Trial Outcomes & Findings for Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds (NCT NCT04438174)

Last Updated: 2024-06-07

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Approximately 7 months after enrollment

Results posted on

2024-06-07

Participant Flow

Participant milestones

Participant milestones
Measure	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. Processed Amniotic Fluid: 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. Standard of Care Wound Treatment Regimen: ointment-based dressing and non-ointment-based dressings
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Amniotic Fluid Injection n=1 Participants 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. Processed Amniotic Fluid: 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. Standard of Care Wound Treatment Regimen: ointment-based dressing and non-ointment-based dressings	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	1 participants n=93 Participants	—	1 participants n=27 Participants

PRIMARY outcome

Timeframe: Approximately 7 months after enrollment

Population: Enrollment was halted prematurely after enrolling one participant due to difficulty finding eligible participants.

Outcome measures

Outcome measures
Measure	Amniotic Fluid Injection n=1 Participants 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. Processed Amniotic Fluid: 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. Standard of Care Wound Treatment Regimen: ointment-based dressing and non-ointment-based dressings
Safety - Adverse Events Including Serious Adverse Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Visit 2 (approximately 6 weeks after enrollment) and Visit 5 (approximately 7 months after enrollment)

Population: Enrollment was halted prematurely after enrolling one participant due to difficulty finding eligible participants.

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.

Outcome measures

Outcome measures
Measure	Amniotic Fluid Injection n=1 Participants 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. Processed Amniotic Fluid: 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. Standard of Care Wound Treatment Regimen: ointment-based dressing and non-ointment-based dressings
Feasibility - Reduction in Wound Size - Secondary Outcome Per Secondary Assessor	91.4 percent reduction in wound area Interval 91.4 to 91.4	—

SECONDARY outcome

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

Population: Enrollment was halted prematurely after enrolling one participant due to difficulty finding eligible participants.

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.

Outcome measures

Outcome measures
Measure	Amniotic Fluid Injection n=1 Participants 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. Processed Amniotic Fluid: 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. Standard of Care Wound Treatment Regimen: ointment-based dressing and non-ointment-based dressings
Feasibility - Reduction in Wound Size - Secondary Outcome Per Primary Assessor	-33.7 percent reduction in wound area Interval -33.7 to -33.7	—

Adverse Events

Amniotic Fluid Injection

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard of Care Wound Treatment Regimen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Amniotic Fluid Injection n=1 participants at risk 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. Processed Amniotic Fluid: 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. Standard of Care Wound Treatment Regimen: ointment-based dressing and non-ointment-based dressings
Infections and infestations Wound Infection	100.0% 1/1 • Number of events 1 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.	— 0/0 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.

Other adverse events

Other adverse events
Measure	Amniotic Fluid Injection n=1 participants at risk 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. Processed Amniotic Fluid: 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. Standard of Care Wound Treatment Regimen: ointment-based dressing and non-ointment-based dressings
Surgical and medical procedures Wound drainage	100.0% 1/1 • Number of events 1 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.	— 0/0 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.
Investigations Gram stain positive	100.0% 1/1 • Number of events 1 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.	— 0/0 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.
Vascular disorders Haemorrhage	100.0% 1/1 • Number of events 1 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.	— 0/0 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.
Skin and subcutaneous tissue disorders Erythema	100.0% 1/1 • Number of events 1 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.	— 0/0 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.
Skin and subcutaneous tissue disorders Rash	100.0% 1/1 • Number of events 1 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.	— 0/0 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.
General disorders Ulcer	100.0% 1/1 • Number of events 1 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.	— 0/0 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.
General disorders Malaise	100.0% 1/1 • Number of events 1 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.	— 0/0 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.
Injury, poisoning and procedural complications Wound complication	100.0% 1/1 • Number of events 1 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.	— 0/0 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.
Blood and lymphatic system disorders Increased tendency to bruise	100.0% 1/1 • Number of events 1 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.	— 0/0 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.
General disorders Oedema peripheral	100.0% 1/1 • Number of events 1 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.	— 0/0 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.
Skin and subcutaneous tissue disorders Rash macular	100.0% 1/1 • Number of events 1 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.	— 0/0 • For purposes of this study, events that occur following participant consent through visit 5 (approximately 7 months after enrollment) will be reported as adverse events. Adverse events were on the schedule of activities for collection at visits 2 through 5 (approximately 7 months after enrollment). Subjects were to receive a follow-up phone call within 24 hours AND 5-7 days after visit 2 and 3 to identify any adverse events that occur in relation to study participation and record additional medications that were taken.

Additional Information

Dr. Giavonni Lewis

University of Utah

Phone: 801-581-3050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place