Post Market Study of Cerament V/G in Pedal Osteomyelitis (Cerament 2)
August 18, 2026 updated by: Mid and South Essex NHS Foundation Trust
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?
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 Overview
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Essex
-
Basildon, Essex, United Kingdom, SS16 5NL
- Mid and South Essex NHS Foundation Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 & <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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cerament
Cerament V/G implantation to forefoot or mid foot.
|
Cerament V or G implantation into forefoot or mid foot bone, and 7-10 days of oral antibiotics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
12 months post-implantion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical site infection requiring further course of antibiotics (recorded as yes or no)
Time Frame: 12 months post-implantion
|
If there is infection at the surgical site, requiring a further course of antibiotics, this will be recorded.
|
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
|
If major or minor amputation of study limb occurs, this will be recorded.
|
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
|
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.
|
12 months post implantation
|
|
Total treatment costs for osteomyelitis (total cost is calculated in GB pounds)
Time Frame: 12 months post-implantation
|
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.
|
12 months post-implantation
|
|
Wound healing (recorded as yes or no)
Time Frame: 12 months post-implantation
|
Wound is considered healed at 100% epithelialisation.
This is checked at each follow up visit, at 1, 6 and 12 months post-implantation.
|
12 months post-implantation
|
|
Wound area (measured in cm^2)
Time Frame: 12 months post-implantation
|
Wound area is measured at each follow up visit, at 1,6 and 12 months post-implantation, using an app called Imito measure.
|
12 months post-implantation
|
|
Quality of life (measured using the EQ-5D questionnaire)
Time Frame: 12 months post-implantation
|
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.
|
12 months post-implantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ankur Thapar, Mid and South Essex NHS Foundation Trust
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2024
Primary Completion (Actual)
August 1, 2026
Study Completion (Actual)
August 1, 2026
Study Registration Dates
First Submitted
September 24, 2024
First Submitted That Met QC Criteria
October 3, 2024
First Posted (Actual)
October 4, 2024
Study Record Updates
Last Update Posted (Actual)
August 19, 2026
Last Update Submitted That Met QC Criteria
August 18, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 339714
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymised outcome data for primary and secondary endpoints to 12 months will be made available for IPD meta-analysis.
IPD Sharing Time Frame
01/11/2026 to 1/11/2036
IPD Sharing Access Criteria
Ankur Thapar
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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