Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds
Wounds and Injuries
About this trial
This is an interventional treatment trial for Wounds and Injuries focused on measuring chronic wounds
Eligibility Criteria
Inclusion Criteria:
- Patients 18-85 years old.
- Patients with chronic lower extremity wounds that are greater than 3 months, but less than 12 months old.
- Patients with full thickness wounds.
- Patients with at least one wound that is ≥5 cm2 and<75 cm2 in size.
- Patients who have failed previous traditional therapies (such as: standard of care, hyperbaric oxygen therapy, debridement, moist dressings, off-loading and edema control).
Exclusion Criteria:
- Patients admitted to the hospital at the time of enrollment.
- Patients who are pregnant, nursing or plan to become pregnant while participating in the study. If of child-bearing potential, unwillingness to use effective birth control while participating in the study.
- Suspicion of or diagnosis of osteomyelitis underlying the wound.
- Patients who have received an investigational agent or intervention within the prior 30 days or plan to use within the study period.
- Patients with thermal-related injuries, such as burns or frostbite or wounds over joints.
- Patient with sinus tracts, enterocutaneous fistulas or other epithelialized tracts.
- Patients who require skin grafting.
- Patients diagnosed with a highly disruptive, non-controlled mental health disorder (e.g.., bipolar, or schizophrenia.
- Patients with a history of prior drug abuse.
Sites / Locations
- University of Utah Burn Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Amniotic Fluid Injection
Standard of Care Wound Treatment Regimen
Processed Amniotic Fluid. Dose is 1ml/5cm2; Route: injected directly into wound; Limited to two injections. The wound will then be dressed according to standard of care.
Primary dressings are variable and based on the moisture content and microorganism load. In general, wounds respond differently to various topical treatments. Through our clinical practice, we have found that wounds plateau with the same topical for greater than 4 weeks, hence changing antimicrobial topical helps to manage the bacterial overgrowth. We will start with our application of our slurry, a 1:1:1 ratio of Nystatin ointment, Mupirocin Ointment, and Bacitracin Ointment. This slurry will be applied directly to the cleansed wound, followed by silver gauze/foam product to all wounds. Types of silver product- site and comfort predict use of Restore, Mepilex-AG, or Mepitel-AG. If allergies to the above slurry occurs, we will use medical honey with or without bacitracin. If ointment related rash present with transition to silver product only or silver product plus medical honey.