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

NCT ID: NCT04438174

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2023-03-31

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. 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.

Conditions

Wounds and Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Processed Amniotic Fluid

Intervention Type: DRUG

Injection of 1 ml of processed amniotic fluid per 5 cm2 of wound area

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care Wound Treatment Regimen

Intervention Type: OTHER

ointment-based dressing and non-ointment-based dressings

Interventions

Processed Amniotic Fluid

Injection of 1 ml of processed amniotic fluid per 5 cm2 of wound area

Intervention Type: DRUG

Standard of Care Wound Treatment Regimen

ointment-based dressing and non-ointment-based dressings

Intervention Type: OTHER

Other Intervention Names

Processed Amniotic Fluids (pAF); Human Amniotic Fluids (hAF)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Giavonni Lewis

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giavonni Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah Burn Center

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

128708

Identifier Type: -

Identifier Source: org_study_id