Effectiveness of Aurix Therapy in Pressure Ulcers (NCT02352467) | Clinical Trial Compass
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Effectiveness of Aurix Therapy in Pressure Ulcers
United States800 participantsStarted 2015-02
Plain-language summary
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard care and compared 1:1 to patients receiving undefined Usual and Customary Care.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Medicare eligible
✓. ≥18 years of age
✓. Ulcer of pressure/shear etiology (Stage II, III, and IV, see Appendix 9 for stage definitions)
✓. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located on the heel, ischium, sacrum, and trochanter
✓. For subjects with potentially multiple eligible PUs, the largest ulcer will be selected as the Index Ulcer for study. There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)
✓. Debrided ulcer size between 3 cm2 and 200 cm2
✓. Subject has received UCC care for ≥ 2 weeks at treating wound clinic