Post Market Study of Cerament V/G in Pedal Osteomyelitis (NCT06628115) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Post Market Study of Cerament V/G in Pedal Osteomyelitis
25 participantsStarted 2024-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Freedom from clinical or radiological osteomyelitis in the same or adjacent bone (recorded as yes or no)