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.
Recruiting now · Phase 2
Conditions studied: Pressure Ulcer, Stage IV, Osteomyelitis
In brief
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.
Key facts
- Study ID
- NCT06283979
- Run by
- Biocomposites Ltd
- People needed
- 60
- Starts
- 2025-06-15
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Advanced Foot Care, LLC — Phoenix, Arizona, United States (enrolling)
- Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States (enrolling)
- Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
- University of Mississippi Medical Center — Jackson, Mississippi, United States (enrolling)
- Missouri Orthopaedic Institute — Columbia, Missouri, United States (enrolling)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
- Rutgers New Jersey Medical School — Newark, New Jersey, United States (enrolling)
- NYU Langone Hospital - Long Island Clinical Research Center — Mineola, New York, United States (enrolling)
- University of Pittsburgh, McGowan Institute for Regenerative Medicine — Pittsburgh, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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