Clinical trial NCT06628115: Post Market Study of Cerament V/G in Pedal Osteomyelitis
Official title: Post-market Study of Cerament V/G in Foot Osteomyelitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteomyelitis - Foot
Keywords: osteomyelitis
antimicrobial
bone void filler
cerament
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: BONESUPPORT AB
First posted: 2024-10-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case Series
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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;amp \&lt;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) \&amp;gt; 30ml/min/1.72m2

Primary outcomes:
measure: Freedom from clinical or radiological osteomyelitis in the same or adjacent bone (recorded as yes or no)
timeFrame: 12 months post-implantion
Secondary outcomes:
measure: Surgical site infection requiring further course of antibiotics (recorded as yes or no)
timeFrame: 12 months post-implantion
measure: Major or minor amputation of study limb (recorded as yes or no with amputation details)
timeFrame: 12 months post-implantion
measure: Serious adverse events related to Cerament V/G (number and type of event are recorded)
timeFrame: 12 months post implantation
measure: Total treatment costs for osteomyelitis (total cost is calculated in GB pounds)
timeFrame: 12 months post-implantation
measure: Wound healing (recorded as yes or no)
timeFrame: 12 months post-implantation
measure: Wound area (measured in cm^2)
timeFrame: 12 months post-implantation
measure: Quality of life (measured using the EQ-5D questionnaire)
timeFrame: 12 months post-implantation
Other outcomes:
Locations:
Study officials:
affiliation: Mid and South Essex NHS Foundation Trust
name: Ankur Thapar
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.