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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
Patients with full thickness wounds
Patients with chronic lower extremity wounds that are greater than 3 months, but less than 12 months 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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have wounds that go all the way through your skin.
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You have a wound on your leg that has been there for more than 3 months, but less than a year.
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You have a wound that is larger than 5 square centimeters but smaller than 75 square centimeters.
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You have already tried and not benefited from common treatments like standard care, oxygen therapy, wound cleaning, bandages, reducing pressure on the affected area, and controlling swelling.

Timeline

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

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,088 Previous Clinical Trials
1,728,348 Total Patients Enrolled
10 Trials studying Wounds and Injuries
4,561 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
~0 spots leftby Mar 2025