, a persistent or significant disability or incapacity, or cancer, or a congenital anomaly or birth defect.
Measured: 12 months post implantation
Total treatment costs for osteomyelitis (total cost is calculated in GB pounds)
Treatment costs will be collected through the use of a Client Service Research Inventory focussed on surgical, community and further treatment costs over a 12 month follow up. These will be recorded by the patient as they occur and checked at each visit and cross reference with hospital medical records.
Measured: 12 months post-implantation
Wound healing (recorded as yes or no)
Wound is considered healed at 100% epithelialisation. This is checked at each follow up visit, at 1, 6 and 12 months post-implantation.
Measured: 12 months post-implantation
Wound area (measured in cm^2)
Wound area is measured at each follow up visit, at 1,6 and 12 months post-implantation, using an app called Imito measure.
Measured: 12 months post-implantation
Quality of life (measured using the EQ-5D questionnaire)
Quality of life is measured using the EQ-5D questionnaire. It is conducted at each follow up visit, at 1, 6 and 12 months post-implantation.
Measured: 12 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Oct 2024
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteomyelitis - FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case Series
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- BONESUPPORT AB
- Responsible party
- Sponsor
- Investigators
- Ankur Thapar, Principal investigator, Mid and South Essex NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628115
- Sponsor's protocol ID
- 339714
- Acronym
- Cerament 2
- Status last verified
- Aug 2026
- First submitted
- 24 Sep 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised outcome data for primary and secondary endpoints to 12 months will be made available for IPD meta-analysis.
Publications
Venkateswaran V, Tiruveedhula M, Edwards J, Dindyal S, Mulcahy M, Thapar A. Antibiotic Eluting Bone Void Filler Versus Systemic Antibiotics For Pedal Osteomyelitis. J Foot Ankle Surg. 2025 Jan-Feb;64(1):30-35. doi: 10.1053/j.jfas.2024.08.010. Epub 2024 Aug 23.
PubMed 39182821
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Study of Cerament V/G in Foot Osteomyelitis
- ClinicalTrials.gov ID
- NCT06628115
- Acronym / sponsor ID
- Cerament 2 / 339714
- Conditions
- Osteomyelitis - Foot
- Keywords
- osteomyelitis, antimicrobial, bone void filler, cerament
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Collaborators
- BONESUPPORT AB
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to look at the outcomes of patients who have had bone infection of their feet treated with a licensed antibiotic paste. The main question it aims to answer is:
- How does the bone infection heal in response to the antibiotic paste?
Participants will:
- Undergo standard surgery to remove dead bone and drain any pus.
- Antibiotic paste is injected directly into the middle of the bone at surgery. This is instead of receiving antibiotics directly into their bloodstream for 6 weeks.
- Recieve one week of tablet antibiotics.
- Visit clinic 1 month after surgery for a normal clinical appointment. After, a research team member will ask the participant a few questions. The participant will also have a foot x-ray, wound photograph and fill out a short questionnaire.
- Visit clinic 6 months and 12 months following the surgery. A research team member will ask the participant a few questions. The participant will also have a foot x-ray, wound photograph and fill out a short questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case Series
| Arm | Type | Receives |
|---|---|---|
| Cerament | Experimental | Device: cerament V or GCerament V/G implantation to forefoot or mid foot. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cerament V or GCerament V or G implantation into forefoot or mid foot bone, and 7-10 days of oral antibiotics. | Device | Cerament |
Primary outcome
Freedom from clinical or radiological osteomyelitis in the same or adjacent bone (recorded as yes or no)
Time frame: 12 months post-implantion
Clinical osteomyelitis: positive bone biopsy in the setting of bone necrosis or purulent fluid containing pathogenic organisms emanating from exposed bone end. Radiological osteomyelitis: osteolysis or periosteal reaction on radiograph in affected or adjacent bone(s). This is checked at each follow up visit, at 1, 6 and 12 months post-implantation.
7 secondary outcomes
Surgical site infection requiring further course of antibiotics (recorded as yes or no)
Time frame: 12 months post-implantion
Major or minor amputation of study limb (recorded as yes or no with amputation details)
Time frame: 12 months post-implantion
Serious adverse events related to Cerament V/G (number and type of event are recorded)
Time frame: 12 months post implantation
Total treatment costs for osteomyelitis (total cost is calculated in GB pounds)
Time frame: 12 months post-implantation
Wound healing (recorded as yes or no)
Time frame: 12 months post-implantation
Wound area (measured in cm^2)
Time frame: 12 months post-implantation
Quality of life (measured using the EQ-5D questionnaire)
Time frame: 12 months post-implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 39182821Venkateswaran V, Tiruveedhula M, Edwards J, Dindyal S, Mulcahy M, Thapar A. Antibiotic Eluting Bone Void Filler Versus Systemic Antibiotics For Pedal Osteomyelitis. J Foot Ankle Surg. 2025 Jan-Feb;64(1):30-35. doi: 10.1053/j.jfas.2024.08.010. Epub 2024 Aug 23.
- Individual participant dataSharing planned: Yes. Anonymised outcome data for primary and secondary endpoints to 12 months will be made available for IPD meta-analysis.
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FDG-PET Imaging in Complicated Diabetic Foot
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New Diagnostic Tool (MinION) for Identifying Microorganisms in Foot Wounds of Patients Living With Diabetic Foot Osteomyelitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ankur Thapar principal investigator
Mid and South Essex NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cerament V or G in people with Osteomyelitis - Foot, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from clinical or radiological osteomyelitis in the same or adjacent bone (recorded as yes or no) (time frame: 12 months post-implantion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06628115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.