Actively Recruiting
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 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
N/A
Total Duration
On this page
Sponsors
B
Biocomposites Ltd
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial focuses on patients with stage IV pressure ulcers complicated by osteomyelitis. It aims to evaluate the safety, tolerability, and the difference in effects between a new treatment called STIMULAN VG combined with debridement and systemic antibiotics, versus the standard care involving debridement and systemic antibiotics alone. The study is a phase II, open-label, randomized, multi-center trial designed to compare these approaches in treating this condition. Participants are randomly assigned to one of two groups: one receives ulcer bursectomy, debridement, insertion of STIMULAN VG into the ulcer cavity, followed by flap or primary closure and peri-operative antibiotics; the other group receives the standard care consisting of ulcer bursectomy, debridement, flap or primary closure, and peri-operative antibiotics without STIMULAN VG. The trial evaluates treatment over an 8-week period post-operation. During the study, participants will undergo assessments to determine individual patient success and clinical outcomes at the 8-week follow-up visit. Researchers will monitor safety and tolerability throughout the trial, with evaluations including imaging to confirm osteomyelitis and clinical status related to wound healing. Participants are expected to comply with scheduled visits, treatment plans, and study procedures for the duration of the trial.
CONDITIONS
Brief 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...
- Presenting with a Stage IV pressure ulcer requiring excision, bony debridement, and flap coverage or primary closure
- Candidate for flap surgery or primary closure
- Evidence of focal osteomyelitis shown by MRI or CT scan
- Adults aged 18 years or older at treatment
- Able to comply fully with the study protocol and attend scheduled visits
- Able to provide voluntary signed informed consent
You will not qualify if you...
- Causes of pressure ulcer that cannot be addressed
- Severe immunological compromise
- Widespread pelvic osteomyelitis not suitable for adequate debridement
- Presence of head pressure ulcers
- Active substance abuse within last 2 years that may affect safety or recovery
- Current smoker
- Diabetes with HbA1C above 9
- Allergy to components of the investigational product (calcium sulfate, Vancomycin, Gentamicin)
- Participation in another investigational product study
- Pregnant or planning pregnancy during study
- Flexion contractures preventing full leg extension
- Uncontrolled muscle spasms
- Unable to follow bedrest or offloading requirements
- Unable to provide consent
- Fecal or urinary incontinence contaminating the wound
- Vascularly compromised lower extremity pressure ulcers as defined by specific blood flow measurements
- Clinically malnourished as judged by investigator
- Conditions causing or risking high blood calcium levels
- Investigator deems participation unsafe or may compromise trial results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week or until surgery and immediate recovery
Participants receive ulcer bursectomy, debridement, and flap or primary closure surgery. Those in the experimental group have STIMULAN VG inserted into the ulcer cavity along with peri-operative antibiotics.
1 surgery and peri-operative care visit
Duration - 8 weeks
Participants are monitored for healing and treatment success after surgery, including an 8-week follow-up to assess individual patient outcomes.
1 follow-up visit at 8 weeks
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
D
Daniel Roberts
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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