Wounds Clinical Trial
Official title:
A Prospective, Randomized, Controlled Study of the Efficacy of Sharp Debridement for the Management of Chronic Wounds
Standard care of care and up to twelve (12) weekly debridements. Subjects randomized into the weekly debridement group will receive up to twelve (12) debridement during the twelve (12) weeks of the study. There will be two (2) subject groups in the study. Subjects will be randomized into either the monthly debridement group or the weekly debridement group.
The primary objective of this study is to evaluate subjects enrolled and randomized to the
weekly sharp debridement group.
The major secondary objectives are incidence of complete wound closure at Week 12, rate of
healing, ulcer recurrence, wound characteristics, and microbiologic information.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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