Post Market Study of Cerament V/G in Pedal Osteomyelitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteomyelitis - Foot

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Case Series

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cerament

Cerament V/G implantation to forefoot or mid foot.

Group Type EXPERIMENTAL

cerament V or G

Intervention Type DEVICE

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

Interventions

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cerament V or G

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

Intervention Type DEVICE

Eligibility Criteria

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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) \&gt; 30ml/min/1.72m2

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No