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A Multicenter, Prospective, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of Venous Leg Ulcers (VALUE)

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Trial Profile

A Multicenter, Prospective, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of Venous Leg Ulcers (VALUE)

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Aug 2024

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At a glance

  • Drugs EscharEx (Primary)
  • Indications Leg ulcer; Varicose ulcer; Wounds
  • Focus Adverse reactions; Registrational
  • Acronyms VALUE
  • Sponsors MediWound
  • Most Recent Events

    • 26 Aug 2024 Status changed from planning to not yet recruiting.
    • 29 May 2024 According to a MediWound media release, Phase III trial remains on track for final protocol submission in the first half of 2024. The global study aims to enroll 216 patients across 40 sites to be treated with either EscharEx or a gel vehicle placebo. An interim assessment will be performed once 67% of participants complete the trial. The study is expected to commence in the second half of 2024.
    • 25 Apr 2024 According to a MediWound media release, design of the upcoming Phase III study in venous leg ulcers (VLU) will be presented at the 2024 Symposium on Advanced Wound Care (SAWC), Orlando, Florida.

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