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.

Launched by BIOCOMPOSITES LTD · Feb 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called STIMULAN VG to see if it is safe and effective for patients with severe pressure ulcers (Stage IV) that are also infected in the bone, a condition known as osteomyelitis. The trial will compare this new treatment, which includes the use of STIMULAN VG along with standard treatment methods like cleaning the wound and antibiotics, against the usual standard of care that involves just the cleaning and antibiotics.

To participate, individuals must be at least 18 years old and have a Stage IV pressure ulcer that needs surgical treatment. They should also have signs of bone infection confirmed by imaging tests like an MRI or CT scan. However, certain people will not be eligible, such as those with severe immune system issues or specific health conditions that could complicate treatment. If someone qualifies and joins the trial, they will receive the assigned treatment and will need to follow the study plan closely, including attending scheduled visits and following instructions from the research team. The trial is currently not recruiting participants, but it aims to gather important information that could help improve care for patients with these serious wounds.

Gender

ALL

Eligibility criteria

• In order to be eligible to participate in this study, subjects must meet all of the following criteria:
• • 1. Presenting with a Stage IV pressure ulcer requiring treatment of excision, bony debridement and flap coverage/primary closure.
• • 2. Operative candidate for flap surgery or primary closure.
• • 3. Presence of focal osteomyelitis as suggested by imaging to show extent of infection. Acceptable imaging techniques are Magnetic Resonance Imaging or CT scan.
• • 4. Adults ≥ 18 years in age at the time of treatment.
• • 5. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
• • 6. Ability of the subject or legal authorized representative to provide voluntary, signed and dated informed consent prior to any study-related procedures.
• Subjects who meet any of the following criteria will be excluded from participating in this study:
• • 1. Reasons contributing to pressure ulcer cannot be addressed.
• • 2. Severe immunological compromised patients as determined by the clinician.
• • 3. Patients with diffuse or widespread pelvic osteomyelitis that is not amenable to adequate margins for debridement.
• • 4. Patients presenting with head pressure ulcers.
• • 5. Current or recent history (within last 2 years) of active substance abuse (e.g., recreational drugs, narcotics, or alcohol) that in the judgement of the investigator, may compromise the participant's safety/recovery or ability to follow the trial procedures.
• • 6. Current smoker.
• • 7. Diabetic patient with Hba1C level above 9.
• • 8. Allergy to any component of the investigational product, such as calcium sulfate, glycopeptide antibiotics (Vancomycin), or aminoglycoside antibiotics (Gentamicin).
• • 9. Concurrent involvement in a study of another investigational product.
• • 10. Pregnant or planning to become pregnant during study period.
• • 11. Flexion contractures where patient cannot passively get full extension.
• • 12. Uncontrolled muscle spasms.
• • 13. Unable to comply with bedrest restriction or offloading requirements
• • 14. Unable to provide consent.
• • 15. Fecal or urinary incontinence with contamination of the wound.
• • 16. Lower extremity pressure ulcer location that is vascularly compromised as defined by an Ankle Brachial Index ≤ 0.7 mm Hg OR toe brachial index ≤ 0.6 mm OR toe pressure ≤ 40 mm Hg OR transcutaneous oximetry ≤ 40 mm Hg \*
• • 17. Investigator considers the participant to be clinically malnourished.
• • 18. Any conditions with known hypercalcemia (\> 10.3 mg/dl) or posing a significant risk for developing hypercalcemia (i.e., Hyperparathyroidism).
• • 19. Investigator believes trial participation may compromise safety of the participant or trial results.
• • Patients presenting with lower extremity pressure ulcers that are vascularly compromised can be rescreened followed successful revascularization