Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Wounds and Injuries
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Masking Description: Wound digital images will be assessed and evaluated by a University Staff member blinded to both the control and treatment group.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 85 years
Gender
Both males and females

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. Th...

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.

Tracking Information

NCT #
NCT04438174
Collaborators
Not Provided
Investigators
Principal Investigator: Giavonni Lewis, MD University of Utah