ConvaNiox in treatment of diabetes foot ulcers

  • Research type

    Research Study

  • Full title

    A prospective, multi-centre, observational, real world evidence study on the efficacy and safety of a Nitric Oxide Generating Dressing (ConvaNiox™) in the treatment of diabetes related foot ulcers (DFUs).

  • IRAS ID

    368263

  • Contact name

    Matthew Mal

  • Contact email

    matthew.malone@convatec.com

  • Clinicaltrials.gov Identifier

    NCT07438951

  • Duration of Study in the UK

    0 years, 9 months, 1 days

  • Research summary

    Hard-to-heal wounds are defined as wounds that do not transition through the normal phases of healing in a timely manner. Hard-to-heal wounds are associated with a significant reduction in health related quality of life and place a great burden on healthcare professionals and healthcare systems. Despite recent advances in wound care, the number of hard-to-heal wounds is rising. One of the most prevalent hard-to-heal wounds are diabetes related foot ulcers (DFUs). This study will proactively collect and evaluate real world evidence (RWE) on the safety and performance of a nitric oxide generating dressing (ConvaNiox™) post-market launch, in the treatment of DFUs. For the purpose of this study, we will refer to the nitric oxide generating dressing (ConvaNiox™) as EDX110. Eligible participants will be over the age of 18, with a diagnosis of type 1 or type 2 diabetes, with a non-healing DFU.

  • REC name

    London - City & East Research Ethics Committee

  • REC reference

    26/PR/0322

  • Date of REC Opinion

    1 May 2026

  • REC opinion

    Further Information Favourable Opinion