Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds

May 9, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Processed Amniotic Fluid
Injection of 1 ml of processed amniotic fluid per 5 cm2 of wound area
Other Names:
  • Processed Amniotic Fluids (pAF)
  • Human Amniotic Fluids (hAF)
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.
Other: Standard of Care Wound Treatment Regimen
ointment-based dressing and non-ointment-based dressings

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety - Adverse Events Including Serious Adverse Events
Time Frame: Approximately 7 months after enrollment
Safety and tolerability will be evaluated by the PI from the results of reported signs and symptoms and scheduled physical examinations. The primary endpoint is whether the patient experienced any post-randomization, study-related serious adverse event (SAEs) while on study (collections of new AEs begins at visit two and ends at visit five which is approximately, 7 months after enrollment). An SAE is considered study-related if the medical monitor concludes the SAE is either possibly related or probably related to study participation. Although unresolved SAE's were to be monitored for 1 year or until resolution, no SAEs were unresolved at the time of study completion (approximately, 7 months after enrollment).
Approximately 7 months after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility - Reduction in Wound Size - Secondary Outcome Per Secondary Assessor
Time Frame: Visit 2 (approximately 6 weeks after enrollment) and Visit 5 (approximately 7 months after enrollment)
The percent reduction in wound area at Visit 5 (final visit) relative to the size at randomization visit (visit 2). Wound surface area will be calculated and maximal wound depth will also be measured using ImageJ overlay software technology. Two assessors examined the wound surface area at each visit using ImageJ. This is the outcome as reported by the secondary assessor. A negative value indicates an increase in wound size; a positive value indicates a decrease in wound size.
Visit 2 (approximately 6 weeks after enrollment) and Visit 5 (approximately 7 months after enrollment)
Feasibility - Reduction in Wound Size - Secondary Outcome Per Primary Assessor
Time Frame: Visit 2 (approximately six weeks after enrollment) and Visit 5 (approximately 7 months after enrollment)
The percent reduction in wound area at Visit 5 (final visit) relative to the size at randomization visit (visit 2). Wound surface area will be calculated and maximal wound depth will also be measured using ImageJ overlay software technology. Two assessors examined the wound surface area at each visit using ImageJ. This is the outcome as reported by the primary assessor. A negative value indicates an increase in wound size; a positive value indicates a decrease in wound size.
Visit 2 (approximately six weeks after enrollment) and Visit 5 (approximately 7 months after enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Wounds and Injuries

Clinical Trials on Processed Amniotic Fluid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings