Post Market Study of Cerament V/G in Pedal Osteomyelitis

NCT06628115 | Not Yet Recruiting

• 1 other identifier: 339714
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteomyelitis - Foot

Keywords

osteomyelitis; antimicrobial; bone void filler; cerament

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months post-implantion

Secondary Outcomes (7)

• Surgical site infection requiring further course of antibiotics (recorded as yes or no)

  12 months post-implantion

• Major or minor amputation of study limb (recorded as yes or no with amputation details)

  12 months post-implantion

• Serious adverse events related to Cerament V/G (number and type of event are recorded)

  12 months post implantation

• Total treatment costs for osteomyelitis (total cost is calculated in GB pounds)

  12 months post-implantation

• Wound healing (recorded as yes or no)

  12 months post-implantation

Study Arms (1)

Cerament

EXPERIMENTAL

Cerament V/G implantation to forefoot or mid foot.

Device: cerament V or G

Interventions

cerament V or G DEVICE

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

Cerament

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead
• BONESUPPORT AB: collaborator

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Osteomyelitis

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Ankur Thapar

  Mid and South Essex NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nishita R Gadi

CONTACT

+441268 524900; nishita.gadi1@nhs.net

Georgina Beeter

CONTACT

Georgina.Beetar@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case Series

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 4, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 01/11/2026 to 1/11/2036
• Access Criteria: Ankur Thapar