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Processed Amniotic Fluid for Wounds and Injuries

Phase 1 & 2

Waitlist Available

Led By Giavonni Lewis, MD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year after the last study visit.

Awards & highlights

Study Summary

This trial looks at whether using processed amniotic fluid can help healing chronic wounds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year after the last study visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year after the last study visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after the last study visit. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety - adverse events including serious adverse events

Secondary outcome measures

Feasibility - reduction in wound size

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Amniotic Fluid InjectionExperimental Treatment1 Intervention

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.

Group II: Standard of Care Wound Treatment RegimenActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Processed Amniotic Fluid

2022

Completed Phase 2

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,103 Previous Clinical Trials

1,781,716 Total Patients Enrolled

11 Trials studying Wounds and Injuries

7,561 Patients Enrolled for Wounds and Injuries

Giavonni Lewis, MDPrincipal InvestigatorUniversity of Utah

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is access to this trial available for participants at present?

"According to clinicaltrials.gov, this current medical study is still enrolling participants since it was last updated on November 7th 2022, after being initially posted on September 29th2022."

Answered by AI

Does the age requirement for this research project cap at thirty years old?

"The trial's eligibility criteria state that participants must be between the ages of 18 and 85 in order to enroll."

Answered by AI

What is the maximum capacity of individuals that can take part in this research?

"Indeed, according to the information posted on clinicaltrials.gov, this medical trial is still enrolling participants as of November 7th 2022. It was initially launched on September 29th, and requires 60 individuals from one particular site for completion."

Answered by AI

Is it feasible for me to become a participant in this clinical study?

"This medical trial is seeking 60 participants aged 18 to 85 who have full thickness chronic wounds, ranging in size from 5 cm2 to 75 cm2. These individuals must also have undergone traditional treatments such as standard of care, hyperbaric oxygen therapy, debridement and edema control without success."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Giavonni Lewis 2022. "Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04438174.