Comparing STIMULAN VG to standard care for treating severe pressure ulcers with infection

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.

This study is testing if a new treatment called STIMULAN VG, used with surgery and antibiotics, can help adults with severe pressure ulcers and infections heal better than standard care alone.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Biocomposites Ltd (Industry-sponsored)
• Locations: 9 sites (Phoenix, Arizona and 8 other locations)
• Trial ID: NCT06283979 on ClinicalTrials.gov

What this trial studies

This trial evaluates the safety and effectiveness of STIMULAN VG combined with surgical debridement and systemic antibiotics against standard care, which includes debridement and antibiotics alone, for patients with stage IV pressure ulcers complicated by osteomyelitis. It is an open-label, multi-center, randomized controlled phase II trial, enrolling adults who require surgical intervention for their ulcers. The study aims to determine the between-group effect size and tolerability of the new treatment approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with stage IV pressure ulcers requiring surgical treatment and evidence of focal osteomyelitis.

Not a fit: Patients with pressure ulcers not requiring surgical intervention or those with contraindications to flap surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve healing outcomes for patients with severe pressure ulcers and associated infections.

How similar studies have performed: Other studies have explored similar interventions, but the specific combination of STIMULAN VG with standard care in this context is relatively novel.

Eligibility criteria

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, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
6. Ability of the subject or legal authorized representative to provide voluntary, signed and dated informed consent prior to any study-related procedures.

Subjects who meet any of the following criteria will be excluded from participating in this study:

1. Reasons contributing to pressure ulcer cannot be addressed.
2. Severe immunological compromised patients as determined by the clinician.
3. Patients with diffuse or widespread pelvic osteomyelitis that is not amenable to adequate margins for debridement.
4. Patients presenting with head pressure ulcers.
5. Current or recent history (within last 2 years) of active substance abuse (e.g., recreational drugs, narcotics, or alcohol) that in the judgement of the investigator, may compromise the participant's safety/recovery or ability to follow the trial procedures.
6. Current smoker.
7. Diabetic patient with Hba1C level above 9.
8. Allergy to any component of the investigational product, such as calcium sulfate, glycopeptide antibiotics (Vancomycin), or aminoglycoside antibiotics (Gentamicin).
9. Concurrent involvement in a study of another investigational product.
10. Pregnant or planning to become pregnant during study period.
11. Flexion contractures where patient cannot passively get full extension.
12. Uncontrolled muscle spasms.
13. Unable to comply with bedrest restriction or offloading requirements
14. Unable to provide consent.
15. Fecal or urinary incontinence with contamination of the wound.
16. Lower extremity pressure ulcer location that is vascularly compromised as defined by an Ankle Brachial Index ≤ 0.7 mm Hg OR toe brachial index ≤ 0.6 mm OR toe pressure ≤ 40 mm Hg OR transcutaneous oximetry ≤ 40 mm Hg \*
17. Investigator considers the participant to be clinically malnourished.
18. Any conditions with known hypercalcemia (\> 10.3 mg/dl) or posing a significant risk for developing hypercalcemia (i.e., Hyperparathyroidism).
19. Investigator believes trial participation may compromise safety of the participant or trial results.

    * Patients presenting with lower extremity pressure ulcers that are vascularly compromised can be rescreened followed successful revascularization

Where this trial is running

Phoenix, Arizona and 8 other locations

• Advanced Foot Care, LLC — Phoenix, Arizona, United States (Recruiting)
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States (Recruiting)
• Henry Ford Hospital — Detroit, Michigan, United States (Recruiting)
• University of Mississippi Medical Center — Jackson, Mississippi, United States (Recruiting)
• Missouri Orthopaedic Institute — Columbia, Missouri, United States (Recruiting)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
• Rutgers New Jersey Medical School — Newark, New Jersey, United States (Recruiting)
• NYU Langone Hospital - Long Island Clinical Research Center — Mineola, New York, United States (Recruiting)
• University of Pittsburgh, McGowan Institute for Regenerative Medicine — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Keira Watts, Clinical Research Director

Conditions Pressure Ulcer, Stage IV; Osteomyelitis; between-group effect size; surgical debridement; ulcer bursectomy; systemic antibiotics