Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds
Last updated on July 2021Recruitment
- 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