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A Feasibility Trial to Investigate the Safety and Between-group Effect Size of STIMULAN VG and Standard of Care (SoC) in Participants With Diabetic Foot Osteomyelitis

Study acronym: BLADE-VG2
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 60 to confirmed 61
    • Site details revised at 10 of 10 sites
    v16
  2. Primary completion date: May 30, 2025 to Jun 20, 2025v15
  3. Study sites: 8 to 10
    • Primary completion date: Apr 30, 2025 to May 30, 2025
    v14
  4. Study sites: 7 to 8v13
  5. Primary completion date: Dec 30, 2024 to Apr 30, 2025v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 6 to 7v11
  2. Study sites: 3 to 6v10
  3. Primary completion date: Jun 30, 2024 to Dec 30, 2024v9 Show 4 more changesShow less
    • Study completion date: Jun 30, 2025 to Dec 30, 2025
    • Eligibility criteria shortened, about 18 words
    • Site details revised at 1 of 3 sites
    • Study title shortened, about 3 words
  4. Study sites revised (3)v8
  5. Primary completion date: Dec 1, 2023 to Jun 30, 2024v7 Show 9 more changesShow less
    • Primary endpoints: 4 to 3
    • Study completion date: Jun 1, 2024 to Jun 30, 2025
    • Interventions: Stimulan-VG (Drug), Systemic Antibiotics (Drug) to STIMULAN VG (Drug), Systemic Antibiotics (Drug)
    • Eligibility criteria expanded, about 46 words
    • Secondary endpoints: details revised at 2 of 10 entries
    • Site details revised at 1 of 3 sites
    • Collaborator revised
    • Study description expanded, about 1 word
    • Study title expanded, about 1 word
  6. Study sites: 2 to 3v6
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Jan 11, 2023 to Jan 23, 2023
    v5
  8. Start date: Nov 23, 2022 to Jan 11, 2023v4
  9. Start date: Oct 20, 2022 to Nov 23, 2022v3
  10. Secondary endpoints: details revised at 1 of 10 entriesv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 evaluate the safety and between-group effect size of STIMULAN VG compared to SoC treatment in patients with diabetic foot osteomyelitis (DFO).
Trial Details
NCT Number NCT05539963
Lead Sponsor Biocomposites Ltd
Collaborators: MCRA
Conditions
(from sponsor)		 Diabetic Foot Osteomyelitis
Enrollment 61 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov