Your session is about to expire
← Back to Search
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
BLADE-VG2 Trial Summary
This trial tests Stimulan-VG to treat diabetic foot osteomyelitis in the forefoot and evaluates its safety and effectiveness.
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.Check my eligibility
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.See study design
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.
BLADE-VG2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with confirmed absence of clinical signs of osteomyelitis or surgical infection at the index site
Secondary outcome measures
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 moreBLADE-VG2 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.
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.
Find a Location
Who is running the clinical trial?
MCRAIndustry Sponsor
33 Previous Clinical Trials
9,306 Total Patients Enrolled
Biocomposites LtdLead Sponsor
4 Previous Clinical Trials
210 Total Patients Enrolled
ParexelIndustry Sponsor
305 Previous Clinical Trials
101,054 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, not breastfeeding, and follow specific birth control measures.I had a limb amputated less than 30 days ago.I have a history of muscle disorders like myasthenia gravis or Parkinson's.I have a bone infection not in my forefoot.I have high calcium levels or a condition that could cause this.I have a foot infection linked to bone inflammation.My foot infection is classified as severe.I have had ulcers for over a year.I do not have any other cancer that could interfere with the trial's results or my participation.I am 18 years old or older.I need surgery to remove damaged tissue or amputation of a toe due to an infection that has spread.I am either male or female.I have severe artery problems in my arms or legs.I have been diagnosed with a bone infection in my foot due to diabetes.I am currently being treated for diabetes, either type 1 or type 2.I am able to understand and sign the consent form.My kidney function is moderately to severely reduced.I have an ulcer larger than 3.5 cm.I have not taken high doses of steroids for long periods recently.I had an amputation of part of my big toe due to a bone infection.I have a bone infection in the tip of my toe.I need ongoing antibiotics for an infection during the trial.
Research Study Groups:
This trial has the following groups:- Group 1: STIMULAN VG
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger