Wounds and InjuriesPhase 1/2NCT04438174
Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds
A Phase 1/2 study testing Processed Amniotic Fluid in people with Wounds and Injuries, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Processed Amniotic Fluid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2022to Mar 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18-85 years old.
- Patients with chronic lower extremity wounds (including thermal) that are greater than 3 months, but less than 12 months old.
- Patients with full thickness wounds.
- Patients with at least one wound that is ≥5 cm2 and<75 cm2 in size.
- Patient who is able to complete required site study visits and procedures in good faith
Who cannot join
- Patients admitted to the hospital at the time of enrollment.
- 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.
- Suspicion of or diagnosis of osteomyelitis underlying the wound.
- Patients who have received an investigational agent or intervention within the prior 30 days or plan to use within the study period.
- Patient with sinus tracts, enterocutaneous fistulas or other epithelialized tracts.
- Patients who require skin grafting.
- Patients diagnosed with a highly disruptive, non-controlled mental health disorder (e.g.., bipolar, or schizophrenia.
- Patients with a history of prior drug abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Burn Center
Salt Lake City, Utah, 84132
About this study
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
A prospective randomized controlled study to determine the safety and feasibility of using processed amniotic fluid (pAF) to expedite healing in chronic wounds.
Read the detailed 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.
- Conditions
- Wounds and Injuries
- Being tested
- Processed Amniotic Fluid, Standard of Care Wound Treatment Regimen
- Keywords
- chronic wounds
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Processed Amniotic FluidDrug
Also called Processed Amniotic Fluids (pAF), Human Amniotic Fluids (hAF)
Injection of 1 ml of processed amniotic fluid per 5 cm2 of wound area
Standard of Care Wound Treatment RegimenOther
ointment-based dressing and non-ointment-based dressings
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Processed Amniotic Fluid |
| 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. Receives: Other: Standard of Care Wound Treatment Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Approximately 7 months after enrollment
Secondary outcomes (2)
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.
Measured: 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.
Measured: Visit 2 (approximately six weeks after enrollment) and Visit 5 (approximately 7 months after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study startAug 2022
- Primary completionMar 2023
- Study completionMar 2023
Why it stopped: Enrollment was halted prematurely after enrolling one participant due to difficulty finding eligible participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giavonni Lewis, University of Utah
- Investigators
- Giavonni Lewis, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438174
- Sponsor's protocol ID
- 128708
- Status last verified
- May 2024
- First submitted
- 16 Jun 2020
- Last updated
- 7 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04438174
- Acronym / sponsor ID
- 128708
- Conditions
- Wounds and Injuries
- Keywords
- chronic wounds
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was halted prematurely after enrolling one participant due to difficulty finding eligible participants.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Aug 2022 (actual)
- Primary completion
- Mar 2023 (actual)
- Study completion
- Mar 2023 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Posted 7 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective randomized controlled study to determine the safety and feasibility of using processed amniotic fluid (pAF) to expedite healing in chronic wounds.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amniotic Fluid Injection | Experimental | Drug: Processed Amniotic FluidProcessed 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 | Other: Standard of Care Wound Treatment RegimenPrimary 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients 18-85 years old.
- Patients with chronic lower extremity wounds (including thermal) that are greater than 3 months, but less than 12 months old.
- Patients with full thickness wounds.
- Patients with at least one wound that is ≥5 cm2 and<75 cm2 in size.
- Patient who is able to complete required site study visits and procedures in good faith
Key exclusion criteria (8 listed)
- Patients admitted to the hospital at the time of enrollment.
- 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.
- Suspicion of or diagnosis of osteomyelitis underlying the wound.
- Patients who have received an investigational agent or intervention within the prior 30 days or plan to use within the study period.
- Patient with sinus tracts, enterocutaneous fistulas or other epithelialized tracts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Processed Amniotic FluidAlso: Processed Amniotic Fluids (pAF), Human Amniotic Fluids (hAF)Injection of 1 ml of processed amniotic fluid per 5 cm2 of wound area | Drug | Amniotic Fluid Injection |
| Standard of Care Wound Treatment Regimenointment-based dressing and non-ointment-based dressings | Other | Standard of Care Wound Treatment Regimen |
Primary outcome
Safety - Adverse Events Including Serious Adverse Events
Time frame: Approximately 7 months after enrollment
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).
2 secondary outcomes
Feasibility - Reduction in Wound Size - Secondary Outcome Per Secondary Assessor
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
Time frame: Visit 2 (approximately six weeks after enrollment) and Visit 5 (approximately 7 months after enrollment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giavonni Lewis, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Processed Amniotic Fluid in people with Wounds and Injuries, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Adverse Events Including Serious Adverse Events (time frame: Approximately 7 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.