Pressure Ulcer Clinical Trial
Official title:
Clinical Trial to Evaluate Efficacy and Safety of Ultrasonic Surgical Device (ULSC-12D)in Chronic Pressure Ulcer
Study objective The purpose of this trial is to evaluate the efficacy and safety of the investigational device, ULSD-12D, as Compared to the comparator, SONOCA-180, in chronic wound.
- Study design Multi-center, randomized clinical trial
- Study population Adults with chronic wound
- Investigational device treatment procedure Before Treatment: The subject's eligibility
(inclusion/exclusion criteria) will be assessed,and apply the Study Device or
Comparator on their wound in a randomized manner. Post-Treatment: All subjects will
take pictures of the wound area and measured the number of microorganism and wound
size.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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