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

NCT04438174 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 128708
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds and Injuries

Keywords

chronic wounds

Outcome Measures

Primary Outcomes (1)

• Safety - Adverse Events Including Serious Adverse Events

  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 Outcomes (2)

• Feasibility - Reduction in Wound Size - Secondary Outcome Per Secondary Assessor

  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

  Visit 2 (approximately six weeks after enrollment) and Visit 5 (approximately 7 months after enrollment)

Study Arms (2)

Amniotic Fluid Injection

EXPERIMENTAL

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

Standard of Care Wound Treatment Regimen

ACTIVE COMPARATOR

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

Interventions

Processed Amniotic Fluid DRUG

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

Also known as: Processed Amniotic Fluids (pAF), Human Amniotic Fluids (hAF)

Amniotic Fluid Injection

Standard of Care Wound Treatment Regimen OTHER

ointment-based dressing and non-ointment-based dressings

Standard of Care Wound Treatment Regimen

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18-85 years old.
• Patients with chronic lower extremity wounds (including thermal) 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.
• Patient who is able to complete required site study visits and procedures in good faith

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Burn Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Limitations and Caveats

Enrollment was halted prematurely after successful enrollment of one participant due to limited eligible participants. A single participant was enrolled in the treatment arm, hence we are unable to measure the safety and effectiveness of the intervention compared to standard care. We noted variation in wound size assessment for our single participant.

Results Point of Contact

• Title: Dr. Giavonni Lewis
• Organization: University of Utah

giavonni.lewis@hsc.utah.edu

801-581-3050

Study Officials

• Giavonni Lewis, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Wound digital images will be assessed and evaluated by two University Staff members blinded to both the control and treatment group (one primary and one secondary).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: August 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: June 7, 2024
• Results First Posted: June 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)