Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06283979 · ClinicalTrials.gov registry record · Phase 2
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.
A Phase 2 study of Osteomyelitis and Pressure Ulcer, Stage IV, sponsored by Biocomposites.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 7
- Study locations
NCT06283979: Recruiting Phase 2 study of Osteomyelitis and Pressure Ulcer, Stage IV, sponsored by Biocomposites.
NCT06283979 is a Phase 2 study of Osteomyelitis and Pressure Ulcer, Stage IV that is actively recruiting participants, run by Biocomposites. The registered enrollment target is 60 participants, below the 308-participant average among 4 other Osteomyelitis trials with a reported enrollment target (81% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06283979, a Phase 2 study of Osteomyelitis and Pressure Ulcer, Stage IV, is actively recruiting participants, sponsored by Biocomposites.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 7
- Study locations
Study Summary
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.
Primary Outcome
An individual patient treatment will be considered a success if there is complete wound closure and healing at the surgical site at two consecutive visits 2 weeks apart.
Conditions Studied
Interventions
- PROCEDURE Standard of Care
- COMBINATION_PRODUCT STIMULAN VG
Study Locations (7)
Arizona
- Advanced Foot Care, LLC - Phoenix
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
Mississippi
- University of Mississippi Medical Center - Jackson
Missouri
- Missouri Orthopaedic Institute - Columbia
Nebraska
- University of Nebraska Medical Center - Omaha
New York
- NYU Langone Hospital - Long Island Clinical Research Center - Mineola
Pennsylvania
- University of Pittsburgh, McGowan Institute for Regenerative Medicine - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-06-15 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 2 |
What NCT06283979 shows while recruiting
NCT06283979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 308-participant average among 4 other Osteomyelitis trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Osteomyelitis appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT06283979 lists 7 locations in 7 states (Arizona, Illinois, Mississippi).
Frequently Asked Questions
What is clinical trial NCT06283979 about?
NCT06283979 is a clinical study titled "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.". 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.
What is the current status of trial NCT06283979?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-06-15. Estimated completion is 2026-12-01.
What conditions does trial NCT06283979 study?
This clinical trial studies the following conditions: Osteomyelitis, Pressure Ulcer, Stage IV.
What interventions are being tested in trial NCT06283979?
The interventions under investigation include: Standard of Care (PROCEDURE), STIMULAN VG (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06283979?
This trial is sponsored by Biocomposites, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06283979 being conducted?
This trial has 7 study locations across Arizona, Illinois, Mississippi, Missouri, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteomyelitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Retention and Re-Engagement in Treatment for Addiction Following Serious Injection Related Infections (RETAIN)
RECRUITING · NA
-
Quasi-Randomized Evaluation of the UCLA Next Day Clinic (NDC)
ACTIVE NOT RECRUITING · NA
-
UT Southwestern Diabetic Foot Ulcers (DFU) and Osteomyelitis (DFO) Recruitment Database, Data and Tissue Repository
COMPLETED
-
Dalbavancin For The Treatment of Gram Positive Osteoarticular Infections
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI