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Not yet recruiting NCT06628115

Post Market Study of Cerament V/G in Pedal Osteomyelitis

No phase Interventional Osteomyelitis - Foot

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cerament V or G.
Who it may be relevant to
Registry conditions: Osteomyelitis - Foot. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Post-market Study of Cerament V/G in Foot Osteomyelitis

Overview

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.

Interventions

  • Device cerament V or G
    Cerament V or G implantation into forefoot or mid foot bone, and 7-10 days of oral antibiotics.

Primary outcome measures

  • Freedom from clinical or radiological osteomyelitis in the same or adjacent bone (recorded as yes or no) [Time frame: 12 months post-implantion]
Secondary outcome measures (7)
  • 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]

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 \<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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 39182821

Identifiers

NCT: NCT06628115 · 339714

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗