An interventional study of cerament V or G in Osteomyelitis - Foot, sponsored by Mid and South Essex NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Mid and South Essex NHS Foundation Trust · Not applicable, Interventional, and Treatment
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:
Participants will:
105 studies on the registry are indexed under Osteomyelitis; 30 are open to participants now.
This study's enrollment of 25 is below the median of 74 across 60 interventional studies indexed under Osteomyelitis.
Browse Osteomyelitis studies →Mid and South Essex NHS Foundation Trust is the lead sponsor of 34 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cerament V/G implantation to forefoot or mid foot.
Device: cerament V or G
Cerament V or G implantation into forefoot or mid foot bone, and 7-10 days of oral antibiotics.
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.
Time frame: 12 months post-implantion
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months post-implantation
Plan to share: Yes — Anonymised outcome data for primary and secondary endpoints to 12 months will be made available for IPD meta-analysis.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 01/11/2026 to 1/11/2036
Access criteria: Ankur Thapar
Data sharing details ↗ · www.aru.ac.uk
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Mid and South Essex NHS Foundation Trust