Clinical trial NCT05120726: A Novel Therapeutic Treatment of Pyoderma Gangrenosum
Official title: A Novel Therapeutic Treatment of Pyoderma Gangrenosum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pyoderma Gangrenosum
Keywords: Pyoderma Gangrenosum
EpiFix
dehydrated human amnion/chorion membrane
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Gene Measurements
timeFrame: Wound specimen are collected during each surgical intervention (over ~2 weeks)
measure: Wound Size
timeFrame: ~6 months (post-op weeks 1, 2, 3, 4, 5, 6, 10, 14, 18, 22; +/- 2 weeks each time in case conflicts arise)
Secondary outcomes:
measure: Infection
timeFrame: ~6 months (post-op weeks 1, 2, 3, 4, 5, 6, 10, 14, 18, 22; +/- 2 weeks each time in case conflicts arise)
measure: Pain Level
timeFrame: ~6 months (post-op weeks 1, 2, 3, 4, 5, 6, 10, 14, 18, 22; +/- 2 weeks each time in case conflicts arise)
Other outcomes:
Locations:
city: Metairie
country: United States
facility: LSU Healthcare Network Clinic
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Baptist Medical Center
state: Louisiana
Study officials:
affiliation: Louisiana State University Health Sciences Center - New Orleans
name: Alison Smith, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.