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

Wounds and Injuries Clinical Trial

Official title:

A Phase I/II Clinical Trial To Determine Safety And Feasibility Of Using An Acellular Amniotic Fluid Application To Expedite Healing In Chronic Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04438174
• Other study ID #: 128708
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 29, 2022
• Est. completion date: March 20, 2023

Study information

• Verified date: August 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective randomized controlled study to determine the safety and feasibility of using processed amniotic fluid (pAF) to expedite healing in chronic wounds.

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. These wounds must have been unresponsive to other therapies, such as debridement, novel topical dressings, moist dressing, off-loading, and edema control, and the wound size must be greater than 5cm2 and less than 75 cm2. We will exclude anyone that has a thermal-related injury (burn or frostbite, etc.) or wounds over joints, requires skin grafting, or wounds with sinus tracts. Our primary objectives are to determine the safety and feasibility of using pAF to treat patients with chronic wounds by determining a reduction in wound size after application of pAF compared to standard of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: March 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Patients 18-85 years old.

2. Patients with chronic lower extremity wounds 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. Patients who have failed previous traditional therapies (such as: standard of care, hyperbaric oxygen therapy, debridement, moist dressings, off-loading and edema control).

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. Patients with thermal-related injuries, such as burns or frostbite or wounds over joints.

6. Patient with sinus tracts, enterocutaneous fistulas or other epithelialized tracts.

7. Patients who require skin grafting.

8. Patients diagnosed with a highly disruptive, non-controlled mental health disorder (e.g.., bipolar, or schizophrenia.

9. Patients with a history of prior drug abuse.

Related Conditions & MeSH terms

• Wounds and Injuries

Intervention

Drug:
• Processed Amniotic Fluid
Injection of 1 ml of processed amniotic fluid per 5 cm2 of wound area

Other:
• Standard of Care Wound Treatment Regimen
ointment-based dressing and non-ointment-based dressings

Locations

Country	Name	City	State
United States	University of Utah Burn Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. Unresolved AE's will be monitored for 1 year.	Up to 1 year after the last study visit.
Secondary	Feasibility - reduction in wound size	The percent reduction in wound area at Visit 5 (final visit) relative to the size at randomization visit. Wound surface area will be calculated and maximal wound depth will also be measured using ImageJ overlay software technology.	Up to 8 months