Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
5 participants
INTERVENTIONAL
2021-06-02
2024-11-18
Brief Summary
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Potentially eligible patients will be pre-screened in clinic. The pre-screening process will include a medical history, including review of co-morbid medical problems and home medications, and a physical exam of the wounds.
The first stage of the study will involve a surgery in which the pyoderma gangrenosum wounds are going to be treated with the EpiFix. About a week later, the patient will then undergo another surgery where skin grafts will be placed on the wounds that were treated in the first surgery. In each surgery, samples of the wound will be taken, and genetic information from these samples will be studied to identify the genes that are active before and after treating the wound with EpiFix.
Routine post-surgery clinic visits will then be used to monitor the healing of the wounds and make sure that no extra medical treatment is needed. Study staff will evaluate wounds twice a week for the first two weeks, then once a week until 6 weeks. Following this, you will then be followed every 4 weeks up to 22 weeks. These visits to the clinic will include taking wound measurements, taking digital photos, asking about level of pain and evaluating development of infection. Patient consent will be obtained to take any photos.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
Patient's pyoderma gangrenosum wounds are treated surgically with EpiFix (dehydrated human amnion/chorion membrane). In another surgery about one week later, we will be covering the treated wounds with split-thickness skin grafts. During each surgery, we will be collecting wound samples for genetic analysis. Routine post-surgery clinic visits will be used to monitor wound healing over a 6-month period.
Dehydrated human amnion/chorion membrane
Dehydrated human amnion/chorion membrane (dHACM) has been commercially available for nearly 15 years. dHACM has been shown to elute growth factors including platelet-derived growth factors, fibroblast growth factors (PDGF), fibroblast growth factors (FGF), transforming growth factor beta 1 (TGF-β1), epidermal growth factor (EGF), vascular endothelial growth factor (VEGF), and placental growth factor (PlGF). Additionally, dHACM exerts immunomodulatory effects by releasing anti-inflammatory interleukins and factors which help regulate the matrix metalloproteinase (MMP) activity. Furthermore, dHACM has also been shown to stimulate mesenchymal stem cell migration and recruitment. dHACM is routinely utilized in the management of chronic wounds including diabetic ulcer and venous ulcers.
Interventions
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Dehydrated human amnion/chorion membrane
Dehydrated human amnion/chorion membrane (dHACM) has been commercially available for nearly 15 years. dHACM has been shown to elute growth factors including platelet-derived growth factors, fibroblast growth factors (PDGF), fibroblast growth factors (FGF), transforming growth factor beta 1 (TGF-β1), epidermal growth factor (EGF), vascular endothelial growth factor (VEGF), and placental growth factor (PlGF). Additionally, dHACM exerts immunomodulatory effects by releasing anti-inflammatory interleukins and factors which help regulate the matrix metalloproteinase (MMP) activity. Furthermore, dHACM has also been shown to stimulate mesenchymal stem cell migration and recruitment. dHACM is routinely utilized in the management of chronic wounds including diabetic ulcer and venous ulcers.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients over 18 years of age
Exclusion Criteria
* patients less than 18 years of age
18 Years
ALL
No
Sponsors
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Louisiana State University Health Sciences Center in New Orleans
OTHER
Responsible Party
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Alison A. Smith
Assistant Clinical Professor of Surgery
Principal Investigators
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Alison Smith, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Louisiana State University Health Sciences Center - New Orleans
Locations
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LSU Healthcare Network Clinic
Metairie, Louisiana, United States
University Medical Center
New Orleans, Louisiana, United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States
Countries
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References
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Maverakis E, Marzano AV, Le ST, Callen JP, Bruggen MC, Guenova E, Dissemond J, Shinkai K, Langan SM. Pyoderma gangrenosum. Nat Rev Dis Primers. 2020 Oct 8;6(1):81. doi: 10.1038/s41572-020-0213-x.
Koob TJ, Rennert R, Zabek N, Massee M, Lim JJ, Temenoff JS, Li WW, Gurtner G. Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J. 2013 Oct;10(5):493-500. doi: 10.1111/iwj.12140. Epub 2013 Aug 1.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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EpiFix Information
Other Identifiers
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IRB: #1579
Identifier Type: -
Identifier Source: org_study_id
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