Actively Recruiting
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.
Led by Biocomposites Ltd · Updated on 2026-05-06
60
Participants Needed
9
Research Sites
76 weeks
Total Duration
On this page
Sponsors
B
Biocomposites Ltd
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a Stage IV pressure ulcer needing excision, bony debridement, and flap coverage or primary closure
- Be a candidate for flap surgery or primary closure
- Have focal osteomyelitis shown by MRI or CT scan
- Be 18 years of age or older at treatment
- Be mentally, physically, and psychosocially able to follow the study plan
- Provide voluntary signed informed consent before any study procedures
You will not qualify if you...
- Causes of the pressure ulcer cannot be addressed
- Severely immunocompromised as determined by a clinician
- Have diffuse or widespread pelvic osteomyelitis not suitable for adequate debridement
- Have head pressure ulcers
- History of active substance abuse in the last 2 years that may affect safety or recovery
- Current smoker
- Diabetic with Hba1C above 9
- Allergy to any component of the investigational product like calcium sulfate or certain antibiotics
- Currently in another investigational product study
- Pregnant or planning pregnancy during the study
- Flexion contractures preventing full passive extension
- Uncontrolled muscle spasms
- Unable to comply with bedrest or offloading requirements
- Unable to provide consent
- Fecal or urinary incontinence contaminating the wound
- Lower extremity pressure ulcer with vascular compromise defined by specific index or pressure thresholds
- Clinically malnourished as judged by investigator
- Conditions with known or high risk for hypercalcemia
- Investigator believes participation risks safety or trial results
- Patients with vascularly compromised lower extremity ulcers may be rescreened after successful revascularization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Advanced Foot Care, LLC
Phoenix, Arizona, United States, 85032
Actively Recruiting
2
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
3
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
4
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
5
Missouri Orthopaedic Institute
Columbia, Missouri, United States, 65201
Actively Recruiting
6
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
7
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07103
Actively Recruiting
8
NYU Langone Hospital - Long Island Clinical Research Center
Mineola, New York, United States, 11501
Actively Recruiting
9
University of Pittsburgh, McGowan Institute for Regenerative Medicine
Pittsburgh, Pennsylvania, United States, 15219
Actively Recruiting
Research Team
K
Keira Watts, Clinical Research Director
CONTACT
D
Daniel Roberts
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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