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.
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Biocomposites Ltd
- Study ID
- NCT06283979
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Osteomyelitis
- Pressure Ulcer, Stage IV
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- STIMULAN VG — COMBINATION_PRODUCTInsertion of STIMULAN VG into the ulcer cavity prior to flap/primary closure.
- Standard of Care — PROCEDUREStandard of Care. Ulcer bursectomy, debridement and flap/primary closure. Peri-operative antibiotics.
Study Details
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.
Key Dates
- Start date
- Jun 15, 2025
- Status verified
- Oct 2025
- Primary completion
- Dec 1, 2026
- Completion
- Dec 1, 2026
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Interventional STIMULAN VGUlcer bursectomy and debridement and STIMULAN VG insertion into the ulcer cavity. Flap/primary closure. Peri-operative antibiotics.
- Active Comparator: Standard of Care (SoC)Ulcer bursectomy, debridement and flap/primary closure. Peri-operative antibiotics.
Primary Outcome Measure
Individual patient success and findings at the 8 week follow-up visit [ Time Frame: 8 week ]
Central Contacts
- Keira Watts, Clinical Research Director+44 (0) 1782 338 580
- Daniel Roberts
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Advanced Foot Care, LLC | Phoenix | Arizona | 85032 | Jaminelli Banks, DPM (PRINCIPAL_INVESTIGATOR) |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | Robert Galiano, MD (PRINCIPAL_INVESTIGATOR) |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Dan Molitor Sarah Meehan Aamir Siddiqui, MD (PRINCIPAL_INVESTIGATOR) |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | Venkata Seerapu Laxmi Dhungel Ian Hoppe, MD (PRINCIPAL_INVESTIGATOR) |
| Missouri Orthopaedic Institute | Columbia | Missouri | 65201 | Andrew Monhollen Vicki Jones Brett Crist, MD (PRINCIPAL_INVESTIGATOR) |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | Katie Ostlund Gabriel Gauthier James Willcockson, MD (PRINCIPAL_INVESTIGATOR) |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | Saharsh Patel Mehreen Bhatti Alex Wong, MD, FACS (PRINCIPAL_INVESTIGATOR) |
| NYU Langone Hospital - Long Island Clinical Research Center | Mineola | New York | 11501 | Scott Gorenstein, MD (PRINCIPAL_INVESTIGATOR) |
| University of Pittsburgh, McGowan Institute for Regenerative Medicine | Pittsburgh | Pennsylvania | 15219 | Sashwati Roy, PhD, MS (PRINCIPAL_INVESTIGATOR) |
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