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: Terminated

Administrative data

• NCT number: NCT04438174
• Other study ID #: 128708
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: August 2022
• Est. completion date: March 2023

Study information

• Verified date: May 2024
• 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2023
• Est. primary completion date: March 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 (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.

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. 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	Feasibility - Reduction in Wound Size - Secondary Outcome Per Secondary Assessor	The percent reduction in wound area at Visit 5 (final visit) relative to the size at randomization visit (visit 2). Wound surface area will be calculated and maximal wound depth will also be measured using ImageJ overlay software technology. Two assessors examined the wound surface area at each visit using ImageJ. This is the outcome as reported by the secondary assessor. A negative value indicates an increase in wound size; a positive value indicates a decrease in wound size.	Visit 2 (approximately 6 weeks after enrollment) and Visit 5 (approximately 7 months after enrollment)
Secondary	Feasibility - Reduction in Wound Size - Secondary Outcome Per Primary Assessor	The percent reduction in wound area at Visit 5 (final visit) relative to the size at randomization visit (visit 2). Wound surface area will be calculated and maximal wound depth will also be measured using ImageJ overlay software technology. Two assessors examined the wound surface area at each visit using ImageJ. This is the outcome as reported by the primary assessor. A negative value indicates an increase in wound size; a positive value indicates a decrease in wound size.	Visit 2 (approximately six weeks after enrollment) and Visit 5 (approximately 7 months after enrollment)