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Enrollment was halted prematurely after enrolling one participant due to difficulty finding eligible participants.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Processed Amniotic Fluid | Drug | Injection of 1 ml of processed amniotic fluid per 5 cm2 of wound area |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giavonni Lewis, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Burn Center | Salt Lake City | Utah | 84132 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Enrollment was halted prematurely after enrolling one subject.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age at randomization |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Enrollment was halted prematurely after enrolling one participant due to difficulty finding eligible participants. | Posted | Count of Participants | Participants | Approximately 7 months after enrollment |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound Infection | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound drainage | Surgical and medical procedures | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Giavonni Lewis | University of Utah | 801-581-3050 | giavonni.lewis@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2022 | Nov 22, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2021 | Nov 29, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 8, 2022 | Jan 23, 2024 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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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).
| Standard of Care Wound Treatment Regimen | Other | ointment-based dressing and non-ointment-based dressings |
|
| 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. | Visit 2 (approximately six weeks after enrollment) and Visit 5 (approximately 7 months after enrollment) |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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 |
| OG001 | 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 |
|
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| 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. | Enrollment was halted prematurely after enrolling one participant due to difficulty finding eligible participants. | Posted | Mean | Full Range | percent reduction in wound area | Visit 2 (approximately 6 weeks after enrollment) and Visit 5 (approximately 7 months after enrollment) |
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| 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. | Enrollment was halted prematurely after enrolling one participant due to difficulty finding eligible participants. | Posted | Mean | Full Range | percent reduction in wound area | Visit 2 (approximately six weeks after enrollment) and Visit 5 (approximately 7 months after enrollment) |
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| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| Gram stain positive | Investigations | Systematic Assessment |
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| Haemorrhage | Vascular disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Ulcer | General disorders | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
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| Wound complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Increased tendency to bruise | Blood and lymphatic system disorders | Systematic Assessment |
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| Oedema peripheral | General disorders | Systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | Systematic Assessment |
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