Status:
TERMINATED
Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds
Lead Sponsor:
University of Utah
Conditions:
Wounds and Injuries
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief Summary
A prospective randomized controlled study to determine the safety and feasibility of using processed amniotic fluid (pAF) to expedite healing in chronic wounds.
Detailed 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 lowe...
Eligibility Criteria
Inclusion
- Patients 18-85 years old.
- Patients with chronic lower extremity wounds (including thermal) 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.
- Patient who is able to complete required site study visits and procedures in good faith
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04438174
Start Date
August 1 2022
End Date
March 1 2023
Last Update
June 7 2024
Active Locations (1)
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1
University of Utah Burn Center
Salt Lake City, Utah, United States, 84132