A Phase 1/2 interventional study of Processed Amniotic Fluid and Standard of Care Wound Treatment Regimen in Wounds and Injuries, sponsored by University of Utah. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-06-07.
Sponsored by University of Utah · Phase 1/2, Interventional, and Treatment
A prospective randomized controlled study to determine the safety and feasibility of using processed amniotic fluid (pAF) to expedite healing in chronic wounds.
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 1 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
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Exclusion Criteria:
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
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
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)
ointment-based dressing and non-ointment-based dressings
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).
Time frame: Approximately 7 months after enrollment
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.
Time frame: 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
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.
Time frame: Visit 2 (approximately six weeks after enrollment) and Visit 5 (approximately 7 months after enrollment)
| Milestone | Amniotic Fluid Injection | Standard of Care Wound Treatment Regimen |
|---|---|---|
| Started | 1 | 0 |
| Completed | 1 | 0 |
| Not completed | 0 | 0 |
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).
| Participants | Amniotic Fluid Injection | Standard of Care Wound Treatment Regimen |
|---|---|---|
| Safety - Adverse Events Including Serious Adverse Events | 0 | 0 |
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.
| percent reduction in wound area | Amniotic Fluid Injection | Standard of Care Wound Treatment Regimen |
|---|---|---|
| Feasibility - Reduction in Wound Size - Secondary Outcome Per Secondary Assessor | 91.4 (91.4 to 91.4) | — |
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.
| percent reduction in wound area | Amniotic Fluid Injection | Standard of Care Wound Treatment Regimen |
|---|---|---|
| Feasibility - Reduction in Wound Size - Secondary Outcome Per Primary Assessor | -33.7 (-33.7 to -33.7) | — |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Amniotic Fluid Injection | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| Standard of Care Wound Treatment Regimen | — | — | — |
| Event | Amniotic Fluid Injection | Standard of Care Wound Treatment Regimen |
|---|---|---|
| Wound InfectionInfections and infestations | 1/1 | — |
| Event | Amniotic Fluid Injection | Standard of Care Wound Treatment Regimen |
|---|---|---|
| Wound drainageSurgical and medical procedures | 1/1 | — |
| Gram stain positiveInvestigations | 1/1 | — |
| HaemorrhageVascular disorders | 1/1 | — |
| ErythemaSkin and subcutaneous tissue disorders | 1/1 | — |
| RashSkin and subcutaneous tissue disorders | 1/1 | — |
| UlcerGeneral disorders | 1/1 | — |
| MalaiseGeneral disorders | 1/1 | — |
| Wound complicationInjury, poisoning and procedural complications | 1/1 | — |
| Increased tendency to bruiseBlood and lymphatic system disorders | 1/1 | — |
| Oedema peripheralGeneral disorders | 1/1 | — |
Enrollment was halted prematurely after enrolling one subject.
| Age, Categorical(Participants) | Amniotic Fluid Injection | Standard of Care Wound Treatment Regimen | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | Amniotic Fluid Injection | Standard of Care Wound Treatment Regimen | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Amniotic Fluid Injection | Standard of Care Wound Treatment Regimen | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Amniotic Fluid Injection | Standard of Care Wound Treatment Regimen | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 0 | 1 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Amniotic Fluid Injection | Standard of Care Wound Treatment Regimen | Total |
|---|---|---|---|
| United States | 1 | — | 1 |
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University of Utah