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.
Phase 2
Recruiting
- Conditions
- OsteomyelitisPressure Ulcer, Stage IV
- Interventions
- Combination Product: STIMULAN VGProcedure: Standard of Care
- Registration Number
- NCT06283979
- Lead Sponsor
- Biocomposites Ltd
- Brief 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.
- Detailed Description
The trial is an open-label, multi-center, randomized (1:1), controlled phase 2 trial in patients diagnosed with stage IV pressure ulcers.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interventional STIMULAN VG STIMULAN VG Ulcer bursectomy and debridement and STIMULAN VG insertion into the ulcer cavity. Flap closure. Peri-operative antibiotics. Interventional STIMULAN VG Standard of Care Ulcer bursectomy and debridement and STIMULAN VG insertion into the ulcer cavity. Flap closure. Peri-operative antibiotics. Standard of Care (SoC) Standard of Care Ulcer bursectomy, debridement and flap closure. Peri-operative antibiotics.
- Primary Outcome Measures
Name Time Method Individual patient success and findings at the 8 week follow-up visit 8 week An individual patient treatment will be considered a success if there is complete wound closure and healing at the surgical site at two consecutive visits 2 weeks apart.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
NYU Langone Hospital - Long Island Clinical Research Center
🇺🇸Mineola, New York, United States