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.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiocomposites Ltd

About this trial

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 criteria

Qualifiers

Presenting with a Stage IV pressure ulcer requiring treatment of excision, bony debridement and flap coverage/primary closure.

Operative candidate for flap surgery or primary closure.

Presence of focal osteomyelitis as suggested by imaging to show extent of infection. Acceptable imaging techniques are Magnetic Resonance Imaging or CT scan.

Adults ≥ 18 years in age at the time of treatment.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • STIMULAN VG
  • Standard of Care

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

9
Arizona
Advanced Foot Care, LLC85032, Phoenix United States
Illinois
Northwestern University Feinberg School of Medicine60611, Chicago United States
Michigan
Henry Ford Hospital48202, Detroit United States
Mississippi
University of Mississippi Medical Center39216, Jackson United States

Sponsors and collaborators

Biocomposites Ltd

Lead sponsor

MCRA

Collaborator