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.

NCT Number	NCT06283979
Lead Sponsor	Biocomposites Ltd Collaborators: MCRA
Conditions	Pressure Ulcer, Stage IV, Osteomyelitis
Enrollment	60 participants
Start Date	2025-06-15
Primary Completion	2026-12-01 (estimated)
Study Completion	2026-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-06