Clinical trial NCT04438174: Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds
Official title: A Phase I/II Clinical Trial To Determine Safety And Feasibility Of Using An Acellular Amniotic Fluid Application To Expedite Healing In Chronic Wounds
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Wounds and Injuries
Keywords: chronic wounds
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 lower extremity full thickness wounds that are greater than 3 months old and less than 12 months old. The wound size must be greater than 5cm2 and less than 75 cm2. We will exclude anyone that requires skin grafting, or wounds with sinus tracts. Our primary objective is to determine the safety and feasibility of using pAF to treat patients with chronic wounds. The secondary objective is to determine the efficacy of pAF compared to standard of care in reducing wound area.

Eligibility criteria: Inclusion Criteria:

1. Patients 18-85 years old.
2. Patients with chronic lower extremity wounds (including thermal) 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. Patient who is able to complete required site study visits and procedures in good faith

Exclusion Criteria:

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. Patient with sinus tracts, enterocutaneous fistulas or other epithelialized tracts.
6. Patients who require skin grafting.
7. Patients diagnosed with a highly disruptive, non-controlled mental health disorder (e.g.., bipolar, or schizophrenia.
8. Patients with a history of prior drug abuse.

Primary outcomes:
measure: Safety - Adverse Events Including Serious Adverse Events
timeFrame: Approximately 7 months after enrollment
Secondary outcomes:
measure: Feasibility - Reduction in Wound Size - Secondary Outcome Per Secondary Assessor
timeFrame: Visit 2 (approximately 6 weeks after enrollment) and Visit 5 (approximately 7 months after enrollment)
measure: Feasibility - Reduction in Wound Size - Secondary Outcome Per Primary Assessor
timeFrame: Visit 2 (approximately six weeks after enrollment) and Visit 5 (approximately 7 months after enrollment)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Burn Center
state: Utah
Study officials:
affiliation: University of Utah
name: Giavonni Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References: