Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin

  • STATUS
    None
  • participants needed
    212
  • sponsor
    Molnlycke Health Care AB
Updated on 4 November 2020
Universit tsklinikum Erlangen (8.7 mi away) Contact
aquacel

Summary

The investigation is designed as an open, randomized, non-inferiority, multi-centre investigation.

212 evaluable subjects will be randomised. Subjects to be included will suffer from an exuding venous or mixed ulcer of predominantly venous origin. Subjects will either be randomized to Exufiber or Aquacel Extra using centralized randomization

Description

Visits are planned for baseline followed by 1, 2, 3, 4 and 6 weeks post treatment. The sub-group of at least 50 subjects will also be followed at week 8, 12, 16, 20, and 24 post treatment or until wound is healed if earlier.

Details
Treatment Aquacel Extra, Exufiber
Clinical Study IdentifierNCT02921750
SponsorMolnlycke Health Care AB
Last Modified on4 November 2020

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