Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds

Status Completed

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. These wounds must have been unresponsive to other therapies, such as debridement, novel topical dressings, moist dressing, off-loading, and edema control, and the wound size must be greater than 5cm2 and less than 75 cm2. We will exclude anyone that has a thermal-related injury (burn or frostbite, etc.) or wounds over joints, requires skin grafting, or wounds with sinus tracts. Our primary objectives are to determine the safety and feasibility of using pAF to treat patients with chronic wounds by determining a reduction in wound size after application of pAF compared to standard of care. ;

Study Design

Related Conditions & MeSH terms

Wounds and Injuries

Clinical Trial Details

NCT number	NCT04438174
Study type	Interventional
Source	University of Utah
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	September 29, 2022
Completion date	March 20, 2023

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