Principal Investigator: Giavonni Lewis
Keywords: Acellular Amniotic Fluid , chronic wounds , pAF for chronic wounds Department: Surgery Administration
IRB Number: 00128708
Specialty: Surgery, General
Sub Specialties: Burn Surgery
Recruitment Status: Recruiting

Contact Information

Hina Yazdani
hina.yazdani@hsc.utah.edu
801-587-2506

Brief Summary

This is a prospective randomized controlled study to determine the safety and feasibility of using processed sterile filtered amniotic fluid (pAF) to expedite healing in chronic wounds

The goal of our study is to assess, in an outpatient setting, the safety and healing in chronic wounds treated with 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 or equal to 5cm2 and less than 75 cm2. We will exclude anyone that is admitted to the hospital at the time of enrollment, is less than 18 years old or older than 85 years old, is known to be pregnant or planning to become pregnant (including women of childbearing potential who are unwilling to use effective birth control while participating in the study), is breastfeeding, has suspicion of osteomyelitis, has received or plans to receive an investigational agent or intervention, has a thermal-related injury (burn or frostbite, etc.) or wounds over joints, requires skin grafting, has wounds with sinus tracts, has a diagnosed highly disruptive uncontrolled mental health disorder, or has a known history of prior drug abuse. Our primary objective is to determine the safety of using pAF to treat patients with chronic wounds and our secondary objective is to assess the reduction in wound size after application of pAF compared to standard of care.

OBJECTIVES: 

  • Primary Objective: The Burn Outpatient Clinic sees multiple types of wounds from burn to non-burn.  The care of patients with chronic wounds is complex and difficult.  To date, we have not found any treatments, including various dressings or other stem cell based therapies, which consistently reduce time of wound closure and improve pain. We would like to investigate the safety of using pAF to treat these wounds.
  • Secondary Objective: To determine efficacy by examining a reduction in wound size after application of pAF compared to Standard of Care (SOC)

 

ENDPOINTS: 

  • Primary Endpoint: Whether the patient experienced any post-randomization, study-related SAEs while on study (up to Visit 5, defined later).
  • Secondary Endpoint:  The percent reduction in wound area at Visit 5 relative to the size at randomization visit.

 

The role of the efficacy analysis is de-emphasized, with efficacy only a secondary objective.  We do not claim that the study is adequately powered to demonstrate efficacy; however, it is reasonable to assess efficacy in a phase 2 trial, and then if a phase 3 trial is warranted, adequately power the phase 3 trial.

Inclusion Criteria

Inclusion:

  1. Patients 18-85 years old.
  2. Patients with chronic lower extremity wounds that are greater than 3 months, but less than 12 months old.
  3. Patients with full thickness wounds.
  4. Patients with at least one wound that is ≥5 cm2 and<75 cm2 in size.
  5. Patients who have failed previous traditional therapies (such as: standard of care, hyperbaric oxygen therapy, debridement, moist dressings, off-loading and edema control).

Of note, the subjects in the control arm subjects will be consented as with the treatment arm. 

Exclusion Criteria

Exclusion:

  1. Patients admitted to the hospital at the time of enrollment.
  2. 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.
  3. Suspicion of or diagnosis of osteomyelitis underlying the wound.
  4. Patients who have received an investigational agent or intervention within the prior 30 days or plan to use within the study period.
  5. Patients with thermal-related injuries, such as burns or frostbite or wounds over joints.
  6. Patient with sinus tracts, enterocutaneous fistulas or other epithelialized tracts.
  7. Patients who require skin grafting.
  8. Patients diagnosed with a highly disruptive, non-controlled mental health disorder (e.g.., bipolar, or schizophrenia.
  9. Patients with a history of prior drug abuse.