Wounds and Injuries
Conditions
Keywords
chronic wounds
Brief summary
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.
Interventions
DRUGProcessed Amniotic Fluid
Injection of 1 ml of processed amniotic fluid per 5 cm2 of wound area
OTHERStandard of Care Wound Treatment Regimen
ointment-based dressing and non-ointment-based dressings
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Adverse Events Including Serious Adverse Events | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Reduction in Wound Size - Secondary Outcome Per Secondary Assessor | Visit 2 (approximately 6 weeks after enrollment) and Visit 5 (approximately 7 months after enrollment) | 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. |
| Feasibility - Reduction in Wound Size - Secondary Outcome Per Primary Assessor | Visit 2 (approximately six weeks after enrollment) and Visit 5 (approximately 7 months after enrollment) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1 |
| 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 |
| Total | 1 |
Baseline characteristics
| Characteristic | Amniotic Fluid Injection | Standard of Care Wound Treatment Regimen | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 1 participants | — | 1 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 1 / 1 | 0 / 0 |
| serious Total, serious adverse events | 1 / 1 | 0 / 0 |
Outcome results
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).
Time frame: Approximately 7 months after enrollment
Population: Enrollment was halted prematurely after enrolling one participant due to difficulty finding eligible participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Amniotic Fluid Injection | Safety - Adverse Events Including Serious Adverse Events | 0 Participants |
| Standard of Care Wound Treatment Regimen | Safety - Adverse Events Including Serious Adverse Events | 0 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Amniotic Fluid Injection | Feasibility - Reduction in Wound Size - Secondary Outcome Per Primary Assessor | -33.7 percent reduction in wound area |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Amniotic Fluid Injection | Feasibility - Reduction in Wound Size - Secondary Outcome Per Secondary Assessor | 91.4 percent reduction in wound area |