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Post Market Study of Cerament V/G in Pedal Osteomyelitis

NCT06628115 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-10-04

No results posted yet for this study

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

Interventions

DEVICE

cerament V or G

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

Sponsors & Collaborators

  • BONESUPPORT AB

    collaborator INDUSTRY

  • Mid and South Essex NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Ankur Thapar · Mid and South Essex NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-10-01
Completion
2026-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06628115 on ClinicalTrials.gov