Post Market Study of Cerament V/G in Pedal Osteomyelitis (Cerament 2)

October 3, 2024 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

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

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 Contact

Study Contact Backup

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.
Device: cerament V or G
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.

Sponsor

Mid and South Essex NHS Foundation Trust

Collaborators

BONESUPPORT AB

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.

General Publications

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 (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 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)

October 4, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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