Back to resultsProcessed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds
Primary Purpose
Wounds and Injuries
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Processed Amniotic Fluid
Standard of Care Wound Treatment Regimen
Sponsored by
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
Arm Type
Experimental
Active Comparator
Arm Label
Amniotic Fluid Injection
Standard of Care Wound Treatment Regimen
Arm Description
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.
Outcomes
Primary Outcome Measures
Safety - adverse events including serious adverse events
Safety and tolerability will be evaluated by the PI from the results of reported signs and symptoms and scheduled physical examinations. Unresolved AE's will be monitored for 1 year.
Secondary Outcome Measures
Feasibility - reduction in wound size
The percent reduction in wound area at Visit 5 (final visit) relative to the size at randomization visit. Wound surface area will be calculated and maximal wound depth will also be measured using ImageJ overlay software technology.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04438174
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 29, 2022 (Actual)
Primary Completion Date
March 20, 2023 (Actual)
Study Completion Date
March 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries
Keywords
chronic wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amniotic Fluid Injection
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care Wound Treatment Regimen
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Processed Amniotic Fluid
Other Intervention Name(s)
Processed Amniotic Fluids (pAF), Human Amniotic Fluids (hAF)
Intervention Description
Injection of 1 ml of processed amniotic fluid per 5 cm2 of wound area
Intervention Type
Other
Intervention Name(s)
Standard of Care Wound Treatment Regimen
Intervention Description
ointment-based dressing and non-ointment-based dressings
Primary Outcome Measure Information:
Title
Safety - adverse events including serious adverse events
Description
Safety and tolerability will be evaluated by the PI from the results of reported signs and symptoms and scheduled physical examinations. Unresolved AE's will be monitored for 1 year.
Time Frame
Up to 1 year after the last study visit.
Secondary Outcome Measure Information:
Title
Feasibility - reduction in wound size
Description
The percent reduction in wound area at Visit 5 (final visit) relative to the size at randomization visit. Wound surface area will be calculated and maximal wound depth will also be measured using ImageJ overlay software technology.
Time Frame
Up to 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giavonni Lewis, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Burn Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds
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