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Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy

Study acronym: DIANE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 1 to 2 Collaborators: 2 to 3v3 Show 1 more changeShow less
    • Collaborators: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 15, 2024 to Jan 2, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Dec 15, 2024 to Jan 2, 2025
    • Site details revised
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this study is to learn if the clinical effects of Negative Pressure Wound Therapy (NPWT) is better, worse or the same as standard wound care for patients with diabetic foot ulcers (DFUs). The main questions it aims to answer are: * Will there be a difference in the number of major amputations between the groups during the first year? * Will one of the treatments require more surgeries and longer hospital stays? All participants will: * be treated with NPWT or standard wound care for their diabetic foot ulcer after surgery * be followed closely at the out-patient clinic for one year after treatment
Trial Details
NCT Number NCT06721754
Lead Sponsor University Hospital, Akershus
Collaborators: South-Eastern Norway Regional Health Authority, University of Oslo, Ostfold Hospital Trust
Conditions Diabetic Foot Ulcer
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov