Phase 2: STIMULAN VG for Pressure Ulcer, Stage IV
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.
Official registry: https://clinicaltrials.gov/study/NCT06283979 · Biocomposites Ltd · enrollment listed as 60
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are STIMULAN VG, or Standard of Care. The registry lists allocation as randomized. 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.
They plan to enroll about 60 people at 9 sites. Taking part typically means a procedure as part of the study plus check-ins.
Official title (unrewritten)
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.
Interventions: STIMULAN VG, Standard of Care
Primary outcome (registry wording): Individual patient success and findings at the 8 week follow-up visit
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- In order to be eligible to participate in this study, subjects must meet all of the following criteria:
- Presenting with a Stage IV pressure ulcer requiring treatment of excision, bony debridement and flap coverage/primary closure
- Operative candidate for flap surgery or primary closure
- Presence of focal osteomyelitis as suggested by imaging to show extent of infection. Acceptable imaging techniques are Magnetic Resonance Imaging or CT scan
- Adults ≥ 18 years in age at the time of treatment
- Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures
- Subjects who meet any of the following criteria will be excluded from participating in this study:
Who the registry excludes
- People the protocol lists as excluded — the study team must confirm.
Public study contact (from the registry)
Keira Watts, Clinical Research Director
clinicaltrials@biocomposites.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
9 listed- Advanced Foot Care, LLC — Phoenix, Arizona (recruiting)
- Northwestern University Feinberg School of Medicine — Chicago, Illinois (recruiting)
- Henry Ford Hospital — Detroit, Michigan (recruiting)
- University of Mississippi Medical Center — Jackson, Mississippi (recruiting)
- Missouri Orthopaedic Institute — Columbia, Missouri (recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska (recruiting)
- Rutgers New Jersey Medical School — Newark, New Jersey (recruiting)
- NYU Langone Hospital - Long Island Clinical Research Center — Mineola, New York (recruiting)
- University of Pittsburgh, McGowan Institute for Regenerative Medicine — Pittsburgh, Pennsylvania (recruiting)
FAQ about this NCT record
Is NCT06283979 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06283979?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06283979?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary