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.

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 follo…