What side effects are associated with this type of intervention?

Common treatments for foot osteomyelitis, such as calcium sulfate-based antibiotic carriers like STIMULAN VG, may cause local side effects including wound drainage, inflammation, and potential allergic reactions. Systemic antibiotic treatments, often part of standard care, can lead to gastrointestinal disturbances, allergic reactions, and, in some cases, antibiotic resistance. Both treatment types aim to manage infection while minimizing adverse effects.

What prior FDA approvals exist?

The FDA has approved various treatments for foot osteomyelitis, primarily focusing on systemic antibiotics and surgical interventions. Treatments similar to STIMULAN VG, which is a calcium sulfate-based antibiotic carrier, include other local antibiotic delivery systems like PMMA (polymethyl methacrylate) beads impregnated with antibiotics. These carriers are used to deliver high local concentrations of antibiotics directly to the infection site, minimizing systemic side effects. However, specific FDA approvals for calcium sulfate-based carriers like STIMULAN VG are less documented, and their use is often based on clinical practice and smaller studies rather than large-scale FDA-approved trials.

What other types of research exist?

Promising novel alternatives to STIMULAN VG for foot osteomyelitis in 2024 include: 1) Bioactive glass-based antibiotic carriers, which offer enhanced bone regeneration and controlled antibiotic release. 2) Antimicrobial peptides (AMPs) that provide broad-spectrum activity and reduced resistance development. 3) Localized delivery systems using biodegradable polymers for sustained antibiotic release. 4) Phage therapy targeting specific bacterial strains involved in osteomyelitis. These alternatives are under investigation for their efficacy and safety in clinical settings.

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Bone Graft Substitute

Stimulan-VG + Antibiotics for Diabetic Foot Infection (BLADE-VG2 Trial)

Phase 2

Recruiting

Research Sponsored by Biocomposites Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called STIMULAN VG for patients with serious foot infections due to diabetes. The treatment involves placing a special material in the infected area during surgery and using antibiotics for a limited time. The goal is to see if this method is safe and effective compared to the usual antibiotic treatment.

Who is the study for?

Adults with diabetic foot osteomyelitis of the forefoot who need surgical debridement but not amputation. They must have diabetes, a confirmed diagnosis of DFO, and agree to contraceptive guidance if applicable. Excluded are those with muscular disorders, severe immune suppression or recent high-dose steroids use, active substance abuse, very high HbA1c levels (>12%), severe kidney issues, large ulcers (>3.5 cm), allergies to trial drugs, significant arterial disease or certain infections.

What is being tested?

The trial is testing Stimulan-VG plus standard systemic antibiotics against just the standard care for treating diabetic foot osteomyelitis in the forefoot. It aims to assess safety and measure how much better one group does compared to the other.

What are the potential side effects?

Potential side effects may include reactions related to calcium sulfate or antibiotics used (vancomycin/gentamicin), such as allergic responses or kidney problems. There's also a risk of hypercalcemia (high calcium levels) due to components in Stimulan-VG.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with confirmed absence of clinical signs of osteomyelitis or surgical infection at the index site

Secondary study objectives

Number of hospitalizations/re-hospitalizations as a result of treatment for osteomyelitis or ulceration at the index site

Number of participants discontinuing therapy prematurely due to a treatment related event

Amputation

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: STIMULAN VGExperimental Treatment2 Interventions

Participants will receive STIMULAN VG on Day 1 following surgical debridement. Systemic antibiotics for 3 days ± 2 days following the debridement surgery.

Group II: Standard of CareActive Control1 Intervention

Participants will receive Systemic antibiotics for 4-6 weeks following the debridement surgery.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for foot osteomyelitis include systemic antibiotics and local antibiotic delivery systems like STIMULAN VG, a calcium sulfate-based antibiotic carrier. Systemic antibiotics work by circulating through the bloodstream to reach the infected bone, helping to eliminate the infection. Local antibiotic delivery systems, such as STIMULAN VG, release high concentrations of antibiotics directly at the infection site, which can enhance the effectiveness of the treatment and reduce systemic side effects. This localized approach is particularly important for foot osteomyelitis patients as it ensures a higher concentration of the drug at the site of infection, potentially leading to better outcomes and faster recovery.