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.
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.
Biocomposites Ltd
60 participants
Jun 15, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Insertion of STIMULAN VG into the ulcer cavity prior to flap/primary closure.
Standard of Care. Ulcer bursectomy, debridement and flap/primary closure. Peri-operative antibiotics.
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT06283979