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.
Biocomposites Ltd
Summary
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.
Description
The trial is an open-label, multi-center, randomized (1:1), controlled phase 2 trial in patients diagnosed with stage IV pressure ulcers.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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, inclu…
Interventions
- Combination ProductSTIMULAN VG
Insertion of STIMULAN VG into the ulcer cavity prior to flap/primary closure.
- ProcedureStandard of Care
Standard of Care. Ulcer bursectomy, debridement and flap/primary closure. Peri-operative antibiotics.
Locations (9)
- Advanced Foot Care, LLCPhoenix, Arizona
- Northwestern University Feinberg School of MedicineChicago, Illinois
- Henry Ford HospitalDetroit, Michigan
- University of Mississippi Medical CenterJackson, Mississippi
- Missouri Orthopaedic InstituteColumbia, Missouri
- University of Nebraska Medical CenterOmaha, Nebraska