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NCT05539963 · ClinicalTrials.gov registry record · Phase 2
A Feasibility Trial to Investigate the Safety and Between-group Effect Size of STIMULAN VG and Standard of Care (SoC) in Participants With Diabetic Foot Osteomyelitis
A Phase 2 study of Diabetic Foot Osteomyelitis, sponsored by Biocomposites.
- Active
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 10
- Study locations
NCT05539963: Active Phase 2 study of Diabetic Foot Osteomyelitis, sponsored by Biocomposites.
NCT05539963 is a Phase 2 study of Diabetic Foot Osteomyelitis that is active but no longer recruiting, run by Biocomposites. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05539963, a Phase 2 study of Diabetic Foot Osteomyelitis, is active but no longer recruiting, sponsored by Biocomposites.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 10
- Study locations
Study Summary
The purpose of this trial is to evaluate the safety and between-group effect size of STIMULAN VG compared to SoC treatment in patients with diabetic foot osteomyelitis (DFO).
Primary Outcome
Confirmed absence of clinical signs of osteomyelitis or surgical site infection at the index site will be evidenced by Negative Probe to Bone Test (PTB), absence of draining sinus presumed to be from underlying bone and MRI scan at Week 24.
Conditions Studied
Interventions
- DRUG STIMULAN VG
- DRUG Systemic Antibiotics
Study Locations (10)
Arizona
- Titan Clinical Research - Mesa
- Axsendo Clinical Research - Phoenix
- Perseverance Research Center, LLC - Scottsdale
- Advanced Footcare LLC - Scottsdale
North Carolina
- UNC School Medicine - Chapel Hill
- Seaside Clinical Research Institute - Wilmington
Arkansas
- NEA Baptist Clinic - Jonesboro
Nevada
- Viable Clinical Research - Henderson
New Jersey
- Equitable Health Partners - NJ - Mountainside
New York
- Mount Sinai West - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2023-01-23 |
| Est. Completion | 2025-12-30 |
| Phase | Phase 2 |
What the registry record for NCT05539963 still lists
NCT05539963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Diabetic Foot Osteomyelitis appearing as the primary indexed condition, and to 2 interventions - of which STIMULAN VG is the first listed.
NCT05539963 lists 10 locations in 6 states (Arizona, North Carolina, Arkansas).
Frequently Asked Questions
What is clinical trial NCT05539963 about?
NCT05539963 is a clinical study titled "A Feasibility Trial to Investigate the Safety and Between-group Effect Size of STIMULAN VG and Standard of Care (SoC) in Participants With Diabetic Foot Osteomyelitis". The purpose of this trial is to evaluate the safety and between-group effect size of STIMULAN VG compared to SoC treatment in patients with diabetic foot osteomyelitis (DFO).
What is the current status of trial NCT05539963?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2023-01-23. Estimated completion is 2025-12-30.
What conditions does trial NCT05539963 study?
This clinical trial studies the following conditions: Diabetic Foot Osteomyelitis.
What interventions are being tested in trial NCT05539963?
The interventions under investigation include: STIMULAN VG (DRUG), Systemic Antibiotics (DRUG).
Who is sponsoring clinical trial NCT05539963?
This trial is sponsored by Biocomposites, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05539963 being conducted?
This trial has 10 study locations across Arizona, Arkansas, Nevada, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05539963's enrollment target sits among peer trials
61 1026th of 2000 higher than 974 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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