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Clinical Trial Summary

A prospective randomized controlled study to determine the safety and feasibility of using processed amniotic fluid (pAF) to expedite healing in chronic wounds.


Clinical Trial Description

The goal of our study is to assess, in an outpatient setting, the safety and the time to wound closure in chronic wounds treated with processed amniotic fluid (pAF). We will include patients with lower extremity full thickness wounds that are greater than 3 months old and less than 12 months old. The wound size must be greater than 5cm2 and less than 75 cm2. We will exclude anyone that requires skin grafting, or wounds with sinus tracts. Our primary objective is to determine the safety and feasibility of using pAF to treat patients with chronic wounds. The secondary objective is to determine the efficacy of pAF compared to standard of care in reducing wound area. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04438174
Study type Interventional
Source University of Utah
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date August 2022
Completion date March 2023

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