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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.

Study acronym: BLADE OPU2
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study sites: 8 to 9v13
  2. Study sites: 7 to 8v12
  3. Study sites: 6 to 7v11
  4. Study sites: 5 to 6v10
  5. Study sites: 4 to 5v9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary and study completion dates: Dec 1, 2025 to Dec 1, 2026
    • Study sites: 1 to 4
    v8
  2. Start date: May 15, 2025 to Jun 15, 2025v7
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 15, 2025 to May 15, 2025
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 45 words
    v6
  4. Primary completion date: Dec 1, 2024 to Dec 1, 2025
    • Start date: Sep 1, 2024 to Feb 15, 2025
    v5
  5. Start date: Jul 1, 2024 to Sep 1, 2024v4
  6. Start date: Apr 1, 2024 to Jul 1, 2024v3
  7. Study title shortened, about 10 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06283979
Lead Sponsor Biocomposites Ltd
Collaborators: MCRA
Conditions
(from sponsor)		 Pressure Ulcer, Stage IV, Osteomyelitis
Related terms Osteomyelitis, Pressure Ulcer
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov