- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04438174
Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds
August 15, 2023 updated by: Giavonni Lewis, University of Utah
A Phase I/II Clinical Trial To Determine Safety And Feasibility Of Using An Acellular Amniotic Fluid Application To Expedite Healing In Chronic Wounds
A prospective randomized controlled study to determine the safety and feasibility of using processed amniotic fluid (pAF) to expedite healing in chronic wounds.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84132
- University of Utah Burn Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Amniotic Fluid Injection
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.
|
Injection of 1 ml of processed amniotic fluid per 5 cm2 of wound area
Other Names:
|
Active Comparator: Standard of Care Wound Treatment Regimen
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.
|
ointment-based dressing and non-ointment-based dressings
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety - adverse events including serious adverse events
Time Frame: Up to 1 year after the last study visit.
|
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.
|
Up to 1 year after the last study visit.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility - reduction in wound size
Time Frame: Up to 8 months
|
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.
|
Up to 8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Giavonni Lewis, MD, University of Utah
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 29, 2022
Primary Completion (Actual)
March 20, 2023
Study Completion (Actual)
March 20, 2023
Study Registration Dates
First Submitted
June 16, 2020
First Submitted That Met QC Criteria
June 16, 2020
First Posted (Actual)
June 18, 2020
Study Record Updates
Last Update Posted (Actual)
August 18, 2023
Last Update Submitted That Met QC Criteria
August 15, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 128708
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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