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.
NCT ID: NCT06283979
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-06-15
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interventional STIMULAN VG
Ulcer bursectomy and debridement and STIMULAN VG insertion into the ulcer cavity.
Flap/primary closure. Peri-operative antibiotics.
STIMULAN VG
Insertion of STIMULAN VG into the ulcer cavity prior to flap/primary closure.
Standard of Care
Standard of Care. Ulcer bursectomy, debridement and flap/primary closure. Peri-operative antibiotics.
Standard of Care (SoC)
Ulcer bursectomy, debridement and flap/primary closure. Peri-operative antibiotics.
Standard of Care
Standard of Care. Ulcer bursectomy, debridement and flap/primary closure. Peri-operative antibiotics.
Interventions
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STIMULAN VG
Insertion of STIMULAN VG into the ulcer cavity prior to flap/primary closure.
Standard of Care
Standard of Care. Ulcer bursectomy, debridement and flap/primary closure. Peri-operative antibiotics.
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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MCRA
INDUSTRY
Biocomposites Ltd
INDUSTRY
Responsible Party
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Locations
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Advanced Foot Care, LLC
Phoenix, Arizona, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Missouri Orthopaedic Institute
Columbia, Missouri, United States
NYU Langone Hospital - Long Island Clinical Research Center
Mineola, New York, United States
University of Pittsburgh, McGowan Institute for Regenerative Medicine
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Keira Watts, Clinical Research Director
Role: CONTACT
Phone: +44 (0) 1782 338 580
Email: [email protected]
Facility Contacts
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Kanchan Veranandani
Role: primary
Rajashekhar Ittedi
Role: backup
Brigid Coles
Role: primary
Tarifa Adam
Role: backup
Andrew Monhollen
Role: primary
Vicki Jones
Role: backup
Anita Farha
Role: primary
Monica Benitez
Role: backup
Urmila Gnyawali
Role: primary
Scot King
Role: backup
Other Identifiers
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199723
Identifier Type: -
Identifier Source: org_study_id