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Osteomyelitis clinical trials

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NCT ID: NCT06283979 Not yet recruiting - Osteomyelitis Clinical Trials

A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.

BLADE OPU2
Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.

NCT ID: NCT06262854 Not yet recruiting - Clinical trials for Surgical Procedure, Unspecified

Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study

BIG D-FOOT
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

This study is designed as a double-blind, placebo-controlled, parallel series randomized trial aimed at verifying the effiicacy and safety of a local calcium-sulphate bio-absorbable antibiotic delivery (tobramicina+vancomicina) versus placebo (calcium-sulphate matrix without antibiotics) in patients with diabetic foot osteomyelitis treated with surgical procedures.

NCT ID: NCT06250023 Recruiting - Clinical trials for Osteomyelitis; Vertebra

SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis

SAVE
Start date: February 1, 2024
Phase:
Study type: Observational

Background The current Danish National Guideline for treatment of pyogenic vertebral osteomyelitis (PVO) recommends 6 weeks antibiotic (AB) treatment, with a 2-week intravenous (IV) AB lead-in followed by 4 weeks oral AB for uncomplicated PVO, and 12 weeks AB treatment with a 2-4-week IV AB lead-in followed by 8 weeks oral AB for complicated PVO. The primary objective of the current study is to investigate whether shortening the duration of IV AB to one week for both complicated and uncomplicated PVO is non-inferior to the current Danish National Guideline.

NCT ID: NCT06232603 Recruiting - Clinical trials for Chronic Recurrent Multifocal Osteomyelitis

Medication Adherence Intervention in Chronic Recurrent Multifocal Osteomyelitis (CRMO)

Start date: February 20, 2024
Phase: N/A
Study type: Interventional

This project aims to quantify and evaluate rates of non-adherence and barriers to medication adherence in pediatric patients with CRMO followed at Seattle Children's Hospital's robust CRMO program, which is the only clinical program in the Washington, Wyoming, Alaska, Montana, Idaho (WWAMI) region. This will be a stepped-wedge cluster-randomized trial, in which participants will be randomly assigned to one of two groups -- one which receives educational materials at the end of their first clinic visit, and the other which receives educational materials at the end of their second clinic visit. All participants will be given baseline surveys at the start of their first clinic visit, as well as follow-up surveys at the start of their second and third clinic visits. These surveys aim to evaluate rates of non-adherence and qualitative barriers to adherence, as well as efficacy of educational interventions in improving adherence rates.

NCT ID: NCT06096012 Recruiting - Osteomyelitis Clinical Trials

Don't Treat Ghosts Anti-MRSA Antibiotics in Osteomyelitis Without Identified MRSA

Start date: June 23, 2023
Phase:
Study type: Observational

Osteomyelitis is described as infection and inflammation of the long bone or bone marrow, often due to an open wound, operation, or invasive trauma.1 It is invasive and involves hematogenous seeding or contiguous spread of the infectious organism

NCT ID: NCT06084754 Recruiting - Osteomyelitis Clinical Trials

Effect of Pulsed Electromagnetic Field Stimulation on Localized Pediatric Osteomyelitis

PEMF
Start date: November 27, 2023
Phase: N/A
Study type: Interventional

This study will be applied to evaluate effect of pulsed electromagnetic field on pediatric localized osteomyelitis.

NCT ID: NCT06066801 Recruiting - Clinical trials for Subjects With Diabetes and DFU With a Suspicion of DFO

Bedside Bone Biopsy in Diabetic Foot Osteomyelitis

BOLBOC
Start date: March 14, 2024
Phase: N/A
Study type: Interventional

During their lifetime, 15 to 25% of patients with diabetes mellitus will develop a Diabetic Foot Ulcer (DFU) related to neuropathy and/or peripheral arterial disease. DFU is the leading cause of non-traumatic lower-extremity amputation worldwide. Diabetic foot osteomyelitis (DFO), which complicates up to 60% of DFU, is a major trigger of amputation in over 80% of persons with diabetes resulting in subsequent loss of quality of life. It has been shown that medical treatment of DFO may prevent amputations with early diagnosis of osteomyelitis and appropriate use of antibiotics. Empirical antimicrobial treatment is not recommended for DFO as for other chronic infections. Surgically or radiologically acquired bone sample for culture is the reference standard recommended by the International Working Group of Diabetic Foot (IWGDF) to diagnose DFO and to determine the causative bacteria and their susceptibility. However, defining appropriate antimicrobial therapy directed to the causative bacteria in DFO is challenging since it requires bone biopsy (BB) procedures which are underused in clinical practice for various reasons: lack of availability, cost, and delay. Some clinicians also find bone biopsy cumbersome or too invasive. To overcome these barriers, we have set up for a few years a bedside blind BB procedure performed by diabetologists at the bedside in the clinical ward. Since then, this method has been used in more than 200 patients with DFO in the diabetology departments of Lariboisiere Hospital and Bichat Hospital (Paris). We have recently published our observational data of 79 patients showing that bedside BB is a simple, safe and efficient procedure for the diagnosis of DFO with a similar rate of complete healing at 12 months compared to conventional surgical or radiological bone biopsies. In order to extend and confirm these preliminary and observational results, the aim of this study is to compare the efficiency and safety of bedside BB versus conventional bone biopsy in a randomized controlled trial (RCT) of patients with DFO. Our hypothesis is that bedside BB is non-inferior to conventional bone biopsy in DFO and can be used as a simpler alternative procedure to document DFO

NCT ID: NCT06010433 Not yet recruiting - Clinical trials for Diabetic Foot Osteomyelitis

CERAMENT G Device Registry

Start date: September 22, 2023
Phase:
Study type: Observational [Patient Registry]

This is an Observational Device Registry Study of CERAMENT|G in normal use in accordance with the IFU. It will run for a period of three years from enrolment of the first patient into the Study at each Site, before being subject to review. A Device Registry is a form of observational study that concerns the performance of a device in normal use. It is intended to collect data that is reflective of 'real world' device performance.

NCT ID: NCT05959590 Completed - Osteomyelitis Clinical Trials

Ferumoxytol-enhanced Imaging of Osteomyelitis

Start date: February 12, 2014
Phase: Phase 1
Study type: Interventional

Diabetic foot infections contribute to 75,000 hospitalizations in the US each year. There is a lifetime incidence of 15-25% of foot infections in diabetics. The investigators hypothesize that ferumoxytol (FDA approved for use in CKD patients, unlike gadolinium) will improve the accuracy of MR imaging in the diagnosis of osteomyelitis by allowing for the specific imaging of macrophages that have taken up the iron-based compound. In this study the investigators will image 12 patients with suspected diabetic osteomyelitis using ferumoxytol-contrasted MRI, and evaluate the feasibility of this approach.

NCT ID: NCT05867654 Not yet recruiting - Clinical trials for Osteomyelitis of Jaw

Efficacy of Oral vs IV Antibiotics in the Treatment of Orofacial Osteomyelitis

Start date: March 1, 2024
Phase:
Study type: Observational

The goal of this clinical trial is compare the efficacy of oral and IV antibiotics in the treatment of orofacial osteomyelitis. The main question it aims to answer is: Are oral antibiotics as effective as IV antibiotics in the treatment of orofacial osteomyelitis. Participants, once diagnosed with osteomyelitis, will be started on oral antibiotics for their treatment. Participants will follow up with oral and maxillofacial surgery clinic accordingly and their progression and compliance will be monitored.