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.

ClinicalTrials.gov ID: NCT06283979

Public ClinicalTrials.gov record NCT06283979. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 11, 2026, 5:18 PM EDT

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Official title

A Multi-center, Randomized (1:1), Controlled Phase II Trial of STIMULAN VG With Debridement and a Course of Systemic Antibiotics vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06283979
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Biocomposites Ltd; Industry
Enrollment: 60 participants

Conditions and interventions

Conditions

Interventions

STIMULAN VG Combination Product
Standard of Care Procedure

Combination Product · Procedure

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 14, 2025
Primary completion: Nov 30, 2026
Completion: Nov 30, 2026
Last update posted: May 5, 2026

2025 – 2026

United States locations

U.S. sites: 9
U.S. states: 9
U.S. cities: 9

Facility	City	State	ZIP	Site status
Advanced Foot Care, LLC	Phoenix	Arizona	85032	Recruiting
Northwestern University Feinberg School of Medicine	Chicago	Illinois	60611	Recruiting
Henry Ford Hospital	Detroit	Michigan	48202	Recruiting
University of Mississippi Medical Center	Jackson	Mississippi	39216	Recruiting
Missouri Orthopaedic Institute	Columbia	Missouri	65201	Recruiting
University of Nebraska Medical Center	Omaha	Nebraska	68198	Recruiting
Rutgers New Jersey Medical School	Newark	New Jersey	07103	Recruiting
NYU Langone Hospital - Long Island Clinical Research Center	Mineola	New York	11501	Recruiting
University of Pittsburgh, McGowan Institute for Regenerative Medicine	Pittsburgh	Pennsylvania	15219	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06283979, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 5, 2026 · Synced Sep 11, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06283979 live on ClinicalTrials.gov.

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