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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 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. The trial reports 10 study locations across 6 states.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05539963
The ClinicalTrials.gov registry entry for NCT05539963 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biocomposites, which has 3 total studies on file at ClinicalTrials.gov.
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 reports 10 study locations spanning 6 distinct geographic areas - top geographies include 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.
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