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A Novel Therapeutic Treatment of Pyoderma Gangrenosum

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ClinicalTrials.gov Identifier: NCT05120726
Recruitment Status : Recruiting
First Posted : November 15, 2021
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
Alison A. Smith, Louisiana State University Health Sciences Center in New Orleans

Brief Summary:

Pyoderma gangrenosum is a chronic debilitating ulcerative neutrophilic condition usually affecting the skin. The pathogenesis of pyoderma gangrenosum is poorly understood. Pyoderma gangrenosum has been estimated to have an incidence rate of 3-10 per million populations per year. Mortality estimates range up to 30%. The non-healing wounds present a significant social and economic burden on affected patients. We hypothesize that EpiFix (dehydrated human amnion/chorion membrane) will be beneficial in treating patients with pyoderma gangrenosum.

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.


Condition or disease Intervention/treatment Phase
Pyoderma Gangrenosum Biological: Dehydrated human amnion/chorion membrane Phase 4

Detailed Description:
In part because of its efficacy, the number of clinical indications for dehydrated human amnion/chorion membrane (dHACM) has expanded, and a number of case reports now suggest pyoderma gangrenosum can be successfully treated with dHACM. However, the mechanisms underlying dHACM's beneficial effects is entirely unstudied. The overall goal of the proposed study is to characterize the transcriptome of a pyoderma gangrenosum wound before and after successful treatment with dHACM. We will identify certain genes or genetic pathways that are specifically targeted by treatment of a wound with dehydrated human amnion/chorion membrane (EpiFix). With this data, we hope to better understand the method by which EpiFix can specifically heal a wound. Ultimately, all this data will be used to identify specific findings that aid in the diagnosis and treatment of pyoderma gangrenosum. A previous IRB-approved study by Dr. Frank Lau at LSU and colleagues (unpublished data) investigated the use of EpiFix to treat wounds in 3 patients with pyoderma gangrenosum with success and minimal complications.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Novel Therapeutic Treatment of Pyoderma Gangrenosum
Actual Study Start Date : June 2, 2021
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Biological: 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 Names:
  • EpiFix
  • dHACM




Primary Outcome Measures :
  1. Gene Measurements [ Time Frame: Wound specimen are collected during each surgical intervention (over ~2 weeks) ]
    Identifying genes or genetic pathways that are specifically targeted by treatment of a wound with dehydrated human amnion/chorion membrane (dHACM)

  2. Wound Size [ Time Frame: ~6 months (post-op weeks 1, 2, 3, 4, 5, 6, 10, 14, 18, 22; +/- 2 weeks each time in case conflicts arise) ]
    Size of the pyoderma wound (mm)


Secondary Outcome Measures :
  1. Infection [ Time Frame: ~6 months (post-op weeks 1, 2, 3, 4, 5, 6, 10, 14, 18, 22; +/- 2 weeks each time in case conflicts arise) ]
    Yes/No

  2. Pain Level [ Time Frame: ~6 months (post-op weeks 1, 2, 3, 4, 5, 6, 10, 14, 18, 22; +/- 2 weeks each time in case conflicts arise) ]
    Scale (0-10) (0 = no pain, 10 = worst pain ever experienced)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients diagnosed with pyoderma gangrenosum
  • patients over 18 years of age

Exclusion Criteria:

  • members of vulnerable populations (pregnant women and prisoners)
  • patients less than 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05120726


Contacts
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Contact: Alison Smith, MD, PhD 504-903-9009 asmi60@lsuhsc.edu

Locations
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United States, Louisiana
LSU Healthcare Network Clinic Recruiting
Metairie, Louisiana, United States, 70006
Contact: Frank Lau, MD    504-412-1240    flau@lsuhsc.edu   
Contact: Alison Smith, MD, PhD    504-903-9009    asmi60@lsuhsc.edu   
Principal Investigator: Alison Smith, MD, PhD         
Sub-Investigator: Frank Lau, MD         
University Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Alison Smith, MD, PhD    504-903-9009    asmi60@lsuhsc.edu   
Contact: Frank Lau, MD    504-412-1240    flau@lsuhsc.edu   
Principal Investigator: Alison Smith, MD, PhD         
Sub-Investigator: Frank Lau, MD         
Ochsner Baptist Medical Center Enrolling by invitation
New Orleans, Louisiana, United States, 70115
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Investigators
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Principal Investigator: Alison Smith, MD, PhD Louisiana State University Health Sciences Center - New Orleans
  Study Documents (Full-Text)

Documents provided by Alison A. Smith, Louisiana State University Health Sciences Center in New Orleans:
Informed Consent Form  [PDF] March 6, 2021

Additional Information:
Publications:
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Responsible Party: Alison A. Smith, Assistant Clinical Professor of Surgery, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT05120726    
Other Study ID Numbers: IRB: #1579
First Posted: November 15, 2021    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Alison A. Smith, Louisiana State University Health Sciences Center in New Orleans:
Pyoderma Gangrenosum
EpiFix
dehydrated human amnion/chorion membrane
Additional relevant MeSH terms:
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Pyoderma
Pyoderma Gangrenosum
Skin Diseases
Skin Diseases, Vascular
Skin Ulcer