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.

Phase 2

Recruiting

• Conditions: Osteomyelitis; Pressure Ulcer, Stage IV

• Registration Number: NCT06283979
• Lead Sponsor: Biocomposites Ltd

Brief 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.

Detailed Description

The trial is an open-label, multi-center, randomized (1:1), controlled phase 2 trial in patients diagnosed with stage IV pressure ulcers.

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-28
• Study Start: 2025-06-15
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-07
• Last Update Posted: 2025-10-08
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Individual patient success and findings at the 8 week follow-up visit	8 week	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.

Trial Locations

Locations (4)

Advanced Foot Care, LLC; 🇺🇸 Phoenix, Arizona, United States

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

NYU Langone Hospital - Long Island Clinical Research Center; 🇺🇸 Mineola, New York, United States

University of Pittsburgh, McGowan Institute for Regenerative Medicine; 🇺🇸 Pittsburgh, Pennsylvania, United States