A Multi-center, Randomized (1:1), Controlled Phase II Trial of STIMULAN VG With Debridement and a Course of Systemic Antibiotics vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.

199723

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.

2024-04-01

2024-12-01

2025-12-01

Not yet recruiting

Early phase I

60

Inclusion 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 ulcers requiring treatment of excision, bony debridement and flap coverage. 2. Operative candidate for flap surgery. 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. Exclusion Criteria: 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. Patients receiving primary closure 3. Severe immunological compromised patients as determined by the clinician. 4. Patients with diffuse or widespread pelvic osteomyelitis that is not amenable to adequate margins for debridement. 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. 14. Unable to provide consent. 15. Fecal or urinary incontinence with contamination of the wound. 16. Unable to achieve wheelchair and cushion offloading of pressure wound prior to surgery - as demonstrated by pressure mapping. 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2024-02-29