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Stimulan-VG + Antibiotics for Diabetic Foot Infection (BLADE-VG2 Trial)
BLADE-VG2 Trial Summary
This trial tests Stimulan-VG to treat diabetic foot osteomyelitis in the forefoot and evaluates its safety and effectiveness.
BLADE-VG2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BLADE-VG2 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: STIMULAN VG
- Group 2: Standard of Care
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Is there a high degree of risk associated with Stimulan-VG?
"The safety of Stimulan-VG, which is a Phase 2 medication, has been assessed to be a two as there is clinical evidence suggesting its security; however, no data exists in regards to efficacy."
Is there an ongoing recruitment process for participants in this trial?
"Confirmed. The information on clinicaltrials.gov demonstrates that the trial, which went live on January 23rd 2023, is presently looking for 60 patients across 2 sites to participate in this research endeavour."
How many participants are being monitored within this research trial?
"Affirmative. The clinicaltrials.gov portal reveals that this study is currently recruiting, having been first published on January 23rd 2023 and most recently updated February 1st of the same year. Two medical facilities are searching for 60 patients to take part in the trial."
What is the intended outcome of this trial?
"As per the study sponsor, Parexel, the primary outcome that will be evaluated at Week 24 is a lack of clinical indications for osteomyelitis. Additionally, secondary metrics such as relative changes in Cardiff Wound Impact Schedule quality-of-life assessments (CWIS QoL), number of participants who underwent an amputation at the index site and those with adverse events are also being monitored. CWIS QoL encompasses domains like social life, wellbeing and physical symptoms to determine overall scores between 0 (lowest) and 100 (highest)."
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