Diabetic Foot Ulcers Clinical Trial
Official title:
An Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up (PMCF) Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU, When Using Mepilex Transfer Ag as Intended
An open, non-comparative, multi-centre post marketing clinical follow-up, PMCF, investigation to evaluate performance and safety on diabetic foot ulcer, dfu, when using mepilex transfer Ag as intended.
Approximately 25-30 subjects from two to three centers will be evaluated provided they
fulfill the inclusion criteria and none of the exclusion criteria and gives a signed and
dated consent.
Subjects to be included were to suffer from a DFU and being in need of anti-microbial wound
dressing.
Dressing changes were to performed according to the local clinical routine (usually 3
times/week), evaluated during a total treatment period of maximum 4 weeks including weekly
visits when assessments were being done. A record (dressing log) for Mepilex Transfer Ag and
outer layers were to be filled in at every dressing change.
Photos taken directly upon dressing removal and after cleansing /debridement were to be
collected to visually follow the ulcers status.
At each visit the investigators/nurse and subjects opinion (using an evaluation form) were to
be asked for questions considering the use of Mepilex Transfer Ag. Pain before, during and
after removal will be assessed.
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